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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463340
• Other study ID #: SGR-3515-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 24, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Schrödinger, Inc.
• Contact: Study Physician
• Phone: +15032991150
• Email: sdgr-trials-group[@]schrodinger.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

SGR-3515-101 is a phase 1, fist-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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SGR-3515
SGR-3515 will be administered orally with an intermittent schedule.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Schrödinger, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AEs)	Incidence and severity of adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs); and dose interruptions, dose reductions, dose delays and study drug discontinuation due to AEs.	Day 1 to 28 days after the last dose of SGR-3515.
Primary	Incidence of Dose Limiting Toxicities (DLTs)	Incidence of Dose Limiting Toxicities (DLTs)	Day 1 to Day 28 of the first 28-day dosing cycle.
Primary	Incidence of serious adverse events (SAEs)	Incidence of serious adverse events (SAEs)	Day 1 to 28 days after the last dose of SGR-3515
Primary	Recommended phase 2 dose and schedule	Recommended phase 2 dose and schedule	From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.
Secondary	Pharmacokinetics: Measures Cmax and Cmin of SGR-3515	Pharmacokinetics: Cmax and Cmin of SGR-3515	Day 1 to Day 28 of first 28-day dosing cycle
Secondary	Pharmacokinetics Measures: t1/2 of SGR-3515	Pharmacokinetics: t1/2 of SGR-3515	Day 1 to Day 28 of first 28-day dosing cycle
Secondary	Pharmacokinetics Measures: tmax of SGR-3515	Pharmacokinetics: tmax of SGR-3515	Day 1 to Day 28 of first 28-day dosing cycle
Secondary	Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515	Pharmacokinetics: Area Under the Curve (AUC) of SGR-3515	Day 1 to Day 28 of first 28-day dosing cycle
Secondary	Efficacy analysis	Efficacy analysis will be performed for each dose level and include but not limited to objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and duration of disease control (DDC), which will be assessed by investigators	Day 1 to end of Phase I study