🏛️ Verified NIH Record • Updated 2026-08-12
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors (NCT06399757)
🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Apollo Therapeutics Ltd
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (15 items).
Location: City of Hope — Duarte, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart failure, uncontrolled active infection, history of significant hemorrhage within 4 weeks of the first dose date, intestinal disease or major gastric surgery, arterial thrombosis within 6 months of screening
- Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active anti-coagulation therapy, over the counter or prescription medications within 14 days or 5 half-lives prior to cycle 1 day 1, herbal medicines and supplements within 14 days
- Major surgery within 1 month of screening
- Hemoglobin \< 9.0 g/dL
- Absolute neutrophil count \< 1.5 x 10\^9/L
- Platelet count \< 100 x 10\^9/L
- Hepatic function:
- Aspartate aminotransferase and/or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) (\>5 x ULN for subjects with liver metastases)
- Total bilirubin \>1.5 × ULN (except participants with Gilbert's syndrome).
- Albumin \< 3 g/dL
- Calculated or measured creatinine clearance of \<60 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\] × Mass \[kg\] / \[72 × serum creatinine mg/dL\]). Multiply result by 0.85 if female.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (9 Sites)
- City of Hope — Duarte, California
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California
- Florida Cancer Specialists & Research Institute — Sarasota, Florida
- University of Michigan — Ann Arbor, Michigan
- Duke Cancer Institute — Durham, North Carolina
- Carolina BioOncology Institute — Huntersville, North Carolina
- Medical University of South Carolina — Charleston, South Carolina
- Mary Crowley Cancer Research — Dallas, Texas
- NEXT Oncology- San Antonio — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.