Investigating APL-5125 for advanced solid tumors

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

This study is testing a new drug called APL-5125 to see if it can help adults with advanced solid tumors, especially colorectal cancer, who have run out of other treatment options.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Apollo Therapeutics Ltd (industry)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Duarte, California and 8 other locations)
• Trial ID: NCT06399757 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1/2 study aims to evaluate the safety, tolerability, and efficacy of APL-5125 in adults with advanced solid tumors, particularly focusing on colorectal carcinoma. Participants will include those with histologically confirmed locally advanced, inoperable, or metastatic tumors. The study will assess the drug's effectiveness in patients who have exhausted standard treatment options. The trial will be conducted across multiple locations in California and Florida.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific advanced solid tumors who have not responded to standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies investigating similar therapies for advanced solid tumors have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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 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 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:

  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

Where this trial is running

Duarte, California and 8 other locations

• City of Hope — Duarte, California, United States (ACTIVE_NOT_RECRUITING)
• City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (ACTIVE_NOT_RECRUITING)
• Florida Cancer Specialists & Research Institute — Sarasota, Florida, United States (RECRUITING)
• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
• Duke Cancer Institute — Durham, North Carolina, United States (RECRUITING)
• Carolina BioOncology Institute — Huntersville, North Carolina, United States (RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
• Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
• NEXT Oncology- San Antonio — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Apollo Therapeutics

Conditions: Colorectal Cancer, Cholangiocarcinoma, Appendiceal Adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer