Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04053673
Status:
UNKNOWN
Last Update Posted:
2023-03-28
First Post:
2019-08-05
Brief Title:
Phase 1 Study of RBN-2397 an Oral PARP7 Inhibitor in Patients With Solid Tumors
Sponsor:
Ribon Therapeutics Inc
Organization:
Ribon Therapeutics Inc
Study Overview
Official Title:
A Phase 1 First-in-human Study of the Safety Single- and Multiple-Dose Pharmacokinetics and Preliminary Activity of Escalating Doses of RBN-2397 an Oral PARP7 Inhibitor in Patients With Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studies to inhibit tumor growth and also shuts down the dont kill me signal the tumor is sending to evade the immune system As a PARP7 inhibitor RBN-2397 is different from drugs inhibiting PARP1 PARP2 and PARP3 enzymes which are approved for the treatment of certain ovarian and breast cancers
The primary purpose of this study is to determine the maximum tolerated dose MTD of orally administered RBN-2397 in patients with advanced or metastatic solid tumors This study will also evaluate the safety and tolerability of RBN-2397 examine the pharmacokinetics PK measure how the body absorbs breaks down and eliminates RBN-2397 and investigate whether it has antitumor activity in solid tumor cancers
The primary purpose of this study is to determine the maximum tolerated dose MTD of orally administered RBN-2397 in patients with advanced or metastatic solid tumors This study will also evaluate the safety and tolerability of RBN-2397 examine the pharmacokinetics PK measure how the body absorbs breaks down and eliminates RBN-2397 and investigate whether it has antitumor activity in solid tumor cancers
Detailed Description:
This is a first-in-human Phase 1 multi-center open-label dose-escalation study to
Evaluate the safety profile and MTD of RBN-2397 administered orally and establish the RBN-2397 doses and schedules recommended for further investigation in Phase 2
Characterize the PK profile of RBN-2397
Identify preliminary antitumor activity
Biomarkers and their correlation with response to RBN-2397 and other outcomes will be examined
Cohorts will follow a traditional 3 3 design After enrollment of the first participant within a cohort there must be a wait period of at least 1 week before enrollment of additional participants in that cohort This dose escalation phase of the study is complete
The study is currently in the Relative Bioavailability and Expansion Cohorts phase where approximately 20 participants each will be enrolled to further examine the safety PK pharmacodynamics and antitumor activity of RBN-2397 at the recommended phase 2 dose
Relative Bioavailability Assessment
An evaluation of relative bioavailability of a micronized RBN-2397 tablet versus the standard RBN-2397 tablet manufactured with unmicronized RBN-2397 and used in the dose escalation phase of the study will be performed as part of the dose escalation phase Micronized tablets will be used in the Dose Expansion Phase of the study after the relative bioavailability assessment has been completed
Dose Expansion Phase The recommended phase 2 dose will be investigated in the following cancer types squamous cell carcinoma of the lung SCCL head and neck squamous cell carcinoma HNSCC hormone receptor positive HR breast cancer and PARP7 amplified cancer
Duration of treatment
It is anticipated that the minimum study involvement will be one cycle Participants are eligible to have an indefinite number of additional cycles of treatment if their disease does not progress and they do not have unacceptable side effects
Evaluate the safety profile and MTD of RBN-2397 administered orally and establish the RBN-2397 doses and schedules recommended for further investigation in Phase 2
Characterize the PK profile of RBN-2397
Identify preliminary antitumor activity
Biomarkers and their correlation with response to RBN-2397 and other outcomes will be examined
Cohorts will follow a traditional 3 3 design After enrollment of the first participant within a cohort there must be a wait period of at least 1 week before enrollment of additional participants in that cohort This dose escalation phase of the study is complete
The study is currently in the Relative Bioavailability and Expansion Cohorts phase where approximately 20 participants each will be enrolled to further examine the safety PK pharmacodynamics and antitumor activity of RBN-2397 at the recommended phase 2 dose
Relative Bioavailability Assessment
An evaluation of relative bioavailability of a micronized RBN-2397 tablet versus the standard RBN-2397 tablet manufactured with unmicronized RBN-2397 and used in the dose escalation phase of the study will be performed as part of the dose escalation phase Micronized tablets will be used in the Dose Expansion Phase of the study after the relative bioavailability assessment has been completed
Dose Expansion Phase The recommended phase 2 dose will be investigated in the following cancer types squamous cell carcinoma of the lung SCCL head and neck squamous cell carcinoma HNSCC hormone receptor positive HR breast cancer and PARP7 amplified cancer
Duration of treatment
It is anticipated that the minimum study involvement will be one cycle Participants are eligible to have an indefinite number of additional cycles of treatment if their disease does not progress and they do not have unacceptable side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None