RecruitingPhase 1Phase 2NCT06526819

SMP-3124LP in Adults With Advanced Solid Tumors

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors


Sponsor

Sumitomo Pharma America, Inc.

Enrollment

120 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SMP-3124LP in patients with various advanced solid tumors. SMP-3124LP works by blocking certain proteins (checkpoint kinases) that cancer cells rely on to survive DNA damage from treatment, potentially making tumors more vulnerable. The study is looking at safety, dosing, and early signs of effectiveness. **You may be eligible if...** - You have an advanced, recurrent, or metastatic solid tumor that has progressed on standard therapy, including one of the following: platinum-resistant ovarian cancer, triple-negative breast cancer, anal squamous cell carcinoma, head and neck squamous cell carcinoma, non-small cell lung cancer, or uterine serous cancer - You are in good enough health to participate (ECOG performance status of 2 or below) - Your blood counts, liver, and kidney function meet required thresholds - You agree to use effective contraception during and for 6 months after treatment **You may NOT be eligible if...** - You have previously received a cell cycle checkpoint inhibitor drug - You have brain or leptomeningeal metastases - You have significant heart problems (including ejection fraction below 45%) - You are currently on strong medications that interact with this drug (certain CYP inhibitors) - You are pregnant or breastfeeding - You have had recent cancer treatment or major surgery within 14 and 28 days, respectively Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSMP3124LP

Liposomal encapsulation formulation of SMP-3124


Locations(10)

Cedars Sinai Medical Center

Los Angeles, California, United States

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States

Northwestern Medicine Cancer Center

Chicago, Illinois, United States

Ohio State University

Columbus, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

National Cancer Center Hospital East

Kashiwa-shi, Japan

Kyoto University Hospital

Kyoto, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06526819


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