NCT07368127

A Study of TPD3310 in Patients With Advanced Malignant Tumors

A Single-Arm, Open-Label, Dose-Escalation/Cohort-Expansion Phase Ia/Ib Study to Evaluate Safety, Tolerability, PK/PD Profiles, and Preliminary Efficacy of TPD3310 Injection in Advanced Malignant Solid Tumor Patients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: TAIBIDI PHARMACEUTICAL TECHNOLOGY(SHIJIAZHUANG) CO.,LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open phase I clinical study of dose escalation,cohort expansion study to evaluate the safety,tolerability,pharmacokinetics,pharmacodynamics, and preliminary efficacy of TPD3310 in patients withadvanced malignant solid tumors.

Detailed description

TPD3310 is a selective c-MET degrader, and this is the first-in-human trial of TPD3310. This study adopts an open-label, non-randomized, single-arm, dose-escalation, and cohort expansion research design, and is divided into two parts, Phase Ia and Phase Ib. Phase Ia is a single and multiple dose escalation trial with an open-label design, aiming to evaluate the safety, tolerability, PK, and PD characteristics of TPD3310 tablets, preliminarily assess the anti-tumor efficacy, and recommend the dose for Phase Ib study. Phase Ib is a single-arm cohort expansion study conducted in participants with six solid tumors, based on the recommended dosage and dosing cycle from the Phase Ia study. The actual tumor types for the Phase Ib study will be adjusted according to the safety and efficacy data from the Phase Ia study.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	TPD3310 injection	* Phase Ia: Single and Multiple Dose Escalation. (1) Dosage form: injection. (2) Dosage: 6 dose groups, 50 mg, 100 mg, 200 mg, 350 mg, 500 mg, 650 mg,.-Arms Assigned Interventions (3) Frequency: once weekly. (4) Duration: days 1-21; 28 days per cycle. * Phase Ib: Cohort Expansion. Dosage and dosing regimen: according to the recommended dosage and dosing cycle from the Phase Ia study.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2029-03-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: China