Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RP-001.
- Who it may be relevant to
- Registry conditions: Advanced Malignancies, Oncology, Colorectal Cancer, Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
Phase 1/2a Study of RP-001 in participants with Advanced Malignancies
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
Interventions
- Drug RP-001
A new class of Taxane.
Primary outcome measures
- To characterize the safety and tolerability of RP-001 administered as monotherapy. [Time frame: 1 month]
Secondary outcome measures (1)
- To determine the recommended Phase 2 dose [Time frame: one month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07504263 · RP-001-01 · 2025-520668-16-00