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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
City of Hope
Duarte, California, United States
ACTIVE_NOT_RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
ACTIVE_NOT_RECRUITINGFlorida Cancer Specialists & Research Institute
Sarasota, Florida, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGDuke Cancer Institute
Durham, North Carolina, United States
RECRUITINGCarolina BioOncology Institute
Huntersville, North Carolina, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
RECRUITINGNEXT Oncology- San Antonio
San Antonio, Texas, United States
RECRUITINGIncidence 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.
Time frame: Through study completion, approximately one year
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
Time frame: 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)
Time frame: Approximately one year
Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)
Response is assessed per RECIST version 1.1 criteria
Time frame: Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)
Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)
Response is assessed per RECIST version 1.1 criteria
Time frame: Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)
Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)
Evaluate PK parameters: oral clearance
Time frame: On days 1, 2, 4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).
Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)
Evaluate PK parameters: volume of distribution
Time frame: On days 1, 2 ,4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).
Evaluate biomarker(s) in the tumor
Assessment of biomarker(s) in pre- and post-treatment tumor tissue
Time frame: Through study completion, approximately one year
Further assess the anti-tumor activity of APL-5125 (Phase 2)
Response is assessed per RECIST version 1.1 criteria
Time frame: Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)
Incidence of treatment emergent adverse events [Further Safety] (Phase 2)
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results
Time frame: Through study completion (approximately 2 years)
Further assess the PK of APL-5125 (Phase 2)
Evaluate PK parameters: oral clearance
Time frame: On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).
Further assess the PK of APL-5125 (Phase 2)
Evaluate PK parameters: volume of distribution
Time frame: On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.