Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies

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 recommended dose for expansion (RDE) of CID-078 using a Backfill Bayesian Optimal Interval design. Dose escalation will occur sequentially over several dose levels.

Part 1b will evaluate the safety and tolerability of a new CID-078 oral formulation, investigate the pharmacokinetic exposure between the original and new CID-078 formulations, and evaluate the effect of food on CID-078 pharmacokinetics. Part 1b will be initiated upon availability of the new CID-078 oral formulation.

Part 2 is a Dose Expansion. Upon identification of the RDE as determined by the SRC, CID-078 will be further evaluated for it's antitumor activity/efficacy along with characterization of it's safety, tolerability, pharmacokinetics, and pharmacodynamics in three tumor specific cohorts: TNBC, SCLC, and solid tumors harboring a RB1 alteration or Rb protein LoF; with an additional possible cohort expansion of N=20 for either TNBC or RB1-altered solid tumor cohort based on data observed.

The study consists of a 28-day Screening Period, a Treatment Period, an End of Treatment (EOT) Visit, and a Safety Follow-up Visit. After confirming eligibility, patients enter the Treatment Period that consists of repeating 21-day treatment cycles. Study drug treatment cycles will continue for as long as the patient does not meet study drug discontinuation criteria. Within 7 days of the last dose of study drug or the decision to withdraw from the study, patients will undergo an EOT visit and a Safety Follow-Up visit 28 days after the EOT visit.