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RLY-1971

Phase 1

Solid Tumor, Unspecified, Adult | Small molecule | Oncology |Roche Holding AG|Last Updated: Jan 31, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

RLY-1971 · 1 trial · 1 indication

Phase 1 1
NCT04252339RLY-1971 in Subjects With Advanced or Metastatic Solid TumorsSolid Tumor, Unspecified, Adult
COMPLETED56 Analytics
PHASE1COMPLETED
RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors
Solid Tumor, Unspecified, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD)
Escalation Phase - 18 month Enrollment

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

Recommended Phase 2 Dose (RP2D)
Escalation Phase - 18 month Enrollment

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

Secondary Endpoints

Plasma concentration levels of RLY-1971
At the beginning of Cycle 1 & Cycle 2 (Each Cycle is 21 days)
Objective Response Rate (ORR)
Through study completion (an average of one year)
Disease Control Rate (DCR)
Through study completion (an average of one year)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RLY-1971 - Dose Escalation/ExpansionEXPERIMENTALDose 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.

Interventions

NameTypeDescription
RLY-1971DRUGRLY-1971 is an oral inhibitor of SHP2.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Subject is willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures Subject is a male or female subject ≥18 years of age at the time of consent Subject must have an ECOG PS ≤ 1 Subject must have histologically o...

Countries:United States
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Frequently asked questions about RLY-1971

What is RLY-1971 used for?

RLY-1971 is an investigational small molecule being studied for the treatment of solid tumors in adults. It is intended for patients with advanced or metastatic solid tumors, as evaluated in a Phase 1 clinical trial.

Who makes RLY-1971?

RLY-1971 is being developed by Roche Holding AG, a biopharmaceutical company. The company's stock is traded under the ticker symbol RHHBY.

What phase is RLY-1971 in?

RLY-1971 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is RLY-1971 in?

RLY-1971 has been studied in a Phase 1 clinical trial with the identifier NCT04252339. This trial, titled "RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors," enrolled 56 participants in the United States and has been completed.

Is RLY-1971 the same as any other drug?

No alternative names for RLY-1971 have been reported. It is known solely by its code name RLY-1971 in clinical development.