search
Back to results

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

Primary Purpose

Colorectal Cancer, Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GDC-1971
Osimertinib
Cetuximab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • START South Texas Accelerated Research Therapeutics-San AntonioRecruiting
  • St Vincents HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)

Dose-Finding Stage: Colorectal Cancer (CRC)

Dose Expansion Stage: NSCLC

Dose Expansion Stage: CRC

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Number of Participants with Dose-Limiting Toxicities (DLTs)

Secondary Outcome Measures

Plasma Concentration of GDC-1971
Plasma Concentration of Osimertinib
Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Duration of Response (DOR) as Determined by Investigator According to RECIST v1.1
Progression-Free Survival (PFS) After Enrollment as Determined by Investigator According to RECIST v1.1

Full Information

First Posted
July 12, 2023
Last Updated
October 13, 2023
Sponsor
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05954871
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose-Finding Stage: Colorectal Cancer (CRC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion Stage: NSCLC
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion Stage: CRC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GDC-1971
Other Intervention Name(s)
RO7517834, RLY-1971
Intervention Description
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Intervention Type
Drug
Intervention Name(s)
Osimertinib
Intervention Description
Osimertinib tablets will be administered as specified in each treatment arm.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab, solution for infusion will be administered as specified in each treatment arm.
Primary Outcome Measure Information:
Title
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
Title
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame
Day 1 through Day 28 of Cycle 1 (1cycle= 28 days)
Secondary Outcome Measure Information:
Title
Plasma Concentration of GDC-1971
Time Frame
Up to approximately 41 months
Title
Plasma Concentration of Osimertinib
Time Frame
Up to approximately 41 months
Title
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
Title
Duration of Response (DOR) as Determined by Investigator According to RECIST v1.1
Time Frame
Up to approximately 41 months
Title
Progression-Free Survival (PFS) After Enrollment as Determined by Investigator According to RECIST v1.1
Time Frame
Up to approximately 41 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GO44272 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
START South Texas Accelerated Research Therapeutics-San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
St Vincents Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

We'll reach out to this number within 24 hrs