Study of M1774 in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)

• Status: Not yet recruiting
• Trial end date: 2023-12-12
• Target enrollment: 0
• Participant gender: All

Summary

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 Drug A (DNA Damage Response Inhibitor - in Part A1) and in combination with Drug B (Immune Checkpoint Inhibitor - in Part B1) in participants with metastatic or locally advanced unresectable solid tumors who are intolerant or have no standard therapy available.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Treatments: Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

• Participants with metastatic or locally advanced unresectable solid tumors refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator, which may convey clinical benefit, or who cannot tolerate standard of care treatment

• Participants with eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, with estimated life expectancy of at least 3 months

• Adequate hematological, hepatic, and renal function as defined in the protocol

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Participants with any condition, including any uncontrolled disease state other than with metastatic or locally advanced unresectable solid tumors, that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation

• Participants with a known additional malignancy that is progressing and/or requires active treatment

• Participants with carcinomatous meningitis are excluded regardless of clinical stability

• Participants with serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease, and/or other situations that may preclude adequate absorption of oral medications

• Participants with organ transplantation, including allogeneic stem cell transplant

• Other protocol defined exclusion criteria could apply