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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
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
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.
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