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Assessment of Safety and Preliminary Clinical Efficacy with BAT6005 in Advanced Malignant Solid Tumors

NCT05116709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-27

No results posted yet for this study

Summary

This research design for center, increasing openness, dose and dose extension phase I clinical trials, research the main evaluation BAT6005 injection single drug in patients with advanced malignant solid tumors in the safety, tolerability and PK characteristics, to explore the maximum tolerated dose and preliminary antitumor efficacy, provide the basis for subsequent clinical trials recommended dose.

Part I: single drug dose escalation study. Part TWO: dose extension study.

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Interventions

DRUG

BAT6005 injection

Six dose groups were set up, including 10mg (initial dose) group, 30mg group, 100mg group, 300mg group, 600mg group and 900mg group, respectively.

Sponsors & Collaborators

Principal Investigators

  • Jin Li · Shanghai Oriental hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2024-01-10
Completion
2024-09-23

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 NCT05116709 on ClinicalTrials.gov