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Recruiting NCT06463340

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

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SGR-3515.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence and severity of adverse events (AEs) [Time frame: Day 1 to 28 days after the last dose of SGR-3515.]
  • Incidence of Dose Limiting Toxicities (DLTs) [Time frame: Day 1 to Day 28 of the first 28-day dosing cycle.]
  • Incidence of serious adverse events (SAEs) [Time frame: Day 1 to 28 days after the last dose of SGR-3515]
  • Recommended phase 2 dose and schedule [Time frame: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.]
Secondary outcome measures (5)
  • Pharmacokinetics: Measures Cmax and Cmin of SGR-3515 [Time frame: Day 1 to Day 28 of first 28-day dosing cycle]
  • Pharmacokinetics Measures: t1/2 of SGR-3515 [Time frame: Day 1 to Day 28 of first 28-day dosing cycle]
  • Pharmacokinetics Measures: tmax of SGR-3515 [Time frame: Day 1 to Day 28 of first 28-day dosing cycle]
  • Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515 [Time frame: Day 1 to Day 28 of first 28-day dosing cycle]
  • Efficacy analysis [Time frame: Day 1 to end of Phase I study]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • Yale University, Yale Cancer Center — New Haven
  • Northwestern University — Chicago
  • University of Michigan — Ann Arbor
  • Karmanos Cancer Institute — Detroit
  • Icahn School of Medicine at Mount Sinai — New York
  • Levine Cancer Institute — Charlotte
  • University of Cincinnati Medical Center — Cincinnati
  • Ohio State University — Columbus
  • … and 5 more centers
Canada · 1 center
  • Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT06463340 · SGR-3515-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗