KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

Recruiting at 32 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kartos Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral medication called KRT-232 for patients with small cell lung cancer that has returned or resisted other treatments. The medication works by blocking a protein that helps cancer cells grow. The study will test different doses to find the most effective one. Niclosamide, originally a drug for treating parasitic infections, has shown potential in fighting small cell lung cancer.

Eligibility Criteria

Inclusion Criteria

ECOG ≤ 2

Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.

Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT

Exclusion Criteria

You have not received any chemotherapy, immune therapy, cytokine therapy, or experimental treatments in the two weeks leading up to the start of the study.

You have already received treatment with MDM2 inhibitors in the past.

You have had a major organ transplant in the past.

Treatment Details

Interventions

• KRT-232 (MDM2 Inhibitor)

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Group II: Arm 1 Experimental Treatment 1 Intervention

KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Who Is Running the Clinical Trial?

Kartos Therapeutics, Inc.

Lead Sponsor

Trials

17

Recruited

2,100+