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RECRUITING
NCT05205109
PHASE1

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors

Sponsor: Antengene Therapeutics Limited

View on ClinicalTrials.gov

Summary

This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Official title: A Phase I/Ib, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2022-06-07

Completion Date

2028-02-28

Last Updated

2025-06-09

Healthy Volunteers

No

Interventions

DRUG

ATG-037

Part I : ATG-037 will be administered orally once a day (QD) on D-2, then multiple doses of ATG-037 will be administered orally BID for every day from C1D1. A treatment cycle will be defined as 21 days. Part II: ATG-037 will be administered orally BID for every day from C1D1.

DRUG

KEYTRUDA ®( Pembrolizumab)

Part I: After 2 cycles of ATG-037 monotherapy, eligible participants will receive ATG-037 combination therapy with Keytruda ®(Pembrolizumab) 200mg/Q3W fixed dose for up to 35 administrations (approximately 2 years). Part II: Keytruda ®(Pembrolizumab) will be administered from C1.

Locations (7)

Calvary Mater Newcastle

Sydney, New South Wales, Australia

Pindara Private Hospital

Benowa, Queensland, Australia

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

One Clinical Research Pty Ltd

Mount Pleasant, Western Australia, Australia

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China