A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Cyclin A/B-RxL Inhibitor CID-078 in Patients With Advanced Solid Tumor Malignancies
Circle Pharma
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.
Description
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 (Arginine-any amino acid-lysine) inhibitor, in patients with advanced solid tumors. The study will be conducted at approximately 20 centers. CID-078 will be evaluated as an oral therapeutic. This study is divided into three parts: Part 1a Dose Escalation, Part 1b New Formulation Dose Escalation/Pilot Food Effect and Part 2 Dose Expansion. Part 1a will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CID-078, and identify recommende…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Part 1a/1b Inclusion Criteria: A patient must meet all of the following inclusion criteria to be eligible to participate in this study. 1. Solid tumor malignancy meeting the following criteria: * 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 al…
Interventions
- DrugCID-078 Monotherapy
Cyclin A/B-RxL inhibitor, twice-a-day in repeating 21-day treatment cycles until disease progression or discontinuation criteria.
Locations (10)
- Florida Cancer SpecialistsSarasota, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- START MidwestGrand Rapids, Michigan
- Comprehensive Cancer Centers of NevadaLas Vegas, Nevada
- UH Seidman Cancer CenterCleveland, Ohio
- Oregon Health and Science UniversityPortland, Oregon