Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Evaluable or measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of ≥12 weeks
Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the lung that has progressed on/after prior treatment with third-generation epidermal growth factor receptor (EGFR) inhibitor (e.g., osimertinib)
Positive for an EGFR exon 19 deletion or exon 21 L858R mutation
Histologically confirmed metastatic adenocarcinoma of the colon or rectum that has progressed on/after prior treatment with an EGFR inhibitor (e.g., cetuximab or panitumumab)
Negative for kirsten rat sarcoma viral oncogene homolog (KRAS) alterations
Negative for neuroblastoma RAS viral oncogene homolog (NRAS) alterations
Negative for proto-oncogene B-Raf (BRAF) V600E alterations
In lieu of a fresh pre-treatment biopsy, a recently obtained biopsy performed after completion of osimertinib therapy will be acceptable
You may not be if
Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 3 weeks or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study treatment
Treatment with endocrine therapy within 2 weeks prior to initiation of study drug, except for hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for endocrine-sensitive cancers
Significant traumatic injury or major surgical procedure within 4 weeks prior to Cycle 1, Day 1
Positive hepatitis C virus (HCV) antibody test at screening
Positive hepatitis B surface antigen (HBsAg) test at screening
Known HIV infection
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Uncontrolled hypercalcemia
Substance abuse, as determined by the investigator, within 12 months prior to screening
Poor peripheral venous access
Inability or unwillingness to swallow pills
Malabsorption syndrome or other condition that would interfere with enteral absorption Chronic diarrhea, short bowel syndrome, or significant upper GI surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)
Serious infection within 4 weeks prior to screening
History of malignancy within 3 years prior to screening
Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Leptomeningeal disease or carcinomatous meningitis
History or presence of an abnormal electrocardiogram (ECG) that is deemed clinically significant by the investigator (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence of prior myocardial infarction
Left ventricular ejection fraction (LVEF) less than the institutional lower limit of normal (LLN) or \<50%
History or evidence of ophthalmic disease
History of or active clinically significant cardiovascular dysfunction
History of pulmonary firbrosis, organizing pneumonia, or pneumonitis
Clareo Health | Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer
