Study of M1774 in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)
About the study
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) 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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Metastatic or Locally Advanced Unresectable Solid Tumors
Age (in years)
18+
Phase
Phase 1
Participants needed
72
Est. Completion Date
Dec 12, 2023
Treatment type
Interventional
Sponsor
EMD Serono
ClinicalTrials.gov identifier
NCT05396833
Study number
MS201924_0020
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