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).
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
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
Sequential
APL-5125
DrugAPL-5125 is an oral drug (capsule) taken daily in 28-day cycles
Incidence of Treatment Emergent Adverse Events [Safety]
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)
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)
Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)
Response is assessed per RECIST version 1.1 criteria
Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)
Response is assessed per RECIST version 1.1 criteria
Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)
Evaluate PK parameters: oral clearance
Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)
Evaluate PK parameters: volume of distribution
Evaluate biomarker(s) in the tumor
Assessment of biomarker(s) in pre- and post-treatment tumor tissue
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