Brief Summary
This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.
Intervention / Treatment
- Drug: MOMA-341
- Drug: Irinotecan
- Drug: Immunotherapya treatment that uses a person's immune system to fight cancer
Inclusion Criteria:
- Age ≥ 18 years.
- Participants have unresectable advancedat a late stage, far along or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen.a. Prior anti-PD(L)1-based regimen is not required if participant is ineligible for anti-PD(L)1-based regimen (eg, due to autoimmune conditions).
- Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3.
- ECOG PS ≤ 2.
- Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery **hormonal therapy allowed. Palliative radiotherapy allowed.
- Adequate organ function per local labs.
- Comply with contraception requirements.
- Written informed consent must be obtained according to local guidelines.