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An early phase trial of RPTR-1-201 in Advanced Solid Tumors
EU CTIS ID: 2025-524010-28-00
What this study is testing
Phase 1: Evaluate the safety, tolerability, of RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody. Phase 2: Evaluate preliminary antitumor efficacy of RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. ≥ 18 years old on day of signing informed consent
- 2. HLA testing as confirmed by central review
- 3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment
- 4. Participants must have documented radiographic or symptomatic disease progression following receipt of prior standard-of-care therapy for advanced/metastatic disease, and must have no available treatment options that, in the judgment of the Investigator, would be expected to confer clinical benefit or survival advantage.
- 5. Participants must have received limited prior lines of systemic therapy for advanced or metastatic disease. Prior therapies must have included standard -of-care regimens if the participant was eligible to receive them, based on tumor type, molecular status, and clinical practice guidelines at the time of treatment.
- 6. At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
You likely can't join if
- 1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- 2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
- 3. Participant received systemic anti-cancer therapy or radiotherapy within 2 weeks prior to start of investigational product
- 4. Participant with a known additional malignancy that is progressing or has required active treatment in the last three years.
- 5. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized.
- 6. Administered a live vaccine ≤ 28 days before first dose of investigational product
See the full eligibility criteria
- 1. ≥ 18 years old on day of signing informed consent
- 2. HLA testing as confirmed by central review
- 3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment
- 4. Participants must have documented radiographic or symptomatic disease progression following receipt of prior standard-of-care therapy for advanced/metastatic disease, and must have no available treatment options that, in the judgment of the Investigator, would be expected to confer clinical benefit or survival advantage.
- 5. Participants must have received limited prior lines of systemic therapy for advanced or metastatic disease. Prior therapies must have included standard -of-care regimens if the participant was eligible to receive them, based on tumor type, molecular status, and clinical practice guidelines at the time of treatment.
- 6. At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
- 7. Adequate organ function as defined in the trial protocol
- 8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- 9. Willing and able to comply with contraceptive guidelines
- 1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- 2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
- 3. Participant received systemic anti-cancer therapy or radiotherapy within 2 weeks prior to start of investigational product
- 4. Participant with a known additional malignancy that is progressing or has required active treatment in the last three years.
- 5. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized.
- 6. Administered a live vaccine ≤ 28 days before first dose of investigational product
- 7. Concurrent participation in another therapeutic clinical trial
- 8. Any medical condition, including alcohol or drug abuse or dependence that would, in the Investigator’s or Sponsor’s assessment, prevent the participant’s participation due to safety concerns, compliance with trial procedure or interpretation of results.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.