CID-078 for Cancer

Recruiting at 9 trial locations

Overseen By Lisa Kopp, DO, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Circle Pharma

Must not be taking: QT prolonging drugs

Disqualifiers: Brain metastases, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Variable (21-day cycles)

220 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had certain cancer treatments or surgeries within specific time frames before starting the trial.

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with advanced solid tumors, including various cancers like breast and lung cancer. Participants should have a tumor that's progressed after treatment or has no satisfactory alternative treatment.

Inclusion Criteria

Life expectancy greater than 12 weeks

My breast cancer can be measured by specific medical criteria.

I can swallow pills.

Exclusion Criteria

I have side effects from cancer treatment that are not hair loss or skin color changes.

QTc interval (using Fridericia correction calculation) > 470 msec

I have a history of interstitial lung disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive CID-078 in 21-day treatment cycles during Dose Escalation and Dose Expansion phases

Variable (21-day cycles)

End of Treatment

End of Treatment visit conducted within 7 days of the last dose or decision to withdraw

Safety Follow-up

Participants are monitored for safety 28 days after the End of Treatment visit

4 weeks

Treatment Details

Interventions

• CID-078

Trial Overview The study is testing CID-078 Monotherapy, which targets proteins involved in cell division. It's an early-phase trial to see how safe it is and how well it works at different doses in people with advanced cancer.

Participant Groups

Group I: Part 1a Dose Escalation, Part 1b New Formulation/Pilot Food Effect and Part 2 Dose Expansion Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Circle Pharma

Lead Sponsor

Trials

1

Recruited

100+