A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors

Conditions

Advanced Solid Tumor

Brief summary

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

Detailed description

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. 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. Phase1: ORR and best overall response (BOR: CR, PR, stable disease [SD], or progressive disease [PD]) by RECIST v1.1 and iRECIST, 4. Phase 1: Duration of response (DOR) by RECIST v1.1 and iRECIST, 5. Phase 1: Disease control rate (CR+PR+SD), 6. Phase 1 and 2: PFS and TTR by RECIST v1.1 and iRECIST, 7. Phase 2: Overall survival (OS)

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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. 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. Phase1: ORR and best overall response (BOR: CR, PR, stable disease [SD], or progressive disease [PD]) by RECIST v1.1 and iRECIST, 4. Phase 1: Duration of response (DOR) by RECIST v1.1 and iRECIST, 5. Phase 1: Disease control rate (CR+PR+SD), 6. Phase 1 and 2: PFS and TTR by RECIST v1.1 and iRECIST, 7. Phase 2: Overall survival (OS)	—

Measure

Time frame

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. 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. Phase1: ORR and best overall response (BOR: CR, PR, stable disease [SD], or progressive disease [PD]) by RECIST v1.1 and iRECIST, 4. Phase 1: Duration of response (DOR) by RECIST v1.1 and iRECIST, 5. Phase 1: Disease control rate (CR+PR+SD), 6. Phase 1 and 2: PFS and TTR by RECIST v1.1 and iRECIST, 7. Phase 2: Overall survival (OS)

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Outcome results

None listed