Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATG-037 · 1 trial · 1 indication
Will be graded according to the NCI-CTCAE Grading Scale version 5.0.
Number of Participants with Dose Limiting Toxicity
Maximum tolerated dose of ATG-037
Recommended phase 2 dose of ATG-037
| Arm | Type | Description |
|---|---|---|
| ATG-037+Keytruda(Pembrolizumab, MK-3475) | EXPERIMENTAL | Part I: Dose Escalation Phase of ATG-037 Monotherapy PartII: Dose Escalation Phase and Dose Expansion Phase of ATG-037 in Upfront Combination with Keytruda(Pembrolizumab, MK-3475) |
| Name | Type | Description |
|---|---|---|
| ATG-037 | DRUG | 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) | DRUG | 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. |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. Aged at least 18 years as of the date of consent. 3. Unresectable Stage III or Stage IV melanoma patients, who have had disease progression on or after a...