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Phase I

A Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Patients With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Patients With Metastatic Colorectal Cancer

  • Study HIC#:2000035345
  • Last Updated:04/14/2024

The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Eligibility Criteria

    Inclusion Criteria:

    • Evaluable or measurable disease per RECIST v1.1
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Life expectancy of ≥12 weeks
    • Adequate hematologic and organ function within 14 days prior to initiation of study Inclusion Criteria for Non-Small Cell Lung Cancer Cohorts
    • 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
    • Negative for acquired on-target EGFR alterations Inclusion Criteria for Colorectal Cancer Cohorts
    • 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

    Exclusion Criteria:

    • 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

    Other protocol-defined inclusion/exclusion criteria may apply.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: