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RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252339
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Relay Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Solid Tumor, Unspecified, Adult Drug: RLY-1971 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Dose Escalation Study of RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors
Estimated Study Start Date : January 27, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: RLY-1971 - Dose Escalation/Expansion

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.

Drug: RLY-1971
RLY-1971 is an oral inhibitor of SHP2.




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Escalation Phase - 18 month Enrollment ]
  2. Recommended Phase 2 Dose (RP2D) [ Time Frame: Escalation Phase - 18 month Enrollment ]

Secondary Outcome Measures :
  1. Plasma concentration levels of RLY-1971 [ Time Frame: At the beginning of Cycle 1 & Cycle 2 (Each Cycle is 21 days) ]
    Blood samples may be taken at pre-dose, 0.5, 1, 2, 4, 6, and 8hrs on Cycle I Day 1 and 15, 24 hrs post dose on Cycle 1 Day 2, 48hrs post dose on Cycle 1 Day 3, and post dose on Cycle 2 Day 1

  2. Objective Response Rate (ORR) [ Time Frame: Through study completion (an average of one year) ]
    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

  3. Disease Control Rate (DCR) [ Time Frame: Through study completion (an average of one year) ]
    DCR is defined as the percentage of response evaluable subjects who achieve a BOR of CR, PR or SD for at least 3 months


Other Outcome Measures:
  1. Changes in phospho-ERK levels [ Time Frame: At the beginning of Cycle 1 Day 1 post and pre ]
    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.

  2. Tumor mutations by sequencing circulating tumor DNA (ctDNA) [ Time Frame: At the beginning of Cycle 1 Day 1 ]
    Blood will be collected at screening and at End of Treatment on all patients

  3. Duration of Response (DOR) [ Time Frame: Through study completion (an average of one year) ]
    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

  4. Time to Response (TTR) [ Time Frame: Through study completion (an average of one year) ]
    TTR is defined as the period of time from the date of first the dose of RLY-1971 administration until the first objective documentation of response.

  5. Time to Progression (TTP) [ Time Frame: Through study completion (an average of one year) ]
    TTP is defined as the interval between the first dose of RLY-1971 until disease progression

  6. Progression-free Survival (PFS). [ Time Frame: Through study completion (an average of one year) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures
  2. Subject is a male or female subject ≥18 years of age at the time of consent
  3. Subject must have an ECOG PS ≤ 1
  4. Subject must have histologically or cytologically confirmed advanced or metastatic solid tumor
  5. There is no available standard systemic treatment for the subject's tumor histology and/or molecular biomarker profile
  6. Subject must have radiographically measurable or evaluable disease
  7. Subject must have recovered from the reversible effects of prior anti-neoplastic therapy, except for alopecia and ≤ grade 2 neuropathy.
  8. Subject has adequate end organ function
  9. Subject is willing to comply with all protocol-required visits, assessments, and procedures
  10. 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:

  1. Subjects with documented history of tumor mutations that may not be amenable to treatment with RLY-1971, including

    1. KRAS mutations: G12D, G12V, G13X, and Q61X
    2. BRAF V600E mutation
    3. MEK mutations
  2. Subjects with prior antineoplastic therapy within 3 weeks of Study Day 1, or 5 half-lives, whichever is shorter
  3. Subjects with prior palliative radiotherapy within 1 week of Study Day 1
  4. Subjects who have had major surgery or trauma, or incomplete recovery from surgery or trauma, within 4 weeks of Study Day 1
  5. 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
  6. Subjects with a history or evidence of ophthalmic disease
  7. Subjects with a history or evidence of significant cardiac dysfunction
  8. Subjects with a history or evidence of significant gastrointestinal disease
  9. Subjects with other serious concurrent medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252339


Contacts
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Contact: Ben Wolf, MD, PhD 617-370-8837 ClinicalOperations@relaytx.com
Contact: Fatou N'Dure 617-370-8837 ClinicalOperations@relaytx.com

Locations
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United States, Florida
SCRI-Sarasota/Florida Cancer Specialists Not yet recruiting
Sarasota, Florida, United States, 34232
Contact: Judy Wang, MD    941-377-9993      
United States, Massachusetts
Dana Farber Cancer Center Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jessica Lin, MD    617-724-4000      
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jessica Lin, MD    617-724-4000      
United States, Tennessee
SCRI-Nashville/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Joanna Bendell, MD    615-320-5090      
Principal Investigator: Joanna Bendell, MD         
Sponsors and Collaborators
Relay Therapeutics, Inc.
Investigators
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Study Chair: Joanna Bendell, MD SCRI-Tennessee Oncology
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Responsible Party: Relay Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04252339    
Other Study ID Numbers: RLY-1971-101
REFMAL 678 ( Other Identifier: Sarah Cannon Development Innovations )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Relay Therapeutics, Inc.:
Solid Tumors
Advanced or Metastatic Solid Tumors
Phase 1
First in Human (FIH)
SHP2 inhibition
PTPN11
Bypass Resistance
Additional relevant MeSH terms:
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Neoplasms