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

PHASE1RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

June 7, 2022

Primary Completion Date

August 30, 2027

Study Completion Date

February 28, 2028

Conditions
Locally Advanced or Metastatic Solid Tumors
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."

Trial Locations (7)

2298

RECRUITING

Calvary Mater Newcastle, Sydney

3199

RECRUITING

Peninsula & South Eastern Haematology and Oncology Group, Frankston

4217

RECRUITING

Pindara Private Hospital, Benowa

5042

TERMINATED

Southern Oncology Clinical Research Unit, Bedford Park

400000

TERMINATED

Chongqing Cancer Hospital, Chongqing

510080

TERMINATED

Guangdong Provincial People's Hospital, Guangzhou

WA6153

RECRUITING

One Clinical Research Pty Ltd, Mount Pleasant

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Antengene Therapeutics Limited

INDUSTRY