NCT06399757 · Apollo Therapeutics Ltd
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
What this study is about
This is an where both patients and doctors know the treatment given, Phase 1/2 study to determine the safety, tolerability, and effectiveness of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).
View original scientific description
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).
Interventions
DRUG
APL-5125
APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
Primary outcome measures
Incidence of Treatment Emergent Adverse Events [Safety]
Time frame: Through study completion, approximately one year
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results.
Incidence of dose limiting toxicities [Tolerability] (Phase 1)
Time frame: Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)
Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs and electrocardiogram results
Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1)
Time frame: Approximately one year
Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)
Time frame: Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)
Response is assessed per RECIST version 1.1 criteria
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years or older
- Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.
- For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer, Prostate Cancer
- Phase 2: Colorectal carcinoma
- No available standard of care therapy or participant is ineligible for standard of care therapy, except in CRC tumor type in which participant must have previously received all the following therapeutic agents:
- fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
- an anti-VEGF therapy
- if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Body Weight ≥40 kg.
- Female participants of childbearing potential must have negative serum pregnancy test at scre
Where
- Duarte, California
- Irvine, California
- Sarasota, Florida
- Ann Arbor, Michigan
- Durham, North Carolina
- Huntersville, North Carolina
- Charleston, South Carolina
- Dallas, Texas
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations