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RECRUITING
NCT05909241
PHASE1

A Study of BA1202 in Patients With Advanced Solid Tumors

Sponsor: Shandong Boan Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, single-arm phase I study in patients with advanced solid tumors which consists of a dose escalation part (Part A) and a dose extension part (Part B). Part A aims to evaluate the safety and tolerability of BA1202, and determine the MTD. Part B will also evaluate the preliminary efficacy of BA1202.

Official title: A Multicenter, Open-label, Single-arm, Dose Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1202 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2023-08-16

Completion Date

2026-12

Last Updated

2024-04-25

Healthy Volunteers

No

Interventions

DRUG

BA1202

BA1202 will be administered intravenously (IV) once every 3 weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the duration of administration was no more than 2 years. Part A: Patients will receive one of the following dosages of BA1202: 0.016mg, 0.08mg, 0.4mg, 1.6mg, 6.4mg, 19mg, 38mg, 56mg. Part B: Based on the data of part A, one or two dose levels will be discussed for further evaluation in part B.

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China