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.
Part 1a Dose Escalation and Part 1b New Formulation Dose Escalation/Pilot Food Effect Cohort: locally advanced or metastatic solid tumor malignancy that has progressed or was non responsive to available therapies and for which no standard or available curative therapy exists.
Part 1a and Part 1b Backfill: patients with TNBC, SCLC, and solid tumors harboring a RB1 or CDKN2A/B loss genomic alteration or Rb protein LoF. Additional tumor types or genomic alterations may be considered by the SRC as data become available. Patient must have progressed or was non-responsive to available therapies and for which no standard or available curative therapy exists
Measurable disease per RECIST v1.1.
Age ≥ 18 years.
Targeted therapy ≤ eight days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to the first dose of study drug.
Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to first dose of study drug.
Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to the first dose of study drug. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.
Immunotherapy ≤ 28 days prior to the first dose of study drug.
Single group
CID-078 Monotherapy
DrugCyclin A/B-RxL inhibitor, twice-a-day in repeating 21-day treatment cycles until disease progression or discontinuation criteria.
Part 1: Incidence of Treatment Emergent Adverse Events (TEAEs) based on CTCAE v5.0.
Part 1: Incidence of Treatment Related Adverse Events (TRAEs) based on CTCAE v5.0.
Part 1: Incidence of Dose-Limiting Toxicities (DLTs).
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.
Part 1: Percentage of patients with confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors.
Part 1: Duration of confirmed objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors.
Part 1: Duration of disease progression free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria in Solid Tumors.
Part 1: Maximum plasma concentration (Cmax) of CID-078 in fasted and fed state.
Click on the lead sponsor to view all of their trials.
