Brief Summary
This Phase 1, multi-center, open-label, dosethe amount of medication taken 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 imagingtests that create detailed images of areas inside the body evaluation by RECIST and/or PCWG-3.
- ECOG PS ≤ 2.
- Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence **hormonal therapy allowed. Palliative radiotherapy allowed.
- Adequate organ function per local labs.
- Comply with contraception requirements.
- Written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. must be obtained according to local guidelines.