Clinical trial NCT06463340: Study of SGR-3515 In Participants With Advanced Solid Tumors.
Official title: A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Solid Tumor
Advanced Solid Tumor
Lead sponsor: Schrödinger, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: Day 1 to 28 days after the last dose of SGR-3515.
measure: Incidence of Dose Limiting Toxicities (DLTs)
timeFrame: Day 1 to Day 28 of the first 28-day dosing cycle.
measure: Incidence of serious adverse events (SAEs)
timeFrame: Day 1 to 28 days after the last dose of SGR-3515
measure: Recommended phase 2 dose and schedule
timeFrame: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.
Secondary outcomes:
measure: Pharmacokinetics: Measures Cmax and Cmin of SGR-3515
timeFrame: Day 1 to Day 28 of first 28-day dosing cycle
measure: Pharmacokinetics Measures: t1/2 of SGR-3515
timeFrame: Day 1 to Day 28 of first 28-day dosing cycle
measure: Pharmacokinetics Measures: tmax of SGR-3515
timeFrame: Day 1 to Day 28 of first 28-day dosing cycle
measure: Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515
timeFrame: Day 1 to Day 28 of first 28-day dosing cycle
measure: Efficacy analysis
timeFrame: Day 1 to end of Phase I study
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic
state: Tennessee
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: CMO/Study Physician
name: Margaret Dugan, MD
role: STUDY_DIRECTOR
References: