National Trial Reference Number: NCT06577987

Sources for the below information are public registry websites such as ClinicalTrials.gov. It has been summarized and edited into simpler language. For full trial information about this clinical trial please visit https://clinicaltrials.gov. 

Purpose of the Study

The purpose of this study is to find the highest, safest dose of CID-078 that can be given to patients with advanced solid tumor malignancies and to evaluate the clinical activity of CID-078 in patients with selected solid tumor malignancies. 

About CID-078

CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that is designed to selectively target tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple xenograft models.

Key Inclusion/Exclusion Criteria

Inclusion Criteria:

• At least 18 years-old, Eastern Cooperative Oncology Group (ECOG) Score of 0-1.
• Locally advanced or metastatic solid tumor malignancy that has progressed or was nonresponsive to available therapies and for which no standard or available curative therapy exists.
• Have measurable disease (breast, lung cancer) or evaluable disease (all other solid tumors) per RECIST v1.1.
• Ability to swallow capsules by mouth.

Exclusion Criteria:

• Unresolved Grade ≥ 2 toxicities from previous treatment, except chronic/stable Grade 2 toxicities.
• Known or suspected brain metastases or spinal chord compression, unless condition has been treated, stable and asymptomatic. 
• QTc > 470 msec or require treatment medications known to prolong QT/QTc interval.
• Uncontrolled intercurrent illnesses including, but not limited to, uncompensated respiratory, cardiac, hepatic or renal disease, active infection, symptomatic congestive heart failure, unstable agina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.