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

NCT05155722 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-12-08

No results posted yet for this study

Summary

A phase I dose escalation and cohort expansion study to evaluate the safety, tolerance and pharmacokinetic of BAT1308 injection in patients with advanced solid tumors

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.

Sponsors & Collaborators

Principal Investigators

  • Suxia Luo, M.D · Henan Tumor Hospital

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
2020-09-17
Primary Completion
2024-07-09
Completion
2024-07-09

Countries

  • China

Study Locations

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Entities

Companies

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 NCT05155722 on ClinicalTrials.gov