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

March 25, 2026 updated by: Recurv Pharma Inc

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12mg of RP-001
The study will begin with 12mg of RP-001.
Drug: RP-001
A new class of Taxane.
Experimental: 25mg of RP-001
Dose level 2 will be 25mg as determined by safety.
Drug: RP-001
A new class of Taxane.
Experimental: 75mg of RP-001
Dose level 3 will be 75mg of RP-001 as determined by safety
Drug: RP-001
A new class of Taxane.
Experimental: 150mg of RP-001
Dose level 4 will be 150mg of RP-001 as determined by safety.
Drug: RP-001
A new class of Taxane.
Experimental: 250mg of RP-001
Dose level 5 will be 250mg as determined by safety.
Drug: RP-001
A new class of Taxane.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the recommended Phase 2 dose
Time Frame: one month
Determination of maximum tolerated dose level
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recurv Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 23, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-001-01
  • 2025-520668-16-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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