RPTR-1-201 for Advanced solid tumor

Inclusion criteria

• {"criterion_text":"- 1. ≥ 18 years old on day of signing informed consent\n- 2. HLA testing as confirmed by central review\n- 3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment\n- 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.\n- 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.\n- 6. At least one measurable lesion per RECIST v1.1 as assessed by the investigator.\n- 7. Adequate organ function as defined in the trial protocol\n- 8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1\n- 9. Willing and able to comply with contraceptive guidelines"}

Exclusion criteria

• {"criterion_text":"- 1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n- 2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).\n- 3. Participant received systemic anti-cancer therapy or radiotherapy within 2 weeks prior to start of investigational product\n- 4. Participant with a known additional malignancy that is progressing or has required active treatment in the last three years.\n- 5. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized.\n- 6. Administered a live vaccine ≤ 28 days before first dose of investigational product\n- 7. Concurrent participation in another therapeutic clinical trial\n- 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."}

Primary endpoints

• {"endpoint_text":"- 1. Phase 1: Number of participants with dose-limiting toxicities and treatment-emergent adverse events.","definition_or_measurement_approach":"Count of participants with dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) during Phase 1"}
• {"endpoint_text":"- 2. Phase 2: Objective Response Rate (ORR) per RECIST v1.1","definition_or_measurement_approach":"Objective Response Rate measured per RECIST v1.1"}

Secondary endpoints

• {"endpoint_text":"- 1. All Phases: Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs)","definition_or_measurement_approach":"Incidence and severity grading of adverse events and abnormal safety assessments (laboratory tests, ECGs, vital signs)"}
• {"endpoint_text":"- 2. Phase1: Characterization of the pharmacokinetic profile of RPTR-1-201 (for example, maximum observed concentration and exposure over time), initial pharmacodynamics, and incidence of anti-drug antibodies","definition_or_measurement_approach":"PK parameters (e.g., Cmax, exposure over time), PD measurements, and incidence of anti-drug antibodies"}
• {"endpoint_text":"- 3. Phase1: ORR and best overall response (BOR: CR, PR, stable disease [SD], or progressive disease [PD]) by RECIST v1.1 and iRECIST","definition_or_measurement_approach":"ORR and BOR classification per RECIST v1.1 and iRECIST"}
• {"endpoint_text":"- 4. Phase 1: Duration of response (DOR) by RECIST v1.1 and iRECIST","definition_or_measurement_approach":"Duration from first documented response to progression or death per RECIST v1.1 and iRECIST"}
• {"endpoint_text":"- 5. Phase 1: Disease control rate (CR+PR+SD)","definition_or_measurement_approach":"Proportion of participants achieving CR, PR, or SD"}
• {"endpoint_text":"- 6. Phase 1 and 2: PFS and TTR by RECIST v1.1 and iRECIST","definition_or_measurement_approach":"Progression-free survival and time to response assessed per RECIST v1.1 and iRECIST"}
• {"endpoint_text":"- 7. Phase 2: Overall survival (OS)","definition_or_measurement_approach":"Time from randomization/enrollment (as defined in protocol) to death from any cause"}

Spain

Earliest CTIS Part Ii Submission Date

26-01-2026

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

50

Number Of Sites

8

Number Of Participants

52

Primary sponsor

Full Name

Repertoire Immune Medicines Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Precision for Medicine (HU) Kft.

Responsibilities

Feasibility, Site Contract, Study Start-Up, Clinical Operations, Consulting services for Medical; Remote monitoring, e-TMF; regulatory support

Name

Precision For Medicine Inc.

Responsibilities

Sample storage, Sample Isolation/Processing, Kit Production, Sample Testing, repository services

Name

Almac Clinical Services Limited

Responsibilities

Drug warehouse, labeling (if required) and supply to all countries

Third parties

• {"country":"United States","full_name":"Immunologix","duties_or_roles":"sponsorDuties codes: [4]; contact email: asullivan@immunologixlabs.com","organisation_type":"Health care"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: Treeves@guardanthealth.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"DLRC Limited","duties_or_roles":"sponsorDuties codes: [12]; contact email: abhay.patil@dlrcgroup.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Translation Services; contact email: cerdman@transperfect.com","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"Precision for Medicine (HU) Kft.","duties_or_roles":"sponsorDuties codes: [1,10,11,12,15,15,2,5,6,7,8]; values include: Feasibility, Site Contract, Study Start-Up, Clinical Operations, Consulting services for Medical; Remote monitoring, e-TMF; contact email: RegulatoryEU@precisionformedicine.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Sample Storage Sample Isolation/Processing Kit Production Sample Testing; contact email: repositoryservices.mailbox@precisionformedicine.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Tissue Testing; contact email: Halit.kolenovic@neogenomics.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Precision For Medicine Inc. (Houston repository)","duties_or_roles":"sponsorDuties codes: [15]; value: sample storage, sample testing, Sample Isolation/Processing; contact email: Repository.Houston@precisionformedicine.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labconnect LLC","duties_or_roles":"sponsorDuties codes: [4]; contact email: jcarter@labconnect.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Atrys Health S.A.","duties_or_roles":"sponsorDuties codes: [4]; contact email: P4m@atyrshealth.com","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Certara USA Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: PK/PD modeling; contact email: Stacy.carbaugh@certara.com","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"sponsorDuties codes: [15]; value: Sample Storage, Sample Isolation/Processing, Kit Production, Sample Testing; contact email: repository.berlin@precisionformedicine.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact email: Vanessa.BATISTA@3ds.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Versiti Wisconsin Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: Manderson@versiti.org","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Labor Dr. Wisplinghoff GbR","duties_or_roles":"sponsorDuties codes: [4]; contact email: Dr.D.Hoffmann@gmx.net","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Greens Ltd","duties_or_roles":"sponsorDuties codes: [15]; value: Site binder; contact email: adam.branaghan@greensdigital.com","organisation_type":"Industry"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: [15]; value: Drug warehouse, labeling (if required) and supply to all countries; contact email: laketta.boldin@almacgroup.com","organisation_type":"Pharmaceutical company"}