OncoMatch/Clinical Trials/NCT06399757
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
Is NCT06399757 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies APL-5125 for colorectal cancer.
Treatment: APL-5125 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Cholangiocarcinoma
Pancreatic Cancer
Gastric Cancer
Endometrial Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Ovarian Cancer
Prostate Cancer
Biomarker criteria
Required: KRAS wild-type
Required: NRAS wild-type
Disease stage
Metastatic disease required
Histologically confirmed locally advanced, inoperable, or metastatic tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine-based chemotherapy
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Must have received: oxaliplatin-based chemotherapy
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Must have received: irinotecan-based chemotherapy
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Must have received: anti-VEGF therapy
an anti-VEGF therapy
Must have received: anti-EGFR therapy
if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy
Cannot have received: anti-cancer treatment
Exception: within 2 weeks of Cycle 1 Day 1
anti-cancer treatment within 2 weeks of Cycle 1 Day 1
Cannot have received: radiotherapy
Exception: within 14 days before screening
prior radiotherapy within 14 days before screening
Lab requirements
Blood counts
Hemoglobin < 9.0 g/dL; Absolute neutrophil count < 1.5 x 10^9/L; Platelet count < 100 x 10^9/L
Kidney function
Creatinine clearance of <60 mL/minute (Cockcroft and Gault)
Liver function
AST and/or ALT >3 × ULN (>5 x ULN for subjects with liver metastases); Total bilirubin >1.5 × ULN (except participants with Gilbert's syndrome); Albumin < 3 g/dL
Cardiac function
QTcF >470 msec or family history of Long QT Syndrome; LVEF <45% at rest
Hemoglobin < 9.0 g/dL; Absolute neutrophil count < 1.5 x 10^9/L; Platelet count < 100 x 10^9/L; AST/ALT >3 × ULN (>5 x ULN for subjects with liver metastases); Total bilirubin >1.5 × ULN (except participants with Gilbert's syndrome); Albumin < 3 g/dL; Creatinine clearance of <60 mL/minute; QTcF >470 msec or a family history of Long QT Syndrome; LVEF <45% at rest
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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