Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy with BAT1308 in Advanced Solid Tumors

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

September 17, 2020

Primary Completion Date

March 31, 2025

Study Completion Date

December 31, 2025

Conditions
Advanced Solid Tumor
Interventions
DRUG

BAT1308

A 21 day treatment cycle was administered every 3 weeks (Q3W) on day 1 of each cycle. Six consecutive dosing cycles are recommended for the dose escalation phase. In the extended study phase, after the end of the 6th treatment cycle, after the risk and benefit are evaluated by the investigator in combination with the clinical practice, if the subjects are still in a state of clinical benefit (including CR, PR and SD), the investigator can decide to appropriately extend the treatment of BAT1308. Until disease progression, unacceptable toxicity, withdrawal of informed consent, loss of follow-up, death, acceptance of new antitumor therapy, termination of treatment by investigator evaluation, or 12 months after initial administration, whichever is the earliest.

Trial Locations (1)

450003

Henan Tumor Hospital, Zhengzhou

Sponsors
All Listed Sponsors
lead

Bio-Thera Solutions

INDUSTRY

NCT05155722 - Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy with BAT1308 in Advanced Solid Tumors | Biotech Hunter | Biotech Hunter