Clinical trial · Interventional
Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors
NCT05147350CI-TRIAL-00098474MINOTAURterminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to terminate the study
Summary
Brief summary (as posted)
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RP-6306 (oral PKMYT1 inhibitor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation
- description
- RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)
- interventionNames
- Drug: RP-6306 (oral PKMYT1 inhibitor)
Primary outcomes (2)
- measure
- Safety and Tolerability of RP 6306 in Combination With FOLFIRI
- timeFrame
- Start of treatment to 30 days post last dose. up to 1.5 years
- description
- Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
- measure
- Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI
- timeFrame
- During 28 days (2 cycles) from the initiation of the study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female and ≥18 years-of-age at the time of signature of the informed consent * Confirmed advanced solid tumors resistant or refractory to standard treatment * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease. * Measurable disease as per RECIST v1.1 * Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible * Acceptable hematologic and organ function at screening * Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug. Exclusion Criteria: * Inability to swallow and retain oral medications. * Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study treatment. * History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment. * Patients who are pregnant or breastfeeding * Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety. * Major surgery within 4 weeks prior to first study treatment dose. * Uncontrolled, symptomatic brain metastases. * Uncontrolled high blood pressure * Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness. * Moderate or severe hepatic impairment * Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2 * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.