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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Cervical Cancer
  • Colorectal Neoplasms
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Gastric Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Malignant Pleural Mesothelioma (MPM)
  • Mesothelioma
  • Mesothelioma, Malignant
  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • Metastatic or Unresectable Melanoma
  • Metastatic Urothelial Carcinoma
  • Microsatellite Stable Colorectal Carcinoma
  • Neoplasms
  • Non-small Cell Lung Cancer (NSCLC)
  • Ovarian Cancer, Epithelial
  • Richter Transformation
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Cancer (TNBC)
  • Triple Negative Breast Neoplasms

NCT number NCT05107674
Study type Interventional
Source Nurix Therapeutics, Inc.
Contact Nurix Therapeutics Patient Outreach
Phone 4152307815
Email nx1607101@nurixtx.com
Status Recruiting
Phase Phase 1
Start date September 29, 2021
Completion date February 28, 2026

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