Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
Phase 1/2 – combined early trial
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Sponsor: Revolution Medicines, Inc.
trial.available_in:
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Overview
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.
Description
This is an open-label, multicenter, Phase 1b/2 study evaluating elironrasib and daraxonrasib, administered as monotherapy and in combination, in patients with advanced KRAS G12C-mutated solid tumors to determine the maximum tolerated dose (MTD), identify the recommended Phase 2 dose and schedule (RP2DS), and preliminarily assess antitumor activity.
The study includes a Phase 1b dose escalation and expansion of combination therapy, followed by a Phase 2 evaluation of the selected RP2DS as monotherapy and combination therapy to further assess safety and antitumor activity.
Who can participate
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
Interventions
Elironrasib
DRUG
Daraxonrasib
DRUG
Locations
53
France (8)
West Cancer Institute
Angers
Institut Bergonie
Bordeaux
Hospital Louise Pradel
Bron
Oscar Lambret Center of Lillle
Lille
Centre Leon Berard
Lyon
Cancer Institute of Montpellier
Montpellier
CHU Nantes
Nantes
Institute of Cancer of Strasbourg
Strasbourg
WITHDRAWN
Germany (4)
Universitäts Klinikum Köln
Cologne
Klinikum Esslingen GmbH
Esslingen am Neckar
Krankenhaus Bethanien Moers
Moers
Klinkum Nurnberg Paracelsus Medical Unviersity
Nuremberg
Italy (7)
Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche
Ancona
Centro Di Riferimento Oncologico
Aviano
Institute Romagnolo per lo Studio Tumori
Meldola
Niguarda Cancer Center
Milan
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Naples
San Luigi Hospital
Orbassano
AUSL Romagna - S.M. delle Croci Hospital
Ravenna
Netherlands (1)
Netherlands Cancer Institute Antoni van Leeuwenhoek
Amsterdam
Puerto Rico (1)
Pan American Center for Oncology Trials
San Juan
Spain (11)
START Barcelona - Hospital HM Nou Delfos
Barcelona
Institut Catala d'Oncologia Hospital
Barcelona
University Clinic of Navarra
Madrid
Fundacion MD Anderson Cancer Center
Madrid
START Madrid
Madrid
Hospital Universitario 12 de Octubre
Madrid
NEXT Oncology - Quirónsalud Madrid University Hospital
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