Clinical trial · Interventional
An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors
A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors
NCT07293754CI-TRIAL-00103344RaPTR-101recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 / PD-L1 monoclonal antibody | Drug | — | UNRESOLVED |
| RPTR-1-201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monotherapy
- description
- Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol.
- interventionNames
- Drug: RPTR-1-201
- type
- EXPERIMENTAL
- label
- Combination
- description
- 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.
- interventionNames
- Drug: RPTR-1-201
- Drug: PD-1 / PD-L1 monoclonal antibody
Primary outcomes (2)
- measure
- Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.