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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05954871




Registration number
NCT05954871
Ethics application status
Date submitted
12/07/2023
Date registered
20/07/2023
Date last updated
26/06/2024

Titles & IDs
Public 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
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
Secondary ID [1] 0 0
2022-502530-10-00
Secondary ID [2] 0 0
GO44272
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GDC-1971
Treatment: Drugs - Osimertinib
Treatment: Drugs - Cetuximab

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.

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.

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.

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.


Treatment: Drugs: GDC-1971
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.

Treatment: Drugs: Osimertinib
Osimertinib tablets will be administered as specified in each treatment arm.

Treatment: Drugs: Cetuximab
Cetuximab, solution for infusion will be administered as specified in each treatment arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Timepoint [1] 0 0
Up to approximately 41 months
Primary outcome [2] 0 0
Number of Participants with Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Day 1 through Day 28 of Cycle 1 (1cycle= 28 days)
Secondary outcome [1] 0 0
Plasma Concentration of GDC-1971
Timepoint [1] 0 0
Up to approximately 41 months
Secondary outcome [2] 0 0
Plasma Concentration of Osimertinib
Timepoint [2] 0 0
Up to approximately 41 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Timepoint [3] 0 0
Up to approximately 41 months
Secondary outcome [4] 0 0
Duration of Response (DOR) as Determined by Investigator According to RECIST v1.1
Timepoint [4] 0 0
Up to approximately 41 months
Secondary outcome [5] 0 0
Progression-Free Survival (PFS) After Enrollment as Determined by Investigator According to RECIST v1.1
Timepoint [5] 0 0
Up to approximately 41 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3690 - Wodonga
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05954871
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO44272 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05954871