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
hair thinning

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 18-100 years
Treatment RLY-1971
Clinical Study IdentifierNCT04252339
SponsorRelay Therapeutics, Inc.
Last Modified on19 February 2024

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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