Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies

NCT07504263 — Phase 1 / Phase 2, Not yet recruiting, 66 participants, Recurv Pharma Inc

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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

Registry	NCT07504263
Status	Not yet recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	66 (Estimated)
Sponsor	Recurv Pharma Inc (Industry)
Conditions	Advanced Malignancies, Oncology, Colorectal Cancer, Pancreatic Cancer, Cancer
Interventions	RP-001 (Drug)
Dates	start 2026-04-23 (estimated), primary completion 2027-12-01 (estimated), completion 2028-04-01 (estimated), first posted 2026-03-31, last updated 2026-03-31

-Summary

Phase 1/2a Study of RP-001 in participants with Advanced Malignancies

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
12mg of RP-001	Experimental	Drug: RP-001	The study will begin with 12mg of RP-001.
25mg of RP-001	Experimental	Drug: RP-001	Dose level 2 will be 25mg as determined by safety.
75mg of RP-001	Experimental	Drug: RP-001	Dose level 3 will be 75mg of RP-001 as determined by safety
150mg of RP-001	Experimental	Drug: RP-001	Dose level 4 will be 150mg of RP-001 as determined by safety.
250mg of RP-001	Experimental	Drug: RP-001	Dose level 5 will be 250mg as determined by safety.

RP-001 (Drug): A new class of Taxane.

+Outcome measures

Primary outcomes

To characterize the safety and tolerability of RP-001 administered as monotherapy. [1 month]: • Dose limiting toxicities (DLTs) and adverse events (AEs) using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v5.0

Secondary outcomes

To determine the recommended Phase 2 dose [one month]: Determination of maximum tolerated dose level

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Funding

NIH grants: 2025