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Program Status Clinical trial’s patient recruitment status
Phase Phase of the clinical trial that is recruiting (I, II, or III)
Immunotherapy-centered Trial A flag to indicate whether the trial is an immunotherapy trial
Prior Immunotherapy Allowed Whether the clinical trial is open to patients who have received prior immunotherapy
CRC-directed Trial A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Drugs Therapeutics used in the clinical trial
Tags
Comments
Combination of targeted-to-the-mutation therapy PLUS several other anti-cancer therapies (targeted therapies and chemotherapies, in the case of the arms of the trial that admit CRC patients). AMG 510: targeted therapy against the KRAS G12C mutation. Only key inclusion criteria listed in the trial record: Having a locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing. (NO mention of prior immunotherapy, prior targeted therapy, measurable or just evaluable disease, how many lines of prior therapy required, etc.) AMG 510 monotherapy: minimal activity in CRC (NCT03600883; see Helpful Links), hence the combinations tested in this trial.
Early data from this trial’s phase 1b dose exploration (n=8) and expansion (n=18) cohorts showed promising antitumor activity for the combination of Soto and panitumumab (Pmab) (see Helpful Links)
Helpful Links
Contacts
Inclusion Criteria
Inclusion Criteria:
Men or women greater than or equal to 18 years old. Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Exclusion Criteria
Exclusion Criteria:
Primary brain tumor. Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors. Myocardial infarction within 6 months of study day 1. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
NCT ID Trial ID number from clinicaltrials.gov or other database
Date Trial Added Date on which the clinical trial was added to the clinicaltrials.gov website
Updated Date Date on which the clinical trial was updated on the clinicaltrials.gov website