BNT327

TrialFetch AI summary: Adults with previously untreated, unresectable or metastatic colorectal adenocarcinoma with measurable disease that is MSS/pMMR and without known BRAF V600E are randomized (blinded) to first-line doublet chemotherapy (FOLFOX/FOLFIRI ± CAPOX) plus pumitamig (BNT327/PM8002), a bispecific anti–PD-L1/anti–VEGF-A antibody, versus the same chemotherapy plus bevacizumab. Primary efficacy focuses on objective response in the dose-selection portion and progression-free survival by blinded central review in the confirmatory portion.

ClinicalTrials.gov ID: NCT07221357

TrialFetch AI summary: Adults with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (including ER-low/HER2-negative) whose tumors are PD-L1–negative or otherwise ineligible for standard PD-(L)1 inhibitor plus chemotherapy receive physician’s choice chemotherapy (paclitaxel/nab-paclitaxel, gemcitabine/carboplatin, or eribulin). Patients are randomized double-blind to add pumitamig (BNT327), a bispecific anti–PD-L1/anti–VEGF-A antibody (checkpoint blockade plus anti-angiogenic therapy), versus placebo.

ClinicalTrials.gov ID: NCT07173751

TrialFetch AI summary: Adults with advanced/metastatic NSCLC (squamous or non-squamous), including both first-line AGA-negative and previously treated patients (with genotype-specific prior therapy, e.g., post–third-gen EGFR TKI), receive the HER3-directed topoisomerase I ADC BNT326 combined with the PD-L1/VEGF-A bispecific antibody BNT327, with arms also testing each agent alone and standard-of-care comparators by PD-L1 status. Excludes prior HER3/topo I ADC exposure (with limited exceptions), uncontrolled ILD/pneumonitis, active CNS disease needing steroids/anticonvulsants, significant effusions, and high-grade prior irAEs leading to ICI discontinuation.

ClinicalTrials.gov ID: NCT07111520

TrialFetch AI summary: Adults with advanced/metastatic solid tumors (select cohorts: 2L+ cutaneous melanoma, EGFR-mutated or EGFR/ALK/ROS1–negative NSCLC, rare melanomas, other solid tumors; and in combination: 2L+ melanoma and HER2‑negative metastatic breast cancer) receive the HER3-targeting antibody–drug conjugate BNT326 (topoisomerase I payload) as monotherapy or combined with BNT327, a bispecific anti–PD-L1/anti–VEGF-A antibody. Includes a dedicated drug–drug interaction cohort with CYP inhibitors (itraconazole or paroxetine).

ClinicalTrials.gov ID: NCT07070232

TrialFetch AI summary: Adults with unresectable, MSS/pMMR metastatic colorectal adenocarcinoma (ECOG 0–1) are treated with BNT314 (bispecific EpCAM×4‑1BB agonist delivering EpCAM-restricted costimulation) plus BNT327 (bispecific PD‑L1×VEGF‑A inhibitor) with standard chemotherapy across lines of therapy, with Phase 2 randomization versus bevacizumab + chemotherapy or BNT327 + chemotherapy. Excludes MSI‑H/dMMR and prior EpCAM/4‑1BB, checkpoint inhibitor, or PD‑(L)1/VEGF bispecific exposure, and patients with uncontrolled CNS disease or significant cardiovascular/autoimmune risks.

ClinicalTrials.gov ID: NCT07079631

TrialFetch AI summary: Enrolls adults with advanced/metastatic solid tumors—HCC (Child-Pugh A), cervical, melanoma, recurrent/metastatic HNSCC, platinum‑resistant high‑grade serous ovarian, and nonsquamous NSCLC without actionable drivers—ECOG 0–1 and measurable disease. Investigational therapy pairs the B7‑H3–targeted topoisomerase‑I ADC DB‑1311 with either BNT327 (PD‑L1/VEGF‑A bispecific) for HCC/cervical/melanoma/HNSCC or with the TROP2‑directed topoisomerase‑I ADC DB‑1305 for NSCLC.

ClinicalTrials.gov ID: NCT06953089

TrialFetch AI summary: Adults with unresectable, advanced, or metastatic NSCLC or SCLC—including both treatment-naïve and previously treated patients—are eligible for this trial evaluating BNT324, a B7-H3-targeted antibody-drug conjugate, in combination with BNT327, a bispecific antibody targeting PD-L1 and VEGF-A. Separate cohorts include NSCLC with and without actionable oncogenic alterations and both first- and later-line treatment settings.

ClinicalTrials.gov ID: NCT06892548

TrialFetch AI summary: This trial enrolls patients with advanced, locally unresectable or metastatic breast cancer of any HER2 status (including HER2-positive, HER2-low, HER2-ultralow, HER2-negative/triple-negative), investigating the combination of BNT323 (a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) and BNT327 (a bispecific antibody targeting PD-L1 and VEGF-A), with some arms evaluating each agent as monotherapy. Eligible patients are generally pretreated with chemotherapy and must have measurable disease.

ClinicalTrials.gov ID: NCT06827236

TrialFetch AI summary: This trial targets patients with Stage IV NSCLC who have progressed after first-line chemoimmunotherapy and explores the combination of BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, with docetaxel.

ClinicalTrials.gov ID: NCT06841055

TrialFetch AI summary: Adults with previously untreated extensive-stage small-cell lung cancer (ECOG 0–1, measurable disease; prior curative-intent chemoradiotherapy for limited-stage allowed if ≥6 months since treatment) are randomized to platinum/etoposide plus pumitamig (BNT327; investigational PD-L1/VEGF-A bispecific antibody combining checkpoint blockade with anti-angiogenic activity) versus the standard atezolizumab plus platinum/etoposide, followed by maintenance with the assigned immunotherapy. Patients with combined SCLC histology, prior PD-(L)1/VEGF-targeted therapy, high bleeding/wound-healing risk, or untreated/symptomatic/large CNS metastases/leptomeningeal disease are excluded.

ClinicalTrials.gov ID: NCT06712355

TrialFetch AI summary: Eligible patients are adults with advanced (stage IIIB/C or IV) non-small cell lung cancer lacking EGFR/ALK alterations, randomized to receive either BNT327—a bispecific antibody targeting PD-L1 and VEGF-A—in combination with chemotherapy, or standard pembrolizumab plus chemotherapy as first-line treatment.

ClinicalTrials.gov ID: NCT06712316