RBN-2397 in Combination With Pembrolizumab in Patients With SCCL
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ClinicalTrials.gov Identifier: NCT05127590 |
Recruitment Status :
Active, not recruiting
First Posted : November 19, 2021
Last Update Posted : July 3, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | November 4, 2021 | ||||
First Posted Date ICMJE | November 19, 2021 | ||||
Last Update Posted Date | July 3, 2023 | ||||
Actual Study Start Date ICMJE | March 15, 2022 | ||||
Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | RBN-2397 in Combination With Pembrolizumab in Patients With SCCL | ||||
Official Title ICMJE | A Phase 1b/2, Multicenter, Single Arm Study of RBN-2397 in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung (SCCL) | ||||
Brief Summary | RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. 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. The purpose of this study is to determine if RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) has the ability to restore the response to treatment in patients with SCCL that have been previously treated with a PD-1/PD-1 ligand (PD-L1) inhibitor and have had a response followed by disease progression. The Phase 1b portion of the study will assess the safety of RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) and define the dose of RBN-2397 to be used in combination with pembrolizumab for the Phase 2. The Phase 2 portion of the study will assess the anti-tumor activity of RBN-2397 in combination with pembrolizumab. |
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Detailed Description | This is an open label, multicenter Phase 1b/2 single arm study that will evaluate the safety and antitumor activity of RBN-2397 in combination with pembrolizumab in patients with confirmed diagnosis of advanced squamous cell carcinoma of the lung who have received prior therapy. The study consists of a Phase 1b Safety Run in and Phase 2. During the Phase 1b Safety Run-in, approximately 10 patients will be enrolled in a 3+3 fashion and treated with continuous oral dosing with RBN-2397 twice daily (BID) in combination with the fixed approved dose of intravenous (IV) pembrolizumab every 3 weeks [Q3W]) to establish RP2D of RBN-2397 in combination with pembrolizumab. During Phase 2, approximately 40 patients will be treated with continuous oral dosing with the RP2D of RBN-2397 BID in combination with the fixed approved dose of IV pembrolizumab. In both the Phase 1b Safety Run in and Phase 2, a treatment cycle is defined as 21 days. On Day 1 of each treatment cycle, RBN-2397 will be administered orally and followed by IV infusion of pembrolizumab at the fixed approved dose according to the approved local product label. During the remaining days of the 21-day treatment cycle, only RBN-2397 BID will be administered. Treatment cycles will continue until disease progression, unacceptable treatment-related toxicity, or withdrawal of consent |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: RBN-2397 in combination with pembrolizumab Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Advanced Squamous Non-Small Cell Lung Carcinoma | ||||
Intervention ICMJE | Drug: RBN-2397
Continuous oral dosing with the RP2D of RBN-2397 (outpatient basis). Pembrolizumab IV infusion over 30 minutes in clinic on Day 1 of each cycle.
Other Names:
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Study Arms ICMJE | Experimental: RBN-2397 in combination with pembrolizumab
RBN-2397 orally in combination with the fixed approved dose of IV pembrolizumab
Intervention: Drug: RBN-2397
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2023 | ||||
Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Israel, Spain, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05127590 | ||||
Other Study ID Numbers ICMJE | RBN-2397-21-002 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Ribon Therapeutics, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Ribon Therapeutics, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Ribon Therapeutics, Inc. | ||||
Verification Date | June 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |