Recruiting
Phase 1

RBN-2397

Sponsor:

Ribon Therapeutics, Inc.

Code:

NCT04053673

Conditions

Solid Tumor, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RBN-2397

Study Details

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 "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.

Conditions

Solid Tumor, Adult

Study ID

NCT04053673

Start date

Aug 1, 2019

Status verified date

Jul, 2022

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Dose Expansion Phase Only: Patients with locally advanced or metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have received standard therapy or are intolerant of standard therapy, have progressed following their last prior therapy, and have one of the following tumor types:

  • SCCL: Histologically confirmed NSCLC of predominantly squamous cell histology and must have received no more than 3 lines of prior systemic therapy including chemotherapy regimens and/or immune checkpoint inhibitor therapy (combination allowed).
  • HNSCC: Histologically confirmed squamous cell carcinoma of the head and neck (either HPV-positive or -negative) and must have received no more than 3 lines of prior systemic immunotherapy and/or chemotherapeutic treatments in the metastatic setting. Includes primary tumor location of the oral cavity, oropharynx, hypopharynx, larynx, and paranasal sinuses (nasopharyngeal carcinoma, skin squamous cell carcinoma, and salivary gland carcinomas are not eligible).
  • HR+ breast cancer: Histologically confirmed diagnosis of estrogen receptor (ER) and/or progesterone receptor (PR) positive, HER2-negative adenocarcinoma of breast (as per local laboratory testing) whose disease has failed standard systemic therapy for locally advanced or metastatic disease and must have received no more than 1 prior chemotherapeutic for advanced/metastatic disease.
  • PARP7 amplified: Tumor with documented PARP7 (or TIPARP) gene copy amplification as determined by a CLIA certified laboratory test (e.g., FoundationOne CDx) that has failed standard systemic therapy for locally advanced or metastatic disease.

Must agree to undergo tumor biopsy Normal organ and bone marrow function Patient and his/her partner agree to use adequate contraception during and for 3 months after the last study drug dose

Exclusion Criteria:

  • Unable to swallow oral medications
  • Major surgery within 4 weeks of starting study
  • Pregnant or breast-feeding.
  • Receiving intravenous antibiotics for an active infection
  • Known human immunodeficiency virus (HIV) or hepatitis B or C infection.
  • History of a different malignancy unless disease-free for at least 5 years
  • Some medications are not allowed while on study. Interested participants will need to inform study doctor of all the medications he/she is taking.
  • Herbal medicines, and grapefruit, grapefruit juice, pomegranate juice, star fruit or orange marmalade (made with Seville oranges) are not allowed to be taken during study.

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RBN-2397

Dose Escalation: Multiple doses of RBN-2397 for oral administration Dose Expansion: Oral dose of RBN-2397 as determined during Dose Escalation

Interventions

RBN-2397

an oral PARP7 Inhibitor

Primary outcome measure

  • Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [ Time Frame: through first treatment cycle (an average of 21 days) ]

Central Contacts and Locations

Central contacts

Clinical Operations Manager

617-475-7203clinicaltrials@ribontx.com

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Aaron Parsons

720-848-4603aaron.parsons@cuanschutz.edu

Principal Investigator:

Erin Schenk, MD

SCRI-Denver/HealthOne

Recruiting

Denver, Colorado, United States, 80218

Contacts

Gerald Falchook, MD

281-221-0693Gerald.Falchook@SarahCannon.com

Principal Investigator:

Gerald Falchook, MD

Yale Cancer Center, Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Kwasi Boateng

203-785-6993kwasi.boateng@yale.edu

Principal Investigator:

Barbara Burtness, MD

Sarah Cannon Research Institute at Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Contacts

Cesar Augusto Perez Batista, MD

689-216-8500Cesar.PerezBatista@flcancer.com

Principal Investigator:

Cesar Augusto Perez Batista, MD

SCRI-Sarasota/Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Manish Patel, MD

941-377-9993mpatel@flcancer.com

Principal Investigator:

Manish Patel, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alicia Bilsky

617-643-5965abilsky@mgh.harvard.edu

Principal Investigator:

Dejan Juric, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

James McCoy

617-632-5485James_McCoy@DFCI.HARVARD.EDU

Principal Investigator:

Geoffrey Shapiro, MD

Washington University

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Maximilian Stroyeck

314-253-2027stroyeck@wustl.edu

Principal Investigator:

Saima Waqar, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Amy Rose

kennaj@UPMC.EDU

Principal Investigator:

Yana Najjar, MD

SCRI-Nashville/Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Melissa Johnson, MD

615-329-7274mjohnson@tnonc.com

Principal Investigator:

Melissa L. Johnson, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Contacts

Timothy A Yap, MD, PhD

713-563-1784tyap@mdanderson.org

Principal Investigator:

Timothy A Yap, MD, PhD

More Information

Sponsor

Ribon Therapeutics, Inc.

Last update posted

Mar 28, 2023

Last verified

Jul, 2022

Keywords

  • Phase 1
  • PARP7 inhibition
  • First in Human
  • Solid Tumors
  • Interferon

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ribon Therapeutics, Inc. on 2023-03-28.