Actively Recruiting
A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors
Led by Apollo Therapeutics Ltd · Updated on 2026-01-07
100
Participants Needed
9
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating APL-5125, an investigational oral drug, for its safety, tolerability, and anti-tumor activity in adults with selected advanced solid tumors, focusing especially on colorectal cancer. This open-label study includes both Phase 1 and Phase 2 stages to explore APL-5125's effects in patients with various cancers that have advanced locally or spread to other parts of the body. The study involves a Phase 1 dose escalation to find the recommended dose for Phase 2 by administering increasing oral doses of APL-5125 daily in 28-day cycles. Following dose identification, Phase 2 expands to assess the drug's activity in colorectal cancer patients. Participants receive at least two dose levels, with tumor response assessments every 8 weeks initially and every 12 weeks after one year, continuing for up to two years. Participants will be monitored for treatment-emergent side effects, dose-limiting toxicities, and drug pharmacokinetics through scheduled visits and laboratory tests across the study. Safety and tumor biomarkers will be evaluated throughout approximately one to two years. The study requires regular assessments including tumor response scans and blood tests to ensure participant safety and to measure the drug's effects over time.
CONDITIONS
Brief 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
- Histologically confirmed locally advanced, inoperable, or metastatic colorectal carcinoma, cholangiocarcinoma, or appendiceal adenocarcinoma (Phase 1)
- For Phase 1 sub-studies: colorectal carcinoma, cholangiocarcinoma, appendiceal adenocarcinoma, pancreatic adenocarcinoma, gastric adenocarcinoma, endometrial adenocarcinoma, triple negative breast cancer, ovarian cancer, or prostate cancer
- Colorectal carcinoma for Phase 2
- No available standard of care therapy or ineligible for standard care; colorectal cancer patients must have received fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF therapy, and if wild-type RAS, an anti-EGFR therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Body weight of 40 kg or more
- Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception or avoid intercourse during the study
- Male participants must agree to use contraception and not impregnate partners 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, or 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 of study start
- Prior radiotherapy within 14 days before screening
- Active anti-coagulation therapy or recent use of certain medications or supplements within 14 days prior to study
- Major surgery within 1 month of screening
- Low hemoglobin (<9.0 g/dL), low neutrophil count (<1.5 x 10^9/L), or low platelet count (<100 x 10^9/L)
- Liver function abnormalities: elevated AST/ALT (>3x ULN or >5x ULN with liver metastases), high total bilirubin (>1.5x ULN except Gilbert's syndrome), or low albumin (<3 g/dL)
- Reduced kidney function (creatinine clearance <60 mL/min)
- Prolonged QTc interval (>470 msec) or family history of Long QT Syndrome
- Reduced cardiac function (LVEF <45% at rest)
- Positive for HIV (unless controlled), hepatitis B, or hepatitis C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive the oral drug APL-5125 daily in 28-day cycles to assess safety and anti-tumor activity.
Visits every 8 weeks during the first year, then every 12 weeks afterwards
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
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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