An early phase trial of RPTR-1-201 in Advanced Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Repertoire Immune Medicines Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

20 Mar 2026 → ongoing

Decision date (initial)

2026-03-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Repertoire Immune Medicines

External identifiers

EU CT number

2025-524010-28-00

ClinicalTrials.gov

NCT07293754

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Dose response, Pharmacokinetic, Safety

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.

Secondary objectives 5

1. All Phases: Further characterize the safety profile of RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
2. Phase 1: -Characterize pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibodies (ADAs) of RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
3. Phase 1: Evaluate preliminary antitumor activity of RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody
4. Phase 1b and 2: Evaluate progression-free survival (PFS) and time to response (TTR)
5. Phase 2: Evaluate overall survival (OS)

Conditions and MedDRA coding

Advanced Solid Tumor

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

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

Exclusion criteria 8

1. 1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
2. 2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
3. 3. Participant received systemic anti-cancer therapy or radiotherapy within 2 weeks prior to start of investigational product
4. 4. Participant with a known additional malignancy that is progressing or has required active treatment in the last three years.
5. 5. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized.
6. 6. Administered a live vaccine ≤ 28 days before first dose of investigational product
7. 7. Concurrent participation in another therapeutic clinical trial
8. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Phase 1: Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
2. 2. Phase 2: Objective Response Rate (ORR) per RECIST v1.1

Secondary endpoints 7

1. 1. All Phases: Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs)
2. 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
3. 3. Phase1: ORR and best overall response (BOR: CR, PR, stable disease [SD], or progressive disease [PD]) by RECIST v1.1 and iRECIST
4. 4. Phase 1: Duration of response (DOR) by RECIST v1.1 and iRECIST
5. 5. Phase 1: Disease control rate (CR+PR+SD)
6. 6. Phase 1 and 2: PFS and TTR by RECIST v1.1 and iRECIST
7. 7. Phase 2: Overall survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Repertoire Immune Medicines Inc.

Sponsor organisation

Repertoire Immune Medicines Inc.

Address

1 Kendall Square Building 1400w

City

Cambridge

Postcode

02139-1562

Country

United States

Scientific contact point

Organisation

Repertoire Immune Medicines Inc.

Contact name

Clinical Development Contact

Public contact point

Organisation

Repertoire Immune Medicines Inc.

Contact name

Clinical Development Contact

Third parties 17

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications