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PARP7 Inhibitor

RBN-2397 for Solid Tumors

Phase 1
Recruiting
Led By Melissa L 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
Dose Escalation Phase only: Metastatic or advanced-stage solid malignant tumor (which may include "solid" lymphoma [e.g., mantle cell]) for whom no therapy exists that would be curative or might provide clinical benefit.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (an average of one year)
Awards & highlights

Study Summary

This trial is testing a new drug, RBN-2397, which inhibits an enzyme called PARP7. This enzyme is switched on by cancer stresses, and allows cancer cells to hide from the immune system. RBN-2397 has been shown in animal studies to inhibit tumor growth and also shuts down the "don't kill me" signal the tumor is sending to evade the immune system. The primary purpose of this study is to determine the maximum tolerated dose of orally administered RBN-2397 in patients with advanced or metastatic solid tumors.

Eligible Conditions
  • Solid Tumors, Adult

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a type of cancer that has spread and is in an advanced stage, and there is no curative or beneficial treatment available.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6-8 weeks; through study completion (an average of one year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6-8 weeks; through study completion (an average of one year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Antitumor activity that may be associated with RBN-2397 treatment
Antitumor activity that may be associated with RBN-2397 treatment assessed by CT/MRI Response Evaluation Criteria for Solid Tumors (RECIST) Criteria v1.1
Area under the plasma concentration for tablet manufactured with micronized RBN-2397 relative to unmicronized RBN-2397 (standard tablet) (Relative Bioavailability Cohorts only)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RBN-2397Experimental Treatment1 Intervention
Dose Escalation: Multiple doses of RBN-2397 for oral administration Dose Expansion: Oral dose of RBN-2397 as determined during Dose Escalation

Find a Location

Who is running the clinical trial?

Ribon Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
122 Total Patients Enrolled
Melissa L Johnson, MDPrincipal InvestigatorTennessee Oncology, PLLC

Frequently Asked Questions

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

What is the scale of enrollment for this medical research project?

"To conduct this study, Ribon Therapeutics, Inc. must enlist 130 eligible participants to be split between Washington University in St Louis and SCRI-Denver/HealthOne in Denver."

Answered by AI

Is this experiment still recruiting participants?

"Clinicaltrials.gov affirms that this trial began on August 1st 2019, and is currently seeking eligible candidates. Most recently the study was updated on July 5th 2022."

Answered by AI

Has RBN-2397 attained regulatory authorization from the Food and Drug Administration?

"Our team at Power assigned a score of 1 to RBN-2397's safety, as this is an early phase clinical trial with limited evidence regarding efficacy and hazard."

Answered by AI

How numerous are the venues currently conducting this experiment?

"Clinical trial sites operating for this medical study include Washington University in Saint Louis, SCRI-Denver/HealthOne in Denver, and SCRI-Nashville/Tennessee Oncology in Nashville. In addition to these centres, there are 8 other hubs that have been approved by the research team."

Answered by AI
~23 spots leftby Mar 2025