Investigational Drug
BNT324
TrialFetch AI Analysis
Show TrialFetch AI Analysis
Overview
BNT324 (DB-1311) is an investigational antibody–drug conjugate being studied for advanced solid tumors. Human results are available from an ongoing phase 1/2 study, but the reported efficacy findings are preliminary; the cited efficacy analyses do not compare BNT324 with another treatment. (ascopubs.org)
Mechanism of action
The antibody targets B7-H3 and is linked to a topoisomerase I inhibitor payload, intended to deliver the cancer-killing drug to B7-H3–expressing cells. (asco.org)
Efficacy
- Metastatic castration-resistant prostate cancer: In a 2026 conference abstract, 20 of 58 patients with measurable disease had a confirmed response (34.5%). Median radiographic progression-free survival was 11.3 months among 82 evaluable patients. (ascopubs.org)
- Cervical and ovarian cancer: A separate abstract reported confirmed response rates of 35.7% (10 of 28) in previously treated cervical cancer and 58.3% (7 of 12) in platinum-resistant ovarian cancer. These were small cohorts. (annalsofoncology.org)
- Small-cell lung cancer: An earlier dose-finding analysis reported an unconfirmed response rate of 45.5% among 33 patients. (annalsofoncology.org)
Safety
In the initial 126-patient dose-finding analysis, 31.7% had grade 3 or higher treatment-related adverse events. Common events included nausea and reduced blood-cell counts; 5.6% discontinued treatment because of an adverse event. In the later 42-patient cervical/ovarian analysis, 54.8% had grade 3 or higher treatment-related adverse events, mainly hematologic, and 7.1% discontinued treatment because of them. Safety rates from these different cohorts should not be treated as directly comparable. (annalsofoncology.org)
Further reading
- 2026 prostate cancer study abstract
- 2025 cervical and ovarian cancer study abstract
- Initial dose-finding study abstract
Last updated: Sep 2026
Active trials using BNT324
Found 3 active trials using this drug:
TrialFetch AI summary: Men with progressive mCRPC, ECOG 0–1, and progression after one or two androgen receptor pathway inhibitors are eligible if they have not received cytotoxic chemotherapy for mCRPC. Patients are randomized to BNT324 (DB-1311), a B7-H3–targeted antibody–drug conjugate carrying a topoisomerase I inhibitor, or docetaxel plus prednisone/prednisolone.
ClinicalTrials.gov ID: NCT07365995
TrialFetch AI summary: Adults with unresectable advanced or metastatic NSCLC or SCLC, including first-line and previously treated cohorts, receive BNT324 (DB-1311), a B7-H3–targeted antibody–drug conjugate carrying a topoisomerase I inhibitor, plus BNT327 (pumitamig), a PD-L1/VEGF-A bispecific antibody. The study evaluates combination dosing, safety, and preliminary antitumor activity without a standard-of-care comparator.
ClinicalTrials.gov ID: NCT06892548
TrialFetch AI summary: Adults with previously treated, unresectable advanced or metastatic solid tumors and ECOG performance status 0–1 receive intravenous DB-1311/BNT324 every 21 days in dose-escalation or tumor-specific expansion cohorts. DB-1311/BNT324 is an investigational B7-H3–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload; prior B7-H3–targeted therapy or a topoisomerase inhibitor–payload ADC is excluded.
ClinicalTrials.gov ID: NCT05914116
