Experimental combo targets tough cancers in early trial
NCT ID NCT05954871
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested an experimental drug called GDC-1971 combined with either osimertinib (for lung cancer) or cetuximab (for colorectal cancer) in 10 people with advanced cancers that had spread. The main goal was to check safety and find the right dose. Researchers also looked at how the drug moves through the body and whether tumors shrank.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GDC-1971 (an experimental drug) combined with either osimertinib or cetuximab
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced lung or colorectal cancer who have not responded to other therapies.
- What could go wrong
- This is a very early, small Phase 1 trial with only 10 participants, focused on safety and dosing. It is not designed to prove effectiveness, and many early-stage drugs do not advance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, 05505, South Korea
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Border Medical Oncology
Wodonga, New South Wales, 3690, Australia
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SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
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START South Texas Accelerated Research Therapeutics-San Antonio
San Antonio, Texas, 78229, United States
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Seoul National University Hospital
Seoul, 03080, South Korea
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St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
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Other studies related to the condition(s) this trial covers.
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