RBN-2397 + Pembrolizumab for Small Cell Lung Cancer

Recruiting at21 trial locations

Overseen by Melissa Johnson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Ribon Therapeutics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, RBN-2397, along with pembrolizumab in patients with advanced lung cancer who have not responded to previous treatments. RBN-2397 helps stop cancer cells from hiding from the immune system, while pembrolizumab helps the immune system attack the cancer.

Research Team

Melissa Johnson, MD

Principal Investigator

Tennessee Oncology

Eligibility Criteria

Inclusion Criteria

The last regimen prior to enrolling in the study must be a checkpoint inhibitor-containing regimen where the best response for at least one tumor response assessment was stable disease (SD), partial response (PR), or complete response (CR).

Must agree to undergo tumor biopsy if medically safe and feasible. Archival biopsy samples may be submitted if fresh biopsy can't be obtained.

Confirmed diagnosis of advanced/metastatic NSCLC of squamous cell histology as determined by local testing practices.

Exclusion Criteria

Prior radiation within 2 weeks of Cycle 1 Day 1 (C1D1), except for palliative radiotherapy to a limited field. Patients must have recovered from all radiation related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non CNS disease

Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial

A patient with CNS metastases is excluded if: Has active CNS metastases (new lesions or progression from prior imaging study) requiring treatment within 28 days prior to study treatment and/or ongoing corticosteroid therapy

Treatment Details

Interventions

• Pembrolizumab (PD-1 Inhibitor)
• RBN-2397 (PARP7 Inhibitor)

Participant Groups

Group I: RBN-2397 in combination with pembrolizumab Experimental Treatment 1 Intervention

RBN-2397 orally in combination with the fixed approved dose of IV pembrolizumab

Who Is Running the Clinical Trial?

Ribon Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

250+