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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 29, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06953089). This is a study registration, not published results. Lead sponsor: DualityBio Inc.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 750 participants (ESTIMATED). Conditions: Solid Tumors. Interventions: DRUG: DB-1311/BNT324; DRUG: BNT327; DRUG: DB-1305/BNT325. Primary outcome measures: Part 1: Number of participants with Dose Limiting Toxicities (DLTs). , During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days; Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) , up to follow up period, e.g. up to 72 months.; Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response by arm and dose level. (Arm 1-9). , From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months; ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per PCWG3-modified RECIST v1.1 as assessed by investigator) (Arm 10). , From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months. Brief summary: A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors