Metastatic or Locally Advanced Unresectable Solid Tumors Clinical Trial
Official title:
An Open-label, Multicenter Phase Ib Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the ATR Inhibitor M1774 in Combination With DNA Damage Response Inhibitors or Immune Checkpoint Inhibitors in Patients With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 320)
This is an open-label, multicenter, clinical study conducted in multiple parts to establish the safety, tolerability, Pharmacokinetic/Pharmacodynamic (PK/PD) profile, maximum tolerated dose (MTD) combinations (if observed) and recommended dose for expansion (RDE) combination for M1774 in combination with M4076 (in Part A1), food effect on the PK of M4076 as monotherapy or in combination with M1774 (in Part A1.1), safety/tolerability and early signs of clinical activity of M1774 and M4076 in combination in patients with prostate cancer harboring loss of function (LoS) mutation in the gene ATM based on local data previously generated in circulating tumor (ct) DNA (liquid biopsies) or tumor biopsies (in Part A2), safety/tolerability and early signs of clinical activity of M1774 and M4076 in combination in patients with endometrial cancer harboring LoS mutation(s) in the gene ARID1A based on local data previously generated in ctDNA (liquid biopsies) or tumor biopsies (in Part A3), the relative bioavailability of a M1774 tablet formulation (TF1, test) compared to a capsule formulation (reference) will also be investigated (in Part A2/A3), and in combination with avelumab (in Part B1) in participants with metastatic or locally advanced unresectable solid tumors who are intolerant or have no standard therapy available.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03306420 -
First-in-Human Study of MS201408-0005A as Single Agent and in Combinations
|
Phase 1 | |
| Terminated |
NCT05198349 -
First in Human Study of M1069 in Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04170153 -
Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
|
Phase 1 |