Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

Summary

This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.

Interventions

• Elironrasib · DRUG

  oral tablets

• Daraxonrasib · DRUG

  oral tablets

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 18 years of age
* Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

  1. Phase 1b Dose Escalation: solid tumors, previously treated
  2. Phase 1b Dose Expansion and Phase 2:

  i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
* ECOG performance status 0 or 1
* Adequate organ function

Exclusion Criteria:

* Primary central nervous system (CNS) tumors
* Active brain metastases
* Known impairment of GI function that would alter the absorption
* Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment

Sites (55)

• City of Hope, Duarte, California · WITHDRAWN
• UC IRVINE Health, Orange, California · RECRUITING
• UC Davis Comprehensive Cancer Center, Sacramento, California · RECRUITING
• Stanford Cancer Institute, Stanford, California · RECRUITING
• University of Colorado Cancer Center, Aurora, Colorado · RECRUITING
• Florida Cancer Specialists, Sarasota, Florida · RECRUITING
• Moffitt Cancer Center and Research Institute, Tampa, Florida · RECRUITING
• Community Health Network, Indianapolis, Indiana · RECRUITING
• Dana Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• Henry Ford Cancer, Detroit, Michigan · WITHDRAWN
• START Midwest, Grand Rapids, Michigan · RECRUITING
• Columbia University, New York, New York · RECRUITING
• NYU Langone Health, New York, New York · RECRUITING
• Memorial Sloan Kettering Cancer Center, New York, New York · RECRUITING
• University of Oklahoma, Oklahoma City, Oklahoma · RECRUITING
• Allegheny Health Network, Pittsburgh, Pennsylvania · RECRUITING
• Sarah Cannon Research Institue, Nashville, Tennessee · RECRUITING
• Mary Crowley Cancer Research, Dallas, Texas · COMPLETED
• MD Anderson, Houston, Texas · RECRUITING
• NEXT Dallas, Irving, Texas · RECRUITING
• NEXT Oncology San Antonio, San Antonio, Texas · RECRUITING
• START Texas, San Antonio, Texas · RECRUITING
• NEXT Oncology Virginia, Fairfax, Virginia · RECRUITING
• West Cancer Institute, Angers, France · RECRUITING
• Institut Bergonie, Bordeaux, France · RECRUITING
• Hospital Louise Pradel, Bron, France · RECRUITING
• Oscar Lambret Center of Lillle, Lille, France · RECRUITING
• Centre Leon Berard, Lyon, France · RECRUITING
• Cancer Institute of Montpellier, Montpellier, France · RECRUITING
• CHU Nantes, Nantes, France · RECRUITING
• Institute of Cancer of Strasbourg, Strasbourg, France · WITHDRAWN
• Universitäts Klinikum Köln, Cologne, Germany · RECRUITING
• Klinikum Esslingen GmbH, Esslingen am Neckar, Germany · RECRUITING
• Krankenhaus Bethanien Moers, Moers, Germany · RECRUITING
• Klinkum Nurnberg Paracelsus Medical Unviersity, Nuremberg, Germany · RECRUITING
• Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche, Ancona, Italy · RECRUITING
• Centro Di Riferimento Oncologico, Aviano, Italy · RECRUITING
• Institute Romagnolo per lo Studio Tumori, Meldola, Italy · RECRUITING
• Niguarda Cancer Center, Milan, Italy · RECRUITING
• Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale", Naples, Italy · RECRUITING
• San Luigi Hospital, Orbassano, Italy · RECRUITING
• AUSL Romagna - S.M. delle Croci Hospital, Ravenna, Italy · RECRUITING
• Netherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, Netherlands · RECRUITING
• Pan American Center for Oncology Trials, San Juan, Puerto Rico · RECRUITING
• START Barcelona - Hospital HM Nou Delfos, Barcelona, Spain · RECRUITING
• Institut Catala d'Oncologia Hospital, Barcelona, Spain · RECRUITING
• University Clinic of Navarra, Madrid, Spain · RECRUITING
• Fundacion MD Anderson Cancer Center, Madrid, Spain · RECRUITING
• START Madrid, Madrid, Spain · RECRUITING
• Hospital Universitario 12 de Octubre, Madrid, Spain · RECRUITING
• NEXT Oncology - Quirónsalud Madrid University Hospital, Madrid, Spain · RECRUITING
• University Clinic of Navarra, Pamplona, Spain · RECRUITING
• Hospital Universitario Virgen Macarena, Seville, Spain · RECRUITING
• La Fe University and Polytechnic Hospital, Valencia, Spain · RECRUITING
• Hospital Universitario Miguel Servet, Zaragoza, Spain · RECRUITING