Phase 1 Study of RBN-2397, an Oral PARP7 Inhibitor, in Patients With Solid Tumors
Public ClinicalTrials.gov record NCT04053673. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 "don't 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.
Study identification
- NCT ID
- NCT04053673
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2019
- Primary completion
- Jun 29, 2023
- Completion
- Jul 30, 2023
- Last update posted
- Mar 27, 2023
2019 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | Recruiting |
| SCRI-Denver/HealthOne | Denver | Colorado | 80218 | Recruiting |
| Yale Cancer Center, Yale University | New Haven | Connecticut | 06520 | Recruiting |
| Sarah Cannon Research Institute at Florida Cancer Specialists | Orlando | Florida | 32827 | Recruiting |
| SCRI-Sarasota/Florida Cancer Specialists | Sarasota | Florida | 34232 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Washington University | St Louis | Missouri | 63110 | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| SCRI-Nashville/Tennessee Oncology | Nashville | Tennessee | 37203 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030-4009 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04053673, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 27, 2023 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04053673 live on ClinicalTrials.gov.