Advanced MalignanciesPhase 1/2NCT07504263
Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies
A Phase 1/2 study testing RP-001 in people with Advanced Malignancies and Oncology, run by Recurv Pharma Inc.
Trial summary
Phase 1/2a Study of RP-001 in participants with Advanced Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Oncology, Colorectal Cancer
- What is being tested?
- RP-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2026to 1 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Active infection requiring systemic anti-infective therapy within 28 days prior to first dose of RP-001.
- 2. Cardiovascular disease, including:
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Phase 1/2a Study of RP-001 in participants with Advanced Malignancies
Read the 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
- Conditions
- Advanced Malignancies, Oncology, Colorectal Cancer, Pancreatic Cancer, Cancer
- Being tested
- RP-001
- Keywords
- advanced malignancies, colorectal cancer, pancreatic ductal adenocarcinoma
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP-001Drug
A new class of Taxane.
| Study group | Role | What they receive |
|---|---|---|
| 12mg of RP-001 | Experimental | The study will begin with 12mg of RP-001. Receives: Drug: RP-001 |
| 25mg of RP-001 | Experimental | Dose level 2 will be 25mg as determined by safety. Receives: Drug: RP-001 |
| 75mg of RP-001 | Experimental | Dose level 3 will be 75mg of RP-001 as determined by safety Receives: Drug: RP-001 |
| 150mg of RP-001 | Experimental | Dose level 4 will be 150mg of RP-001 as determined by safety. Receives: Drug: RP-001 |
| 250mg of RP-001 | Experimental | Dose level 5 will be 250mg as determined by safety. Receives: Drug: RP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
To determine the recommended Phase 2 dose
Determination of maximum tolerated dose level
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start23 Apr 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recurv Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504263
- Sponsor's protocol ID
- RP-001-01
- Other IDs
- 2025-520668-16-00, 2025
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07504263
- Acronym / sponsor ID
- RP-001-01
- Conditions
- Advanced Malignancies, Oncology, Colorectal Cancer, Pancreatic Cancer, Cancer
- Keywords
- advanced malignancies, colorectal cancer, pancreatic ductal adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Recurv Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 12mg of RP-001 | Experimental | Drug: RP-001The study will begin with 12mg of RP-001. |
| 25mg of RP-001 | Experimental | Drug: RP-001Dose level 2 will be 25mg as determined by safety. |
| 75mg of RP-001 | Experimental | Drug: RP-001Dose level 3 will be 75mg of RP-001 as determined by safety |
| 150mg of RP-001 | Experimental | Drug: RP-001Dose level 4 will be 150mg of RP-001 as determined by safety. |
| 250mg of RP-001 | Experimental | Drug: RP-001Dose level 5 will be 250mg as determined by safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (5 listed)
- 1. Active infection requiring systemic anti-infective therapy within 28 days prior to first dose of RP-001.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP-001A new class of Taxane. | Drug | 12mg of RP-001, 150mg of RP-001, 250mg of RP-001, 25mg of RP-001, 75mg of RP-001 |
Primary outcome
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 secondary outcome
To determine the recommended Phase 2 dose
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RP-001 in people with Advanced Malignancies and Oncology, run by Recurv Pharma Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer W Curry, PharmD (+1-317-726-9118, jennifer.curry@recurvpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the safety and tolerability of RP-001 administered as monotherapy. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.