A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Condition studied

Non-small cell lung cancer (NSCLC), Cervical cancer (CC), Melanoma, Hepatocellular carcinoma (HCC), Ovarian cancer (OC), Squamous cell carcinoma of head and neck

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part 1: Number of participants with Dose Limiting Toxicities (DLTs), Part 1: Treatment emergent adverse events (TEAEs) and treatment emergent serious AE (TESAEs), Part 2: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST v1.1 based on the investigator’s assessment)., Part 2: Safety and tolerability: TEAEs and TESAEs

Endpoint detail

Part 1: Efficacy evaluations: objective response rate (ORR), defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator’s assessment), Part 1: Duration of response (DoR), disease-control rate (DCR), Time to Response (TTR), Progression Free Survival (PFS) will be determined from tumor assessments by Investigator per RECIST v1.1., Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with platinumresistant ovarian cancer (PROC)., Part 1: Overall Survival (OS), Part 1: PK parameters of DB-1311 antibody-drug conjugate (ADC), total antibody, and unconjugated P1021 in combination with BNT327 or in combination with DB-1305., Part 1: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA., Part 2: DoR, DCR, TTR, and PFS determined by Investigator as per RECIST v1.1, Part 2: Safety and tolerability: TEAEs and TESAEs, Part 2: OS, Part 2: PK parameters of DB-1311 ADC, total anti-B7H3 antibody, and unconjugated P1021., Part 2: ADA prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA.