A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
NCT ID: NCT06399757
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2024-06-18
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
NCT04645797
Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer
NCT01167725
Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer
NCT06197425
Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
NCT00008281
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
NCT00069108
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1: Dose Escalation
Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose.
Possibility to expand into select populations
APL-5125
APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
Phase 2: Dose Expansion/Optimization
At least 2 dose levels of APL-5125 in a selected population
APL-5125
APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
APL-5125
APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse
* Male participants must be willing to use specific contraception and not plan to impregnate a female partner or donate sperm while on study
* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial
Exclusion Criteria
* 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:
1. Aspartate aminotransferase and/or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) (\>5 x ULN for subjects with liver metastases)
2. Total bilirubin \>1.5 × ULN (except participants with Gilbert's syndrome).
3. 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.
* Fridericia's corrected QT interval (QTcF) \>470 msec or a family history of Long QT Syndrome.
* Cardiac function: Echocardiogram (or MUGA) showing Left Ventricular Ejection Fraction (LVEF) \<45% at rest
* Infectious diseases: positive for HIV (unless controlled with active retroviral therapy), hepatitis B and hepatitis C
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Apollo Therapeutics Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sanjay Aggarwal, MD
Role: STUDY_CHAIR
Apollo Therapeutics Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Duke Cancer Institute
Durham, North Carolina, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
NEXT Oncology- San Antonio
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AP10CP01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.