Trial 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
NCT ID:
NCT05954871
Condition:
Colorectal Cancer
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Cetuximab
Osimertinib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GDC-1971
Description:
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Arm group label:
Dose Expansion Stage: CRC
Arm group label:
Dose Expansion Stage: NSCLC
Arm group label:
Dose-Finding Stage: Colorectal Cancer (CRC)
Arm group label:
Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)
Other name:
RO7517834, RLY-1971
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Osimertinib tablets will be administered as specified in each treatment arm.
Arm group label:
Dose Expansion Stage: NSCLC
Arm group label:
Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab, solution for infusion will be administered as specified in each treatment arm.
Arm group label:
Dose Expansion Stage: CRC
Arm group label:
Dose-Finding Stage: Colorectal Cancer (CRC)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford Advanced Medical Center
Address:
City:
Stanford
Zip:
94305
Country:
United States
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Facility:
Name:
Christiana Care Health System
Address:
City:
Newark
Zip:
19713
Country:
United States
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
START South Texas Accelerated Research Therapeutics-San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
Border Medical Oncology
Address:
City:
Wodonga
Zip:
3690
Country:
Australia
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville
Zip:
5011
Country:
Australia
Facility:
Name:
St Vincent's Hospital Melbourne
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Facility:
Name:
Peter Maccallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Facility:
Name:
British Columbia Cancer Agency
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Facility:
Name:
Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Start date:
January 8, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05954871
