Sponsor: Bristol-Myers Squibb (industry)
Phase: 2/3
Start date: Dec. 31, 2025
Planned enrollment: 990
BNT327 (also known as PM8002) is an investigational bispecific antibody that targets PD‑L1 and VEGF‑A. It originated at Biotheus and is now being advanced globally by BioNTech following a licensing deal in November 2023 and a subsequent acquisition agreement announced in November 2024. Clinical development includes Phase Ib/IIa monotherapy and multiple Phase II combination studies across solid tumors. Notably, the agent is also being studied in combination with BioNTech’s TROP2 antibody–drug conjugate BNT325 (DB‑1305). Importantly, DB‑1305 is a separate drug (BNT325), not a synonym for BNT327; the pair is being combined in ongoing trials. (biotheus.com)
BNT327/PM8002 is designed to simultaneously block PD‑L1 to relieve immune checkpoint inhibition and neutralize VEGF‑A to counter tumor angiogenesis. The molecule comprises a bivalent, Fc‑silenced anti‑VEGF‑A IgG1 fused to two humanized anti‑PD‑L1 single‑domain VHHs. Preclinical data show high‑affinity binding to PD‑L1 and VEGF‑A, sub‑nanomolar functional potency in PD‑1/PD‑L1 and VEGF‑A/VEGFR2 signaling assays, and antitumor activity in vivo. The design aims to concentrate VEGF blockade within PD‑L1–positive tumor microenvironments to enhance efficacy and reduce systemic VEGF‑related toxicity. (aacrjournals.org)
Basket/solid tumors (Phase Ib/IIa, monotherapy): In an update through February 3, 2023 (n=263 enrolled; 211 evaluable), overall ORR was 15.2% with a disease control rate (DCR) of 75.4% across tumor types. Signal was observed in several cohorts: cervical cancer ORR 28% (7/25), renal cell carcinoma ORR 26.9% (7/26), platinum‑resistant ovarian cancer ORR 15.4% (4/26), and EGFR‑mutant NSCLC ORR 18.5% (5/27). (ascopubs.org)
Cervical cancer and platinum‑resistant recurrent ovarian cancer (PROC) (ASCO 2024, monotherapy subset): As of December 20, 2023, among 45 evaluable cervical cancer patients, ORR was 42.2% (including 1 CR) with DCR 93.3% and median PFS 8.3 months; PD‑L1–positive (CPS ≥1) tumors had ORR 52.4% (11/21). Among 34 evaluable PROC patients, ORR was 20.6% with DCR 67.7% and median PFS 5.3 months. (ascopubs.org)
NSCLC (ASCO 2024, monotherapy): In 61 evaluable patients with advanced NSCLC, ORR and PFS varied by cohort. Treatment‑naïve cohort (n=17) had ORR 47.1% and median PFS 10.9 months; prior EGFR‑TKI cohort (n=36) had ORR 19.4% and median PFS 4.9 months; a heavily pretreated cohort (IO and platinum‑based chemotherapy) had ORR 12.5% with median PFS 6.7 months. (ascopubs.org)
IO + ADC combination rationale: Early preclinical/clinical evidence presented in 2025 supports combining BNT327/PM8002 with BNT325/DB‑1305 (TROP2 ADC) to improve efficacy without overlapping toxicities; this combination entered clinical evaluation in 2024 (part of an ongoing Phase 1/2 study). (aacrjournals.org)
Basket/solid tumors (Phase Ib/IIa, monotherapy; data to February 3, 2023): Any‑grade treatment‑related adverse events (TRAEs) occurred in 68.8% with grade ≥3 TRAEs in 18.3%. Common TRAEs included proteinuria (17.5%), hypertriglyceridemia (11.4%), elevated AST (9.9%) and ALT (9.5%), hypoalbuminemia (8.7%), and elevated GGT (6.8%). Discontinuations due to TRAEs occurred in 13.7%; no treatment‑related deaths were reported. (ascopubs.org)
NSCLC (ASCO 2024, monotherapy): Any‑grade TRAEs occurred in 85.2% with grade ≥3 in 18%. Immune‑related AEs in 37.7%; treatment‑related SAEs in 9.8%; discontinuations due to TRAEs in 8.2%. Common TRAEs (≥15%) included hypertension, hypothyroidism, proteinuria, hypoalbuminemia, hypocalcemia, and elevated AST/LDH. (ascopubs.org)
Cervical cancer and PROC (ASCO 2024, monotherapy subset): Any‑grade TRAEs in 95.4% and grade ≥3 in 35.6%; any‑grade immune‑related AEs in 57.5% (grade ≥3 in 8%). Discontinuations due to TRAEs in 14.9%. Proteinuria, hypertension, anemia, elevated WBC count, and thrombocytosis were among the most common events. (ascopubs.org)
Notes: Clinical outcomes above are from meeting abstracts (interim data) and may evolve with ongoing follow‑up and subsequent publications.
Last updated: Oct 2025
Goal: To compare the safety and antitumor activity of pumitamig plus first-line chemotherapy versus bevacizumab plus first-line chemotherapy in unresectable or metastatic colorectal cancer, and to select a pumitamig dose for the phase 3 portion.
Patients: Adults with previously untreated, histologically confirmed recurrent/metastatic colorectal adenocarcinoma that is unresectable/not amenable to curative surgery and has measurable disease by RECIST v1.1. Tumors must be microsatellite stable/mismatch repair proficient by historical testing (no known dMMR/MSI-H) and must not have a known BRAF V600E mutation by local testing. Key exclusions include untreated CNS metastases, active malignancy within 2 years (with limited exceptions), significant recent cardiovascular/thrombotic disease or uncontrolled hypertension, and any prior systemic anticancer therapy for advanced disease including prior immune checkpoint-directed therapy.
Design: Blinded, randomized, multicenter phase 2/3 study with a dose-finding/selection phase 2 component followed by a confirmatory phase 3 comparison. Participants are randomized to pumitamig-chemotherapy or bevacizumab-chemotherapy regimens, with disease assessments using RECIST v1.1; the phase 3 primary efficacy assessment uses blinded independent central review for PFS.
Treatments: Experimental therapy is pumitamig (BNT327/PM8002) in combination with standard doublet chemotherapy (FOLFOX or FOLFIRI, with CAPOX included in some arms). Pumitamig is an investigational bispecific antibody targeting PD-L1 and VEGF-A, combining checkpoint blockade with anti-angiogenic inhibition to enhance antitumor immunity and modulate tumor vasculature. Early-phase studies in other tumor types have reported high objective response rates when combined with chemotherapy (for example, approximately 55% in EGFR-mutant NSCLC after TKI and >80% in extensive-stage SCLC in initial reports) with a manageable safety profile that includes expected chemotherapy cytopenias and immune-related adverse events. The control therapy is bevacizumab combined with investigator-chosen chemotherapy (FOLFOX or FOLFIRI, with CAPOX included in some arms); bevacizumab is an anti-VEGF-A monoclonal antibody widely used with fluoropyrimidine/oxaliplatin- or irinotecan-based regimens in first-line metastatic colorectal cancer.
Outcomes: Phase 2 primary endpoint is confirmed objective response rate (CR+PR) by investigator-assessed RECIST v1.1, with phase 2 secondary endpoints including investigator-assessed PFS, duration of response, time to response, disease control rate, and selection of the recommended pumitamig dose for phase 3. Phase 3 primary endpoint is progression-free survival by RECIST v1.1 assessed by blinded independent central review. Key phase 3 secondary endpoints include overall survival, objective response rate by central review, and duration of response by central review. Outcomes are followed for up to 5 years.
Burden on patient: Moderate burden. Treatment involves standard-of-care intravenous chemotherapy backbones with an added intravenous biologic (pumitamig or bevacizumab), requiring regular infusion visits and routine laboratory monitoring typical for FOLFOX/FOLFIRI/CAPOX-based care. Imaging will be performed repeatedly for RECIST-based response and PFS assessment over long-term follow-up, and the blinded design with central review may increase scheduling rigor for scans compared with routine practice. No explicit requirement for mandatory biopsies or intensive pharmacokinetic sampling is provided in the available description, suggesting the additional burden beyond standard first-line metastatic CRC management is mainly related to study visit structure, randomization, and protocol-driven assessment timing.
Last updated: Jan 2026
Inclusion Criteria
* Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
* Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
* Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
* Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria
* Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
* Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
* Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
* Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Brisbane, Queensland, 4029, Australia
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Elizabeth Vale, South Australia, 5112, Australia
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Los Angeles, California, 90033, United States
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Cape Coral, Florida, 33990, United States
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St. Petersburg, Florida, 33705, United States
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Maple Grove, Minnesota, 55369, United States
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St Louis, Missouri, 63110, United States
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Norfolk, Virginia, 23502, United States
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Vancouver, Washington, 98684, United States
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Buenos Aires, C1280AEB, Argentina
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Brussels, 1000, Belgium
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Porto Alegre, Rio Grande do Sul, 91610-000, Brazil
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Santa Cruz do Sul, Rio Grande do Sul, 96810-110, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Chapecó, Santa Catarina, 89812-211, Brazil
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Barretos, São Paulo, 14784400, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Recoleta, Santiago Metropolitan, 8420391, Chile
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Santiago, Santiago Metropolitan, 7620002, Chile
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Santiago, Santiago Metropolitan, 7500921, Chile
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Shanghai, 200032, China
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Beijing, 100034, China
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Wuhan, 430022, China
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Nanjing, Jiangsu, 210009, China
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Hangzhou, 310009, China
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Hefei, Anhui, 230601, China
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Chongqing, Chongqing Municipality, 400030, China
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Fuzhou, Fujian, 350014, China
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Fuzhou Fujian, Fujian, 350001, China
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Guangzhou, Guangdong, 510555, China
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Guangzhou, Guangdong, 510000, China
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Tianjin, Hebei, 300060, China
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Harbin, Heilongjiang, 150081, China
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Nanyang, Henan, 473009, China
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Wuhan, Hubei, 430079, China
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Changsha, Hunan, 410013, China
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Changsha, Hunan, 410031, China
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Yangzhou, Jiangsu, 225001, China
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Nanchang, Jiangxi, 330006, China
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Shenyang, Liaoning, 110001, China
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Shenyang, Liaoning, 110042, China
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Jinan, Shandong, 250117, China
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Shanghai, Shanghai Municipality, 200120, China
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Chengdu, Sichuan, 610041, China
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Hangzhou, Zhejiang, 310003, China
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Hangzhou, Zhejiang, 310022, China
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77520, Czechia
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Prague, Praha 10, 10034, Czechia
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Prague, Praha 5, 150 06, Czechia
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Prague, Praha, Hlavní Mesto, 12808, Czechia
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Toulose, 31059, France
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Villejuif, 94805, France
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Rouen, 76000, France
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Dijon, 21000, France
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Pessac, 33064, France
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Limoges, 87042, France
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Marseille, Bouches-du-Rhône, 13385, France
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Besançon, Doubs, 25000, France
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Saint-Herblain, Loire-Atlantique, 44805, France
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Lorient, Morbihan, 56100, France
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Lille, Nord, 59020, France
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Nantes, Pays de la Loire Region, 44093, France
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Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France
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Berlin, 10117, Germany
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Ulm, 89081, Germany
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Hamburg, 20249, Germany
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Frankfurt, 60488, Germany
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Leipzig, D-04103, Germany
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Düsseldorf, 40479, Germany
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Göttingen, 37075, Germany
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Mannheim, 68167, Germany
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Mainz, 55131, Germany
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Bochum, 44791, Germany
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Chemnitz, 09113, Germany
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Hamburg, 22763, Germany
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Erlangen, Bavaria, 91054, Germany
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Hanover, Lower Saxony, 30161, Germany
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Delhi, 110029, India
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Pune, 411001, India
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Milan, 20133, Italy
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Padova, 35128, Italy
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Pisa, 56126, Italy
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Catania, 95124, Italy
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Avellino, 83100, Italy
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Ravenna, 48121, Italy
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La Spezia, 19124, Italy
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Castellana Grotte, Bari, 70013, Italy
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San Giovanni Rotondo, Foggia, 71013, Italy
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Tricase, Lecce, 73039, Italy
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Milan, Milano, 20162, Italy
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Fukuoka, 811-1395, Japan
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Sunto-gun, 411-8777, Japan
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Sendai, 980-8574, Japan
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Chikusa-ku, 464-8681, Japan
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Kashiwa, 277-8577, Japan
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Osaka, 541-8567, Japan
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Chiba, Chiba, 260-8717, Japan
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Matsuyama, Ehime, 791-0280, Japan
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Kobe, Hyōgo, 6500047, Japan
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Yokohama, Kanagawa, 2418515, Japan
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Kurashiki, Okayama-ken, 710-8602, Japan
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Takatsuki, Osaka, 569-8686, Japan
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Hidaka, Saitama, 350-1298, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Utrecht, 3543 AZ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Tilburg, 5022 GC, Netherlands
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Eindhoven, North Brabant, 5623 EJ, Netherlands
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Amsterdam, North Holland, 1105 AZ, Netherlands
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Opole, 45-372, Poland
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Krakow, Lesser Poland Voivodeship, 31-826, Poland
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Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland
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Warsaw, Masovian Voivodeship, 03-411, Poland
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Brzozów, Podkarpackie Voivodeship, 36-200, Poland
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Gdansk, Pomeranian Voivodeship, 80-219, Poland
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Gliwice, Silesian Voivodeship, 44-101, Poland
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Koszalin, West Pomeranian Voivodeship, 75-581, Poland
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Bucharest, 22328, Romania
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Craiova, 200347, Romania
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Cluj-Napoca, Cluj, 400162, Romania
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Singapore, 119074, Singapore
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Singapore, Central Singapore, 168583, Singapore
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Seoul, 120-752, South Korea
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Seongnam, Gyeonggido, 13620, South Korea
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Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
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Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea
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Málaga, 29011, Spain
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Seville, 41013, Spain
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Elche (alicante), 03203, Spain
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Santiago de Compostela, 15706, Spain
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Salamanca, 37007, Spain
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Badalona, Barcelona [Barcelona], 08916, Spain
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Barcelona, Barcelona [Barcelona], 08035, Spain
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Madrid, Madrid, Comunidad de, 28041, Spain
No email / No phone
Status: Not yet recruiting
Madrid, Madrid, Comunidad de, 28034, Spain
No email / No phone
Status: Not yet recruiting
Pamplona, Navarre, 31009, Spain
No email / No phone
Status: Not yet recruiting
Lund, 22184, Sweden
No email / No phone
Status: Not yet recruiting
Stockholm, Stockholm County, 17176, Sweden
No email / No phone
Status: Not yet recruiting
Gothenburg, Västra Götaland County, 41685, Sweden
No email / No phone
Status: Not yet recruiting
Kaohsiung City, 807, Taiwan
No email / No phone
Status: Not yet recruiting
Tainan, Taiana, 704, Taiwan
No email / No phone
Status: Not yet recruiting
Taipei, 100229, Taiwan
No email / No phone
Status: Not yet recruiting
Taipei, 11217, Taiwan
No email / No phone
Status: Not yet recruiting
Taoyuan District, 333, Taiwan
No email / No phone
Status: Not yet recruiting
Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
No email / No phone
Status: Not yet recruiting
Erzurum, 25070, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Adana, 1370, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Ankara, 06100, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Kadiköy/Istanbul, 41380, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Istanbul, 34214, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Glasgow, G12 0YN, United Kingdom
No email / No phone
Status: Not yet recruiting
Newcastle upon Tyne, NE7 7DN, United Kingdom
No email / No phone
Status: Not yet recruiting
Cardiff, CF14 2TL, United Kingdom
No email / No phone
Status: Not yet recruiting
Dorchester, DT1 2JY, United Kingdom
No email / No phone
Status: Not yet recruiting
Enfield, London, EN28JL, United Kingdom
No email / No phone
Status: Not yet recruiting
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
No email / No phone
Status: Not yet recruiting
Birmingham, West Midlands, B15 2TT, United Kingdom
No email / No phone
Status: Not yet recruiting
Tucson, Arizona, 85724, United States
No email / No phone
Status: Not yet recruiting
Springdale, Arkansas, 72762, United States
No email / No phone
Status: Not yet recruiting
Stanford, California, 94305, United States
No email / No phone
Status: Not yet recruiting
San Francisco, California, 94115, United States
No email / No phone
Status: Not yet recruiting
Santa Monica, California, 90404, United States
No email / No phone
Status: Not yet recruiting
Orange, California, 92868, United States
No email / No phone
Status: Not yet recruiting
Tampa, Florida, 33612, United States
No email / No phone
Status: Not yet recruiting
Duluth, Georgia, 30096, United States
No email / No phone
Status: Not yet recruiting
Chicago, Illinois, 60611, United States
No email / No phone
Status: Not yet recruiting
Chicago, Illinois, 60637, United States
No email / No phone
Status: Not yet recruiting
Iowa City, Iowa, 52242, United States
No email / No phone
Status: Not yet recruiting
Baltimore, Maryland, 21287, United States
No email / No phone
Status: Not yet recruiting
Grand Rapids, Michigan, 49546, United States
No email / No phone
Status: Not yet recruiting
Ann Arbor, Michigan, 48109, United States
No email / No phone
Status: Not yet recruiting
Kansas City, Missouri, 64111, United States
No email / No phone
Status: Not yet recruiting
Omaha, Nebraska, 68198, United States
No email / No phone
Status: Not yet recruiting
Mineola, New York, 11501, United States
No email / No phone
Status: Not yet recruiting
New Hyde Park, New York, 11042, United States
No email / No phone
Status: Not yet recruiting
Charlotte, North Carolina, 28207, United States
No email / No phone
Status: Not yet recruiting
Fargo, North Dakota, 58102, United States
No email / No phone
Status: Not yet recruiting
Columbus, Ohio, 43210, United States
No email / No phone
Status: Not yet recruiting
Oklahoma City, Oklahoma, 73104, United States
No email / No phone
Status: Not yet recruiting
Pittsburgh, Pennsylvania, 15232, United States
No email / No phone
Status: Not yet recruiting
Sioux Falls, South Dakota, 57104, United States
No email / No phone
Status: Not yet recruiting
Nashville, Tennessee, 37203, United States
No email / No phone
Status: Not yet recruiting
Houston, Texas, 77030, United States
No email / No phone
Status: Not yet recruiting
Salt Lake City, Utah, 84102, United States
No email / No phone
Status: Not yet recruiting
Fairfax, Virginia, 22031, United States
No email / No phone
Status: Not yet recruiting
Seattle, Washington, 98109, United States
No email / No phone
Status: Not yet recruiting
Edmonds, Washington, 98026-8032, United States
No email / No phone
Status: Not yet recruiting
Boston, Massachusetts, 02114, United States
No email / No phone
Status: Withdrawn