Clinical trialPhase 1 / Phase 2Active not recruiting
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 19 July 2022
- Expected end
- 10 September 2027
- Enrollment
- 1,123 participants
- Sites
- 93
- Primary outcomes
- Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.; Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.; Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.; Maximum Tolerated Dose (MTD) of DB-1305/BNT325; Phase 1: RP2D of DB-1305/BNT325
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 12 May 2026
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Brief summary public domain (ClinicalTrials.gov)
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.
Detailed description public domain (ClinicalTrials.gov)
This is a multicenter, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.