Clinical trial · Interventional
Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies
An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of RP-001 in Participants With Advanced Malignancies
NCT07504263CI-TRIAL-00106888not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase 1/2a Study of RP-001 in participants with Advanced Malignancies
Conditions
Conditions (5)
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 Malignancies | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Oncology | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RP-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 12mg of RP-001
- description
- The study will begin with 12mg of RP-001.
- interventionNames
- Drug: RP-001
- type
- EXPERIMENTAL
- label
- 25mg of RP-001
- description
- Dose level 2 will be 25mg as determined by safety.
- interventionNames
- Drug: RP-001
- type
- EXPERIMENTAL
- label
- 75mg of RP-001
- description
- Dose level 3 will be 75mg of RP-001 as determined by safety
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female participants aged 18 years or older with advanced or metastatic cancer, which must be measurable per RECIST v1.1 and satisfy the following criteria: * Phase 1: Participants with solid tumors who are candidates for treatment with a taxane * Phase 2a: Participants with relapsed or refractory PDAC, or CRC. Exclusion Criteria: * 1\. Active infection requiring systemic anti-infective therapy within 28 days prior to first dose of RP-001. 2\. Cardiovascular disease, including: a. Unstable angina; b. symptomatic peripheral arterial vascular disease; c. Myocardial infarction within 6 months prior to RP-001 administration; d. New York Heart Association Class III or IV heart failure; e. Uncontrolled arrythmia; f. ECG abnormality that, in the opinion of the Investigator, increases the risks associated with participating in the trial. 3\. Concurrent systemic anti-cancer therapy other than luteinizing hormone-releasing hormone (LH-RH) agonists. 4\. Pregnancy, or breastfeeding. 5. Untreated central nervous system metastasis, or carcinomatous meningitis. 6. Any concurrent severe and/or uncontrolled medical or surgical condition which, in the opinion of the Investigator, may compromise the participant's involvement in the trial due to safety, compliance concerns or ability to evaluate response.
References
Publications (0)
Data not yet available
No reference posted for this study.