RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-18

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06463340

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
* 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Study Physician

CONTACT

+15032991150

sdgr-trials-group@schrodinger.com

Principal Investigator

Margaret Dugan, MD

STUDY_DIRECTOR

CMO/Study Physician

Study Locations (Sites)

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Schrödinger, Inc.

Margaret Dugan, MD, STUDY_DIRECTOR, CMO/Study Physician

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-18

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-06-18

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Solid Tumor
Advanced Solid Tumor

Additional Relevant MeSH Terms

Advanced Solid Tumor