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NOT YET RECRUITING
NCT07842445
PHASE1

Phase 1a/1b Clinical Trials to Evaluate the Safety and Preliminary Efficacy of GNTbm-38.

Sponsor: Great Novel Therapeutics Biotech & Medicals Corporation

View on ClinicalTrials.gov

Summary

This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of GNTbm-38 in adult patients with advanced solid tumors and R/R PTCL.

Official title: A Phase 1a/1b, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GNTbm 38 in Solid Tumors and Relapsed/Refractory Peripheral T-Cell Lymphoma.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-12-01

Completion Date

2029-06-30

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DRUG

GNTbm-38

Phase 1a is the dose escalation phase to firstly determine the MTD of patients with solid tumor. Once MTD for solid tumor patients has been established, the next lower dose of this MTD will serve as an initial dose to determine the MTD for patients with R/R PTCL. Phase 1b is the dose expansion phase to evaluate the safety, tolerability, and efficacy of GNTbm-38 in R/R PTCL patients.