Phase 1 Study of RBN-2397, an Oral PARP7 Inhibitor, in Patients With Solid Tumors

Status unconfirmed · Phase 1

Conditions studied: Solid Tumor, Adult

In brief

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.

Key facts

Study ID

NCT04053673

Run by

Ribon Therapeutics, Inc.

People needed

130

Starts

2019-08-01

Expected to finish

2023-07-31

Last updated by the study team

2023-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• SCRI-Denver/HealthOne — Denver, Colorado, United States (enrolling)
• Yale Cancer Center, Yale University — New Haven, Connecticut, United States (enrolling)
• Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando, Florida, United States (enrolling)
• SCRI-Sarasota/Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• SCRI-Nashville/Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Hospital Quironsalud Barcelona - NEXT Oncology — Barcelona, Spain (enrolling)
• Vall d'Hebron — Barcelona, Spain (enrolling)
• Hospital Quironsalud Madrid - NEXT Oncology — Madrid, Spain (enrolling)
• Hospital Clinic Universitario Biomedical Research institute INCLIVA — Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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