Study of SGR-3515 In Participants With Advanced Solid Tumors.

Schrödinger, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: SGR-3515

Study type

Interventional

Funder types

Industry

Identifiers

NCT06463340

SGR-3515-101

Details and patient eligibility

About

The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.

Full description

SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Diagnosis of advanced/metastatic solid tumor
Measurable disease per RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
Adequate bone marrow and organ function
Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug

Exclusion Criteria

Participants with primary Central Nervous System (CNS tumors).
Participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
Participant who has received definitive local control radiation (any dose greater than 50 Gy) < 42 days prior to the first dose of study drug.
Participant who has received major surgeries ≤ 21 days prior to first dose of study drug
Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
Participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose