A Phase 1/2 interventional study of RP-001 in Advanced Malignancies, Oncology and Colorectal Cancer, sponsored by Recurv Pharma Inc. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Recurv Pharma Inc · Phase 1/2, Interventional, and Treatment
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
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 66 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Recurv Pharma Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
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.
The study will begin with 12mg of RP-001.
Drug: RP-001
Dose level 2 will be 25mg as determined by safety.
Drug: RP-001
Dose level 3 will be 75mg of RP-001 as determined by safety
Drug: RP-001
Dose level 4 will be 150mg of RP-001 as determined by safety.
Drug: RP-001
Dose level 5 will be 250mg as determined by safety.
Drug: RP-001
A new class of Taxane.
To characterize the safety and tolerability of RP-001 administered as monotherapy.
• Dose limiting toxicities (DLTs) and adverse events (AEs) using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v5.0
Time frame: 1 month
To determine the recommended Phase 2 dose
Determination of maximum tolerated dose level
Time frame: one month
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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