Actively Recruiting
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
Led by Apollo Therapeutics Ltd · Updated on 2026-01-07
100
Participants Needed
9
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- For Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic colorectal carcinoma, cholangiocarcinoma, or appendiceal adenocarcinoma
- For Phase 1 sub-studies: Diagnosed with colorectal carcinoma, cholangiocarcinoma, appendiceal adenocarcinoma, pancreatic adenocarcinoma, gastric adenocarcinoma, endometrial adenocarcinoma, triple negative breast cancer, ovarian cancer, or prostate cancer
- For Phase 2: Diagnosed with colorectal carcinoma
- No available standard therapy or ineligible for standard therapy; colorectal carcinoma patients must have previously received fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF therapy, and if wild-type RAS, anti-EGFR therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Body weight of at least 40 kg
- Female participants of childbearing potential must have negative pregnancy test at screening and agree to use contraception or avoid pregnancy during the study
- Male participants must agree to use contraception and not impregnate a partner during the study
- Willing and able to provide informed consent and comply with study requirements
You will not qualify if you...
- Active brain metastases or carcinomatous meningitis
- Unstable angina, recent myocardial infarction, significant ventricular arrhythmias, symptomatic congestive heart failure
- Uncontrolled active infection
- Significant hemorrhage within 4 weeks before first dose
- Intestinal disease or major gastric surgery
- Arterial thrombosis within 6 months of screening
- Anti-cancer treatment within 2 weeks before Cycle 1 Day 1
- Prior radiotherapy within 14 days before screening
- Active anti-coagulation therapy
- Use of over-the-counter, prescription, herbal medicines, or supplements within 14 days or 5 half-lives before cycle 1 day 1
- Major surgery within 1 month of screening
- Hemoglobin less than 9.0 g/dL
- Absolute neutrophil count less than 1.5 x 10^9/L
- Platelet count less than 100 x 10^9/L
- Liver function abnormalities: AST/ALT greater than 3 times upper limit of normal (5 times if liver metastases), total bilirubin greater than 1.5 times upper limit of normal except Gilbert's syndrome, albumin less than 3 g/dL
- Creatinine clearance less than 60 mL/min
- QTcF interval greater than 470 msec or family history of Long QT Syndrome
- Left ventricular ejection fraction less than 45% at rest
- Positive for HIV (unless controlled), hepatitis B or hepatitis C
AI-Screening
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Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Active, Not Recruiting
2
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Active, Not Recruiting
3
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States, 34232
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
Mary Crowley Cancer Research
Dallas, Texas, United States, 75251
Actively Recruiting
9
NEXT Oncology- San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
A
Apollo Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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