Advanced Malignant Solid TumorPhase 1/2RaPTR-101NCT07293754
An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors
A Phase 1/2 study testing RPTR-1-201 and PD-1 / PD-L1 monoclonal antibody in people with Advanced Malignant Solid Tumor, run by Repertoire Immune Medicines at 12 sites in 4 countries.
Trial summary
This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- RPTR-1-201 and PD-1 / PD-L1 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 12 Dec 2025to 15 Apr 2029
- 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
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
- At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function as defined in the trial protocol.
- Ability to provide written informed consent and comply with trial procedures.
Who cannot join
- History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
- Known active leptomeningeal disease or uncontrolled central nervous system metastases.
- Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
- Prior allogenic organ transplantation
- Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.
- Other protocol-defined inclusion and exclusion criteria apply
Trial locations and contacts
12 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 4 countries
Spain7 sites, 7 recruiting
- Recruiting
START Barcelona
Barcelona
Monica Alemany, 34 932 54 50 30 ext. 7988, monica.alemany@start-barcelona.com
- Recruiting
START Rioja
Logroño
Manuel Vaz Herencia, +34941056827, Manuel.Vaz@startrioja.com
- Recruiting
Clinica Universidad de Navarra - Madrid
Madrid
Pilar Nuñez, +34 91 353 19 20, eecc@unav.es
- Recruiting
START Madrid-CIOCC
Madrid
Javier Arnau, (+34) 913 96 41 30, Javier.Arnau@startmadrid.com
Dalmazio Danini, (+34) 917 56 78 25, dalmazio.danini@startmadrid.com
- Recruiting
START Madrid-FJD
Madrid
Paloma Delgado, 0034 913 96 41 20, paloma.delgado@startmadrid.com
- Recruiting
Clinica Universidad de Navarra - Pamplona
Pamplona
Pilar Nuñez, +34 948 255 400, eecc@unav.es
- Recruiting
INCLIVA Instituto de Investigación Sanitaria VLC
Valencia
María Burgos Guerra, +34 961 973 500, mburgos@incliva.es
United States3 sites, 3 recruiting
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Jacob Goldberg, 616-954-5561, jacob.goldberg@startresearch.com
- Recruiting
START New York-Long Island
Lake Success, New York, 11042
Sadia Morium, 363-207-5160, sadia.morium@startresearch.com
- Recruiting
START San Antonio
San Antonio, Texas, 78229
Danielle Gillen, 726.215.6915, danielle.gillen@startresearch.com
Ireland1 site, 1 recruiting
- Recruiting
START Dublin
Dublin
Amy Slater, +353 1 854 5946, amy.slater@startdublin.com
Portugal1 site, 1 recruiting
- Recruiting
START Lisbon
Lisbon
Patrícia Alves, +351 926 336 629, startupeu@startresearch.com
About this study
Official title: A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors
This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- RPTR-1-201, PD-1 / PD-L1 monoclonal antibody
- Keywords
- advanced cancer, solid tumors, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPTR-1-201Drug
RPTR-1-201
PD-1 / PD-L1 monoclonal antibodyDrug
PD-1/PD-L1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol. Receives: Drug: RPTR-1-201 |
| Combination | Experimental | Participants receive RPTR-1-201 in combination with an approved or investigational PD-1 monoclonal antibody at doses and schedules defined by the trial protocol. Receives: Drug: RPTR-1-201; Drug: PD-1 / PD-L1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0.
Measured: From first dose through 30 days after last dose of trial treatment.
Objective Response Rate (ORR) per RECIST v1.1
Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.
Measured: From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
Secondary outcomes (7)
Incidence and severity of adverse events and abnormal safety assessments.
Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs).
Measured: From first dose through 30 days after last dose of trial treatment
Pharmacokinetics of RPTR-1-201
Characterization of the pharmacokinetic maximum observed concentration of RPTR-1-201.
Measured: First dose until end of treatment (assessed up to 24 months).
Progression Free Survival (PFS)
Time from first dose of RPTR-1-201 to the earliest date of documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Overall survival (OS)
Time from first dose of RPTR-1-201 to death from any cause.
Measured: From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
Time to Response
Time from first dose of RPTR-1-201 to the first documented complete response or partial response per RECIST v1.1.
Measured: From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Pharmacokinetics of RPTR-1-201 (AUC)
Characterization of the pharmacokinetic area under the curve of RPTR-1-201
Measured: First dose until end of treatment (assessed up to 24 months)
Immunogenicity of RPTR-1-201
Characterization of the incidence of anti-drug antibodies of RPTR-1-201.
Measured: First dose until end of treatment (assessed up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start12 Dec 2025
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repertoire Immune Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293754
- Sponsor's protocol ID
- RPTR-1-201-101
- Other IDs
- 2025-524010-28-00, 2025
- Acronym
- RaPTR-101
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared for this trial.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07293754
- Acronym / sponsor ID
- RaPTR-101 / RPTR-1-201-101
- Conditions
- Advanced Malignant Solid Tumor
- Keywords
- advanced cancer, solid tumors, immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Repertoire Immune MedicinesIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 19 Dec 2025 (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.
This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: RPTR-1-201Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol. |
| Combination | Experimental | Drug: RPTR-1-201, Drug: PD-1 / PD-L1 monoclonal antibodyParticipants receive RPTR-1-201 in combination with an approved or investigational PD-1 monoclonal antibody at doses and schedules defined by the trial protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
- At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function as defined in the trial protocol.
- Ability to provide written informed consent and comply with trial procedures.
Key exclusion criteria (6 listed)
- History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
- Known active leptomeningeal disease or uncontrolled central nervous system metastases.
- Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
- Prior allogenic organ transplantation
- Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.
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 |
|---|---|---|
| RPTR-1-201RPTR-1-201 | Drug | Combination, Monotherapy |
| PD-1 / PD-L1 monoclonal antibodyPD-1/PD-L1 monoclonal antibody | Drug | Combination |
Primary outcome
Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
Time frame: From first dose through 30 days after last dose of trial treatment.
Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0.
Objective Response Rate (ORR) per RECIST v1.1
Time frame: From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.
7 secondary outcomes
Incidence and severity of adverse events and abnormal safety assessments.
Time frame: From first dose through 30 days after last dose of trial treatment
Pharmacokinetics of RPTR-1-201
Time frame: First dose until end of treatment (assessed up to 24 months).
Progression Free Survival (PFS)
Time frame: From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Overall survival (OS)
Time frame: From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
Time to Response
Time frame: From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Pharmacokinetics of RPTR-1-201 (AUC)
Time frame: First dose until end of treatment (assessed up to 24 months)
Immunogenicity of RPTR-1-201
Time frame: First dose until end of treatment (assessed up to 24 months)
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 28 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared for this trial.
Related trials for Advanced Malignant Solid Tumor
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingObservational study
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
Advanced Solid Tumor
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RPTR-1-201 and PD-1 / PD-L1 monoclonal antibody in people with Advanced Malignant Solid Tumor, run by Repertoire Immune Medicines at 12 sites in 4 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, United States, Ireland, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicities and treatment-emergent adverse events. (time frame: From first dose through 30 days after last dose of trial treatment.). The study lists 2 primary outcomes in all. 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 28 Sep 2026.