RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

STATUS

Recruiting
participants needed

52
sponsor

Relay Therapeutics, Inc.

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Updated on 19 February 2024

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solid tumour

solid tumor

neuropathy

metastatic malignant solid tumor

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Summary

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

Description

Dose escalation/dose expansion study to assess the MTD, safety, tolerability, PK and preliminary anti-tumor activity of RLY-1971. Approximately 50 patients.

Details

Condition	Solid Tumor, Unspecified, Adult
Age	18years - 100years
Treatment	RLY-1971
Clinical Study Identifier	NCT04252339
Sponsor	Relay Therapeutics, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 or cytologically confirmed advanced or metastatic solid tumor
	There is no available standard systemic treatment for the subject's tumor histology and/or molecular biomarker profile
	Subject must have radiographically measurable or evaluable disease
	Subject must have recovered from the reversible effects of prior anti-neoplastic therapy, except for alopecia and grade 2 neuropathy
	Subject has adequate end organ function
	Subject is willing to comply with all protocol-required visits, assessments, and procedures
	Male and female subjects of child-bearing potential are willing to use medically acceptable methods of birth control from the screening visit through 30 days after the last dose of study medication
Exclusion Criteria
	Subjects with documented history of tumor mutations that may not be amenable to treatment with RLY-1971, including
	KRAS mutations: G12D, G12V, G13X, and Q61X
	BRAF V600E mutation
	MEK mutations
	Subjects with prior antineoplastic therapy within 3 weeks of Study Day 1, or 5 half-lives, whichever is shorter
	Subjects with prior palliative radiotherapy within 1 week of Study Day 1
	Subjects who have had major surgery or trauma, or incomplete recovery from surgery or trauma, within 4 weeks of Study Day 1
	Subjects with known central nervous system (CNS) primary tumor, uncontrolled CNS metastases, or carcinomatous meningitis. Subjects with stable or asymptomatic brain metastases are eligible to participate
	Subjects with a history or evidence of ophthalmic disease
	Subjects with a history or evidence of significant cardiac dysfunction
	Subjects with a history or evidence of significant gastrointestinal disease
	Subjects with other serious concurrent medical conditions

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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Study Definition

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RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors