NCT06463340

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

A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Schrödinger, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SGR-3515	SGR-3515 will be administered orally with an intermittent schedule.

Timeline

• Start date: 2024-06-18
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2024-06-17
• Last updated: 2025-08-01

Locations

14 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study