CUSP06 for Ovarian Cancer

Recruiting at 8 trial locations

Overseen By Priya Marreddy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: OnCusp Therapeutics, Inc.

Must not be taking: Antiseizure, Corticosteroids

Disqualifiers: Brain metastases, Lung disease, Cardiac disease, others

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

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that systemic antineoplastic therapy should not be taken within 5 half-lives or 4 weeks before the first dose of the study drug, whichever is shorter.

Eligibility Criteria

This trial is for adults over 18 with advanced solid tumors, including ovarian cancer that's not responding to platinum-based treatments. Participants need a certain level of health (ECOG status 0 or 1), enough white blood cells, platelets, and hemoglobin without recent transfusions. They must provide tumor tissue samples and consent to biopsies if needed.

Inclusion Criteria

Willingness to undergo a pretreatment biopsy if medically feasible and safe

Written informed consent provided prior to any screening procedures

Willingness to provide archival tumor tissue collected within the previous 2 years, when available

Exclusion Criteria

I have a lung condition that needed steroid treatment in the last 6 months.

Concurrent participation in another investigational clinical trial

Pregnant or breast-feeding females

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Finding - Phase 1a

Participants receive CUSP06 to evaluate safety, tolerability, and pharmacokinetics

36 months

Expansion as Monotherapy - Phase 1b

Further evaluation of CUSP06 efficacy and safety in a larger cohort

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• CUSP06

Trial Overview CUSP06 is being tested in this phase 1 study for safety and effectiveness in treating resistant ovarian cancer and other solid tumors. The trial will assess how the body processes the drug (pharmacokinetics) as well as its impact on the disease.

Participant Groups

Group I: Monotherapy Dose Finding - Phase 1a Experimental Treatment 1 Intervention

Group II: Expansion as Monotherapy - Phase 1b Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

OnCusp Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

180+