This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
This is a Phase I, 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. Number of subjects : 1. 39-51 subjects for Dose escalation phase part 1 2. Maximum of 18 subjects or Dose escalation phase part 2 3. 24-34 subjects per Dose expansion cohort
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
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.
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.
Calvary Mater Newcastle
Sydney, New South Wales, Australia
RECRUITINGPindara Private Hospital
Benowa, Queensland, Australia
RECRUITINGSouthern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Incidence of adverse events and server adverse events
Will be graded according to the NCI-CTCAE Grading Scale version 5.0.
Time frame: One year after last patient first dose
DLT
Number of Participants with Dose Limiting Toxicity
Time frame: Up to 21 Days
MTD
Maximum tolerated dose of ATG-037
Time frame: Up to 21 Days
RP2D
Recommended phase 2 dose of ATG-037
Time frame: Up to 21 Days
Plasma concentration of ATG-037 and derived PK parameters
To characterize the PK/PDx of ATG-037
Time frame: One year after last patient first dose
Inhibition of CD73 enzymatic activity in plasma
To evaluate the preliminary antitumor activity of ATG-037 monotherapy and combination therapy with pembrolizumab
Time frame: One year after last patient first dose
ORR as per RECIST v1.1 and DOR, DCR, PFS, OS evaluated by the investigators
To evaluate the preliminary antitumor activity of ATG-037 monotherapy and combination therapy with pembrolizumab
Time frame: One year after last patient first dose
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Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
RECRUITINGOne Clinical Research Pty Ltd
Mount Pleasant, Western Australia, Australia
RECRUITINGChongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
TERMINATEDGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
TERMINATED