Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies (NCT07504263) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies
66 participantsStarted 2026-04-23
Plain-language summary
Phase 1/2a Study of RP-001 in participants with Advanced Malignancies
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
To characterize the safety and tolerability of RP-001 administered as monotherapy.