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Brief Title: A Study of NX-1607 in Adults With Advanced Malignancies
Official Title: A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types
Study ID: NCT05107674
Brief Summary: This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.
Detailed Description: Phase 1a will consist of 2 study arms: Monotherapy and Paclitaxel combo. Phase 1a dose escalation will evaluate the safety and tolerability of NX-1607 in adult patients with advanced solid tumors for which standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. Indications for monotherapy include platinum resistant epithelial ovarian cancer (EOC), gastric/gastroesophageal junction (GEJ) cancer, squamous cell carcinoma of the head and neck (HNSCC), recurrent and either metastatic or unresectable melanoma, non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (mCRPC), malignant pleural mesothelioma (MPM), triple-negative breast cancer (TNBC), locally advanced or metastatic urothelial cancer, cervical cancer, and microsatellite stable colorectal cancer (MSS CRC), and diffuse large cell B-cell lymphoma (DLBCL) including patients with Richter transformation (DLBCL-RT). Indications for paclitaxel combo may include, but are not limited to, platinum-resistant EOC, gastric/GEJ cancer, HNSCC, NSCLC, TNBC, locally advanced or metastatic urothelial cancer, and cervical cancer at the Sponsor's discretion. Phase 1b will investigate the efficacy of NX-1607 as monotherapy or in combination with paclitaxel at the dose(s) selected in Phase 1a in up to 8 cohorts of patients with select advanced malignancies for which standard therapy, including immunotherapy, with proven clinical benefit does not exist, is no longer effective, or is not appropriate. Indications include platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma, advanced gastric/GEJ cancer, HNSCC, recurrent and either metastatic or unresectable melanoma, advanced NSCLC, mCRPC, mixed solid tumor cohort indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or MSS CRC, and DLBCL including patients with DLBCL-RT.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
University of Southern California, Los Angeles, California, United States
University of California, San Francisco, San Francisco, California, United States
University of Colorado School of Medicine, Aurora, Colorado, United States
University of Chicago, Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Royal Marsden Hospital NHS Foundation Trust, Sutton, Surrey, United Kingdom
University College London Hospitals NHS Foundation Trust, Bloomsbury, , United Kingdom
Addenbrookes Cambridge University Hospital, Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Northern Centre for Cancer Care, Newcastle, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Name: Paula O'Connor, MD
Affiliation: Nurix Therapeutics, Inc.
Role: STUDY_DIRECTOR