Overview

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

Eligibility

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