Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
NCT Number: NCT06577987
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor|Metastatic Solid Tumor|Refractory Solid Tumor|Cancer|Lung Cancer|Triple Negative Breast Cancer|Breast Neoplasms|Neuroendocrine Tumors|Neuroendocrine Carcinoma
Interventions: DRUG: CID-078 Monotherapy
Sponsor: Circle Pharma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-14
Completion Date: 2027-03-14
Locations: START Midwest, Grand Rapids, Michigan, 49546, United States|NEXT Oncology, San Antonio, Texas, 78229, United States|START Mountain, West Valley City, Utah, 84119, United States

Summary:
This is a first-in-human, multicenter, open-label, phase 1 study to evaluate safety, tolerability, and efficacy of CID-078, a Cyclin A/B-RxL inhibitor, in patients with advanced solid tumors.

Primary Outcome Measures: Part 1: Incidence of Treatment Emergent Adverse Events (TEAEs) based on CTCAE v5.0., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1: Incidence of Treatment Related Adverse Events (TRAEs) based on CTCAE v5.0., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1: Incidence of Dose-Limiting Toxicities (DLTs)., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to end of cycle 1, up to 21 + 4 days.|Part 1: To determine recommended dose(s) for expansion (RDEs) for evaluation for Part 2., The RDEs will be determined using all available information, including, but not limited to, AEs, dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures observed in Part 1 Dose Escalation., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 2: Percentage of patients with confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 2: Duration of confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 2: Duration of disease progression free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 2: To determine Provisional Recommended Phase 2 Dose (RP2D) for future dose optimization., The RP2D will be determined using all available information, including, but not limited to, Adverse Events (AEs), dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures observed during the study., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.
Secondary Outcome Measures: Part 1: Percentage of patients with confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1: Duration of confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1: Duration of disease progression free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1 and Part 2: Maximum plasma concentration (Cmax) of CID-078 in fasted and fed state., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1 and Part 2: Time to maximum plasma concentration (Tmax) of CID-078 in fasted and fed state., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1 and Part 2: Area under the concentration-time curve (AUC) of CID-078 in fasted and fed state., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 1 and Part 2: Terminal half-life (t1/2) of CID-078 in fasted and fed state., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 2: Incidence of Treatment Emergent Adverse Events (TEAEs) based on CTCAE v5.0., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.|Part 2: Incidence of Treatment Related Adverse Events (TRAEs) based on CTCAE v5.0., From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug.