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Spots Global Cancer Trial Database for Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT1308 in Advanced Solid Tumors

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Trial Identification

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

Official Title: 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

Study ID: NCT05155722

Interventions

BAT1308

Study Description

Brief 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

Detailed Description: This study is a multicenter, open, dose-increasing and dose-expanding phase I clinical study. The dose increasing method of "3 + 3" is used to explore the safety, tolerance and pharmacokinetic characteristics of BAT1308 injection in patients with advanced solid tumors (12-18 cases). After the completion of dose increment, 300mg tolerated doses were selected for extended research on advanced non-small cell lung cancer, advanced hepatocellular carcinoma and cervical cancer (80-130 cases), so as to provide recommended doses for subsequent clinical trials.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Henan Tumor Hospital, Zhengzhou, Henan, China

Contact Details

Name: Suxia Luo, M.D

Affiliation: Henan Tumor Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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