Dose Escalation: Oral dose of RLY-1971 until Maximum Tolerated Dose (MTD), and Recommended Phase 2 dose (RP2D) are identified

Dose Expansion: Oral dose of RLY-1971 once Maximum Tolerated Dose (MTD), and Recommended Phase 2 Dose (RP2D) are identified.

RLY-1971

Clinical Trials

This study is a multi-center, open-label, dose escalation and expansion study of RLY-1971 in subjects with advanced or metastatic solid tumors.

Dose escalation/dose expansion study to assess the MTD, safety, tolerability, PK and preliminary anti-tumor activity of RLY-1971. Approximately 70 patients

RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

Phase 1, Open Label, Dose Escalation and Expansion Study of RLY-1971, a Highly Potent and Selective SHP2 Inhibitor, in Subjects With Advanced or Metastatic Solid Tumors

Blood will be collected at pre-dose at baseline on Cycle 1, Day 1 (C1D1) and at 3 time points (pre-dose, 2 hours post-dose, and 4 hours post-dose) on Cycle 1, Day 15 (C1D15) to assess the extent of target engagement

Blood will be collected at screening and at End of Treatment on all patients

DOR is defined as the time from the participant's initial objective response (CR or PR) to RLY-1971, to disease progression or death due to any cause, whichever occurs first

PFS is defined as the time from the start of study treatment to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first

MTD is defined as a dose level immediately below that at which ≥2 of 6 subjects experience a DLT during the first cycle.

RP2D may be the same dose level or lower than the determined MTD.

Blood samples may be taken at pre-dose, 0.5, 1, 2, 4, 6, and 8hrs on Cycle 1 Day 1 and 15, 24 hrs post dose on Cycle 1 Day 2, and pre-dose on Cycle 2 Day 1

Evaluation by RECIST 1.1; ORR is defined as the proportion of subjects in the response evaluable population who achieve the best overall response (BOR) of CR or PR

DCR is defined as the percentage of response evaluable subjects who achieve a BOR of CR, PR or SD for at least 3 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors	NCT04252339	Solid Tumor, Un...	RLY-1971	18 Years -	Hoffmann-La Roche
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors	NCT04252339	Solid Tumor, Un...	RLY-1971	18 Years -	Hoffmann-La Roche
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors	NCT04252339	Solid Tumor, Un...	RLY-1971	18 Years -	Hoffmann-La Roche

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