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
2 other identifiers
interventional
66
0 countries
N/A
Brief Summary
Phase 1/2a Study of RP-001 in participants with Advanced Malignancies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2026
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 31, 2026
March 1, 2026
1.6 years
March 21, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 month
Secondary Outcomes (1)
To determine the recommended Phase 2 dose
one month
Study Arms (5)
12mg of RP-001
EXPERIMENTALThe study will begin with 12mg of RP-001.
25mg of RP-001
EXPERIMENTALDose level 2 will be 25mg as determined by safety.
75mg of RP-001
EXPERIMENTALDose level 3 will be 75mg of RP-001 as determined by safety
150mg of RP-001
EXPERIMENTALDose level 4 will be 150mg of RP-001 as determined by safety.
250mg of RP-001
EXPERIMENTALDose level 5 will be 250mg as determined by safety.
Interventions
A new class of Taxane.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. Active infection requiring systemic anti-infective therapy within 28 days prior to first dose of RP-001.
- \. 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.
- \. Concurrent systemic anti-cancer therapy other than luteinizing hormone-releasing hormone (LH-RH) agonists.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2026
First Posted
March 31, 2026
Study Start
April 23, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
March 31, 2026
Record last verified: 2026-03