Description:
This study is a multi-center, open-label, dose escalation study of RLY-1971 in subjects with
advanced or metastatic solid tumors.
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
Drug | Synonyms | Arms |
---|
RLY-1971 | | RLY-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
Name | Type | Description | Interventions |
---|
RLY-1971 - Dose Escalation/Expansion | Experimental | 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. | |
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