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Trial Title:
Study of SGR-3515 In Participants With Advanced Solid Tumors.
NCT ID:
NCT06463340
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumor
Advanced Solid Tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SGR-3515
Description:
SGR-3515 will be administered orally with an intermittent schedule.
Arm group label:
Dose Escalation
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, 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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Deborah Doroshow, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Vivek Subbiah, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mohamad A Salkeni, MD
Email:
Principal Investigator
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
MSG 1X6
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Stephanie Lheureux, MD
Email:
Principal Investigator
Start date:
June 18, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Schrödinger, Inc.
Agency class:
Industry
Source:
Schrödinger, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06463340
