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RBN-2397 for Squamous Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Squamous Cell Lung CancerRBN-2397 - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Relacorilant
1
SRF388
1
RM-1995

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: through study completion (an average of 6 months)

Week 78
Overall Response Rate (Phase 2)
Day 90
Safety determined by Treatment-Emergent Adverse Events
Through Study Day 22
AUC of RBN-2397
Cmax of RBN-2397
T1/2 of RBN-2397
Tmax of RBN-2397
Month 6
Determine recommended Phase 2 dose (RP2D) (Phase 1b)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Relacorilant
1
SRF388
1
RM-1995

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

RBN-2397 in combination with pembrolizumab
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: RBN-2397 · No Placebo Group · Phase 1 & 2

RBN-2397 in combination with pembrolizumab
Drug
Experimental Group · 1 Intervention: RBN-2397 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion (an average of 6 months)

Who is running the clinical trial?

Ribon Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
202 Total Patients Enrolled
Melissa Johnson, MDPrincipal InvestigatorTennessee Oncology
5 Previous Clinical Trials
709 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient and their companion must be committed to use effective contraception during the duration of, as well as three months after, taking part in the study medication.
You have been diagnosed with an advanced or metastatic squamous non-small cell lung cancer based on local testing.
Patients must have had prior treatment with a platinum-based chemotherapy and an immunotherapy such as anti-PD-1/anti-PD-L1, or CTLA4 inhibitors either individually or in combination with chemo.
The preceding treatment program must have included a checkpoint inhibitor, and yielded at least one documented outcome of SD, PR or CR.
Patients exhibited symptoms of PD as judged by the investigator during or after their most recent treatment program.
You must consent to a tumor biopsy if it is both safe and practical
Your ECOG performance status is between 0 and 1.
You have had a computed tomography or magnetic resonance imaging scan within the past month and you possess at least one discernible lesion.
Your organs and bone marrow are functioning normally.
References

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