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RecruitingLast updated: 17 November 2023

This study is evaluating the safety of a new oral drug (called GDC-1971) when it is given in combination with targeted therapy (either osimertinib or cetuximab) in people with advanced or metastatic non-small cell lung cancer, or metastatic colorectal cancerA 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

Clinical summary

Summary

This study has two stages (Dose Finding and Dose Expansion) and is recruiting two cohorts of people: people with advanced, inoperable or metastatic non-small cell lung cancer, and people with metastatic colorectal cancer.

Stage One: Dose Finding

Participants with non-small cell lung cancer will receive the experimental drug (called GDC-1971) at an assigned dose, orally, once daily, on Days 1 to 28 of each 28-day cycle, in combination with targeted therapy (caleld osimertinib) at a dose of 80mg oraly, once daily, on Days 1 to 28 of each cycle.

Participants with colorectal cancer will receive the experimental drug GDC-1971 at an assigned dose, orally, once daily, on Day 1 to 28 of each 28-day cycle in combination with targeted therapy (called cetuximab) at a dose of 500mg/m^2 given by intravenous (IV) infusion on Days 1 and 15 of each cycle.

Stage Two: Dose Expansion

Participants with non-small cell lung cancer will receive GDC-1971 at a dose determined in the Dose Finding stage, orally once daily, on Days 1 to 28 of each 28-day cycle, in combination with osimertinib at a dose of 80mg, orally once daily on Days 1 to 28 of each cycle.

Participants with colorectal cancer will receive GDC-1971 at a dose determined in the Dose Finding stage, orally once daily on Days 1 to 28 of each 28-day cycle, in combination with cetuximab at a dose of 500mg/m^2 given by IV infusion on Days 1 and 15 of each cycle.

Conditions

This trial is treating patients with unresectable, locally advanced or metastatic non-small cell lung cancer, and metastatic colorectal cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Genentech, Inc.

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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