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A Study of TPD3310 in Patients With Advanced Malignant Tumors

NCT07368127 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

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.

Sponsors & Collaborators

  • TAIBIDI PHARMACEUTICAL TECHNOLOGY(SHIJIAZHUANG) CO.,LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-03-01
Completion
2029-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07368127 on ClinicalTrials.gov