Clinical Trials /

RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

NCT04252339

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors
  • Official Title: A Phase 1, Open Label, Dose Escalation Study of RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: RLY-1971-101
  • SECONDARY ID: REFMAL 678
  • NCT ID: NCT04252339

Conditions

  • Solid Tumor, Unspecified, Adult

Interventions

DrugSynonymsArms
RLY-1971RLY-1971 - Dose Escalation/Expansion

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
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.
  • RLY-1971

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD)
Time Frame:Escalation Phase - 18 month Enrollment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Plasma concentration levels of RLY-1971
Time Frame:At the beginning of Cycle 1 & Cycle 2 (Each Cycle is 21 days)
Safety Issue:
Description: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
Measure:Objective Response Rate (ORR)
Time Frame:Through study completion (an average of one year)
Safety Issue:
Description: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
Measure:Disease Control Rate (DCR)
Time Frame:Through study completion (an average of one year)
Safety Issue:
Description:DCR is defined as the percentage of response evaluable subjects who achieve a BOR of CR, PR or SD for at least 3 months

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Relay Therapeutics, Inc.

Trial Keywords

  • Solid Tumors
  • Advanced or Metastatic Solid Tumors
  • Phase 1
  • First in Human (FIH)
  • SHP2 inhibition
  • PTPN11
  • Bypass Resistance

Last Updated

February 5, 2020