Clinical trial · Interventional
Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients With p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination With Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
| KRT-232 | Drug | Navtemadlin | ALIAS |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- Cohort 1, Arm 1
- description
- KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 21-day cycle.
- interventionNames
- Drug: KRT-232
- type
- EXPERIMENTAL
- label
- Cohort 1, Arm 1b
- description
- KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 23-day cycle.
- interventionNames
- Drug: KRT-232
- type
- EXPERIMENTAL
- label
- Cohort 1, Arm 2b
- description
- KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 28-day cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * For Cohort 1, 3 and 4 patients must have failed treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for metastatic MCC * For Cohort 2, patients must not have received any anti-PD-1 or anti-PD-L1 therapy * For Cohort 3, patients must not have received any prior chemotherapy * For Cohort 4, patients must have received at least one prior line of chemotherapy * ECOG performance status of 0 to 1 * Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST 1.1 * MCC expressing p53WT based on any CLIA or test approved by local health authority or a validated test (Cohort 1 and 2) * MCC expressing p53WT based Central Lab test (Cohort 3 and 4) * Adequate hematological, hepatic, and renal functions Exclusion Criteria: * For Cohort 2, subjects must not have autoimmune disease, medical conditions requiring systemic immunosuppression, prior stem cell transplant, or active infection with HBV or HCV. * Patients previously treated with MDM2 antagonist therapies or p53-directed therapies * History of major organ transplant * Patients with known central nervous system (CNS) metastases that are previously untreated * Grade 2 or higher QTc prolongation (\>480 milli-seconds per NCI-CTCAE criteria, version 5.0)
References
Publications (0)
Data not yet available