← Back to Search

PD-1 Inhibitor

RBN-2397 + Pembrolizumab for Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Melissa Johnson, MD

Research Sponsored by Ribon Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (an average of 6 months)

Awards & highlights

Study Summary

This trial will study RBN-2397, a new drug that inhibits an enzyme called PARP7, which is switched on by cancer stresses. Cancer cells use PARP7 to hide from the immune system, but RBN-2397 has been shown in animal and human studies to inhibit tumor growth and also shuts down the "don't kill me" signal the tumor is sending to evade the immune system. This trial will study whether RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) can restore the response to treatment in patients with SCCL who have been previously treated with a PD-

Eligible Conditions

Squamous Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (an average of 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (an average of 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (an average of 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine recommended Phase 2 dose (RP2D) (Phase 1b)

Overall Response Rate (Phase 2)

Secondary outcome measures

AUC of RBN-2397

Cmax of RBN-2397

Safety determined by Treatment-Emergent Adverse Events

+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: RBN-2397 in combination with pembrolizumabExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ribon Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

202 Total Patients Enrolled

Melissa Johnson, MDPrincipal InvestigatorTennessee Oncology

6 Previous Clinical Trials

832 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05127590 — Phase 1 & 2

Lung Cancer Research Study Groups: RBN-2397 in combination with pembrolizumab

Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05127590 — Phase 1 & 2

Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127590 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this investigation currently?

"Affirmative, according to clinicaltrials.gov this trial is still enrolling patients. It was created on March 15th 2022 and its most recent update occurred November 13th of the same year. This research requires 50 participants to be drawn from 4 distinct sites."

Answered by AI

What indications is RBN-2397 commonly employed to ameliorate?

"RBN-2397 is a common remedy for malignant neoplasms, but it can also have positive results when used to treat unresectable melanoma, microsatellite instability high cases or patients experiencing disease progression after chemotherapy."

Answered by AI

Are individuals aged 80 or higher being recruited for this trial?

"As per the requirements of this medical trial, potential participants must be aged 18-99."

Answered by AI

What is the current sample population size of this experiment?

"This trial requires fifty participants that satisfy a given set of eligibility requirements. Patients can join from various medical centres, such as Sarah Cannon Research Institute in Nashville or Cancer Treatment Centers of America in Newnan."

Answered by AI

In which sites can participants access this investigation?

"Currently, this trial is running at 4 locations throughout the nation: Nashville, Newnan and Newark being three of them. To decrease travelling demands for participants, it's recommended to choose a facility close-by if you decide to join."

Answered by AI

What is the intended outcome of this medical experiment?

"According to Ribon Therapeutics, Inc., the main target evaluated over 78 weeks of treatment is determining a recommended phase 2 dose (RP2D) for Phase 1b. Additionally, this study will be observing secondary objectives including the peak concentration (Cmax), time until maximum plasma concentration (Tmax), and terminal half-life (T1/2)."

Answered by AI

Am I eligible to volunteer for this medical experiment?

"This medical experiment is looking for 50 individuals between the ages of 18 and 99 with carcinoma. To be eligible, these people must have already undergone therapy involving a platinum doublet combined with an ICI such as anti-PD1/anti PD-L1 or CTLA4 inhibitors either separately or in combination chemo + checkpoint inhibitor, plus possess an ECOG performance status score of 0 to 1."

Answered by AI

Has RBN-2397 been studied in any other research investigations?

"RBN-2397 was initially explored a decade ago at the City of Hope. This compound has been subject to 249 completed studies and continues to be studied in 961 active clinical trials, with several sites based out of Nashville, Tennessee."

Answered by AI