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APL-5125 for Advanced Solid Tumors

This study is testing a new oral drug called APL-5125 for adults with advanced solid tumors that are locally advanced (spread to nearby tissues), inoperable, or metastatic (spread to other parts of the body). This includes colorectal cancer, cholangiocarcinoma, appendiceal adenocarcinoma, pancreatic adenocarcinoma, and gastric adenocarcinoma. The main goals are to understand how safe APL-5125 is, how well people tolerate it, and how effective it is, especially for colorectal cancer. Researchers will also look at certain markers in your body, like EGFR, KRAS, and NRAS, and how the drug affects VEGF (a protein involved in blood vessel growth). The study is currently recruiting about 100 participants.

Study design
This is an open-label, Phase 1/2 study, meaning both you and your doctors will know which treatment you are receiving. It aims to enroll 100 participants.
What's involved
You would take APL-5125 as an oral capsule daily in 28-day cycles. The study will monitor your safety and tolerability through study completion, which is approximately one year.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored through study completion, which is approximately one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06399757

A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Apollo Therapeutics Ltd
~100 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:APL-5125

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment Emergent Adverse Events [Safety]
Measured over Through study completion, approximately one year
+3 more outcomes measured

Conditions

Colorectal Cancer
Cholangiocarcinoma
Appendiceal Adenocarcinoma
Pancreatic Adenocarcinoma
Gastric Adenocarcinoma
Endometrial Adenocarcinoma
Triple Negative Breast Cancer
Ovarian Cancer
Prostate Cancer

Explore related trials

Appendix AdenocarcinomaCholangiocarcinomaColorectal CarcinomaEndometrial AdenocarcinomaGastric AdenocarcinomaMalignant Ovarian NeoplasmPancreatic AdenocarcinomaProstate CarcinomaSolid NeoplasmTriple-negative breast cancer

Where it's being run

9 sites across 6 states
California2
North Carolina2
Texas2
Florida1
Michigan1
South Carolina1

Study leadership

  • Sanjay Aggarwal, MD · STUDY_CHAIR · Apollo Therapeutics Ltd

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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

Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart failure, uncontrolled active infection, history of significant hemorrhage within 4 weeks of the first dose date, intestinal disease or major gastric surgery, arterial thrombosis within 6 months of screening
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:
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

What this trial measures

  • Incidence of Treatment Emergent Adverse Events [Safety]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)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)Approximately one year
  • Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)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