CBX-12 for Cancer

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Cybrexa Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called CBX-12 on patients with advanced tumors that haven't responded to other treatments. The goal is to find the safest and most effective dose by trying different schedules.

Research Team

Chief Medical Officer

Principal Investigator

Cybrexa Therapeutics

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors that have worsened after treatment, or when no approved therapy exists. Participants must have measurable disease and provide tumor samples. They can't join if they've had certain treatments within 3 weeks (2 weeks for some cases) before starting the study, are on other cancer treatments, have significant diseases, or active brain metastases without approval.

Inclusion Criteria

I agree to a biopsy of the same lesion as before, if it's safe.

My advanced cancer has worsened after treatment, or no approved treatment exists for it.

I have a recent tumor sample from a needle biopsy.

Exclusion Criteria

I haven't taken any small-molecule kinase inhibitors or hormonal agents in the last 14 days.

I have brain metastases but they are stable, or I have approval to join.

I have a serious health condition besides cancer.

Treatment Details

Interventions

• CBX-12 (Other)

Trial Overview CBX-12 is being tested in this Phase 1/2 trial to evaluate its safety and how it affects the body (pharmacokinetics). It's an open-label study where everyone gets CBX-12; there's a dose-escalation phase to find the right amount of drug that's safe and potentially effective.

Participant Groups

Group I: Phase 2 Ovarian Cancer Expansion Cohort Experimental Treatment 1 Intervention

CBX-12 administered TBD

Group II: Phase 2 Metastatic Breast Expansion Cohort Experimental Treatment 1 Intervention

CBX-12 administered TBD

Group III: Phase 1 Schedule C Dose Escalation (Once Weekly Dosing ) Experimental Treatment 1 Intervention

CBX-12 administered once weekly, 4 week schedule

Group IV: Phase 1 Schedule B Dose Escalation (Daily Dosing x 3) Experimental Treatment 1 Intervention

CBX-12 administered on a daily x 3, 3 week schedule

Group V: Phase 1 Schedule A Dose Escalation (Daily Dosing x 5) Experimental Treatment 1 Intervention

CBX-12 administered on a daily x 5, 3 week schedule

Group VI: Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks) Experimental Treatment 1 Intervention

CBX-12 administered once every 3 weeks

Who Is Running the Clinical Trial?

Cybrexa Therapeutics

Lead Sponsor

Trials

2

Recruited

190+