Clinical Trials List
Protocol NumberGO44272
NCT Number(ClinicalTrials.gov Identfier)NCT05954871
Completed
2023-12-08 - 2024-08-28
Phase I
Recruiting2
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
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- CHAO-CHI HO CHAO-CHI HO 無
- YEN-TING LIN 無
- 許嘉林 無
- Kun-Huei Yeh 無
- Chong-Jen Yu 無
- JIN-YUAN SHIH 無
- 陳國興 無
- 廖唯昱 無
- 吳尚俊 無
- 徐偉勛 無
- James Chih-Hsin Yang 無
- 廖斌志 無
- Jih-Hsiang Lee 無
- 梁逸歆 無
- 楊景堯 無
- 蔡子修 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-Chung Lin 無
- Jui-Hung Tsai 無
- Peng-Chan Lin 無
- 黃怡璇 無
- Shang-Yin Wu 無
- Shang-Hung Chen 無
- Chun-Hui Lee 無
- 黃盈慈 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Colorectal Cancer ；Non-Small Cell Lung Cancer
Objectives
This trial will evaluate GDC-1971 in combination with osimertinib in patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epithelial cell growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. patients, or combined with cetuximab for patients with metastatic rat sarcoma viral oncogene homolog (RAS)/v-raf murine sarcoma viral oncogene homolog B1 (BRAF) wild-type (WT) colorectal cancer (CRC) Safety, pharmacokinetics, and preliminary activity. The clear purpose and corresponding indicators of the test are listed below.
In this trial protocol, "investigational treatment" means the treatment combination assigned to patients as part of this trial (i.e., GDC-1971 and osimertinib, or GDC-1971 and cetuximab).
Test Drug
GDC-1971CetuximabOsimertinib
Active Ingredient
GDC-1971
Cetuximab
osimertinib
Cetuximab
osimertinib
Dosage Form
Capsule and rablet
solution for infusion
tablet
solution for infusion
tablet
Dosage
5 mg/mL
Endpoints
Assessing the safety of GDC-1971 combined with osimertinib or cetuximab
Inclution 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
-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
-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
The Estimated Number of Participants
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Taiwan
20 participants
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Global
172 participants
