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

NCT06399757 · Apollo Therapeutics Ltd
In plain English

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Official title
A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors
About this study
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).
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
Study design
Enrollment target: 100 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06-18
Estimated completion: 2027-05
Last updated: 2026-01-07
Interventions
Drug: APL-5125
Primary outcomes
  • Incidence of Treatment Emergent Adverse Events [Safety] (Through study completion, approximately one year)
  • Incidence of dose limiting toxicities [Tolerability] (Phase 1) (Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days))
  • Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1) (Approximately one year)
Sponsor
Apollo Therapeutics Ltd · industry
Contacts & investigators
ContactApollo Therapeutics · contact · AP10@apollotx.com · 781-479-2267
InvestigatorSanjay Aggarwal, MD · study_chair, Apollo Therapeutics Ltd
All locations (9)
City of HopeActive Not Recruiting
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer CenterActive Not Recruiting
Irvine, California, United States
Florida Cancer Specialists & Research InstituteRecruiting
Sarasota, Florida, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
Carolina BioOncology InstituteRecruiting
Huntersville, North Carolina, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
NEXT Oncology- San AntonioRecruiting
San Antonio, Texas, United States
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors · TrialPath