RecruitingPhase 1Phase 2NCT06399757

A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors


Sponsor

Apollo Therapeutics Ltd

Enrollment

100 participants

Start Date

Jun 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called APL-5125 in people with advanced solid tumor cancers that no longer respond to standard treatments. The early phase focuses on colorectal, bile duct, and appendix cancers, with later phases including more tumor types. **You may be eligible if...** - You are 18 or older and weigh at least 40 kg - You have an advanced solid tumor cancer (such as colorectal, bile duct, appendix, pancreatic, endometrial, triple-negative breast, ovarian, or prostate cancer) - Standard treatments are no longer available or working for you - You have adequate heart, liver, kidney, and blood function **You may NOT be eligible if...** - You have active brain metastases (cancer spread to the brain) - You have had a heart attack, unstable angina, or significant bleeding in the last 4–6 weeks - You have had major surgery in the last month - You are HIV positive (unless well-controlled), or have active hepatitis B or C - Your blood counts or organ function are below required levels - You are pregnant or breastfeeding 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

DRUGAPL-5125

APL-5125 is an oral drug (capsule) taken daily in 28-day cycles


Locations(9)

City of Hope

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Florida Cancer Specialists & Research Institute

Sarasota, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Duke Cancer Institute

Durham, North Carolina, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

NEXT Oncology- San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06399757


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