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NCT06463340 | RECRUITING | Advanced Solid Tumor

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

Schrödinger, Inc.

Brief 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.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

SGR-3515

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 52 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
Actual Study Start Date : 2024-06-18
Estimated Primary Completion Date : 2026-10-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • Study of SGR-3515 In Participants With Advanced Solid Tumors.

    Location Details

    NCT06463340

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Connecticut

    Yale University, Yale Cancer Center

    New Haven, Connecticut, United States, 06520

    RECRUITING

    United States, Road cancer

    Karmanos Cancer Institute

    Detroit, Road cancer, United States, 48201

    RECRUITING

    United States, New York

    Icahn School of Medicine at Mount Sinai

    New York, New York, United States, 10029

    RECRUITING

    United States, North Carolina

    Levine Cancer Institute

    Charlotte, North Carolina, United States, 28204

    RECRUITING

    United States, Ohio

    University of Cincinnati Medical Center

    Cincinnati, Ohio, United States, 45267

    RECRUITING

    United States, Oklahola

    Stephenson Cancer Center

    Ololama City, Okholohan, United States, 73104

    RECRUITING

    United States, Tennessee

    Sarah Cannon Research Institute

    Nashville, Tennessee, United States, 37203

    RECRUITING

    United States, Tennessee

    Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic

    Nashville, Tennessee, United States, 37232

    RECRUITING

    United States, Virginia

    NEXT Virginia

    Fairfax, Virginia, United States, 22031

    RECRUITING

    Canada, Ontario

    Princess Margaret Cancer Centre

    Toronto, Ontario, Canada, MSG 1X6