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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

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ClinicalTrials.gov Identifier: NCT05954871
Recruitment Status : Recruiting
First Posted : July 20, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Non-Small Cell Lung Cancer Drug: GDC-1971 Drug: Osimertinib Drug: Cetuximab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : December 15, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)
Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at an assigned dose, orally, once daily (QD), on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 milligrams (mg), orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.
 Drug: GDC-1971
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Other Name: RO7517834, RLY-1971

Drug: Osimertinib
Osimertinib tablets will be administered as specified in each treatment arm.
Experimental: Dose-Finding Stage: Colorectal Cancer (CRC)
Participants with metastatic CRC will receive GDC-1971, at an assigned dose, orally, QD, on Days 1 to 28 days of each 28-day cycle in combination with cetuximab, 500 milligrams per square meter (mg/m^2), given by IV infusion on Days 1 and 15 of each cycle, until disease progression or unacceptable toxicity.
 Drug: GDC-1971
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Other Name: RO7517834, RLY-1971

Drug: Cetuximab
Cetuximab, solution for infusion will be administered as specified in each treatment arm.
Experimental: Dose Expansion Stage: NSCLC
Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 mg, orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.
 Drug: GDC-1971
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Other Name: RO7517834, RLY-1971

Drug: Osimertinib
Osimertinib tablets will be administered as specified in each treatment arm.
Experimental: Dose Expansion Stage: CRC
Participants with metastatic CRC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with cetuximab, 500 mg/m^2, given by IV infusion on Days 1 and 15 of each cycle until disease progression or unacceptable toxicity.
 Drug: GDC-1971
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Other Name: RO7517834, RLY-1971

Drug: Cetuximab
Cetuximab, solution for infusion will be administered as specified in each treatment arm.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 [ Time Frame: Up to approximately 41 months ]
  2. Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 through Day 28 of Cycle 1 (1cycle= 28 days) ]

Secondary Outcome Measures :
  1. Plasma Concentration of GDC-1971 [ Time Frame: Up to approximately 41 months ]
  2. Plasma Concentration of Osimertinib [ Time Frame: Up to approximately 41 months ]
  3. Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). [ Time Frame: Up to approximately 41 months ]
  4. Duration of Response (DOR) as Determined by Investigator According to RECIST v1.1 [ Time Frame: Up to approximately 41 months ]
  5. Progression-Free Survival (PFS) After Enrollment as Determined by Investigator According to RECIST v1.1 [ Time Frame: Up to approximately 41 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05954871


Contacts
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Contact: Reference Study ID Number: GO44272 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
START South Texas Accelerated Research Therapeutics-San Antonio Recruiting
San Antonio, Texas, United States, 78229
Australia, Victoria
St Vincents Hospital Recruiting
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT05954871    
Other Study ID Numbers: GO44272
2022-502530-10-00 ( Other Identifier: EU Clinical Trial Number )
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Osimertinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action