New drug candidate targets advanced colorectal cancer in early trial
NCT ID NCT06464692
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-phase study tests an investigational drug called telisotuzumab adizutecan in about 30 Chinese adults with advanced colorectal cancer that cannot be removed by surgery. The main goals are to check safety and how the drug moves through the body. Participants receive different doses of the drug through an IV, and researchers will monitor side effects and measure drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Telisotuzumab adizutecan (ABBV-400)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced colorectal cancer that has stopped responding to standard therapies.
- What could go wrong
- This is a very early, small phase 1 study focused on safety and dosing, not on proving effectiveness. The drug may cause serious side effects like lung inflammation or low blood cell counts, and it may not shrink tumors.
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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31 people
The number who actually took part.
- Started
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Sep 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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: * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Has histologically or cytologically confirmed unresectable advanced/metastatic colorectal cancer (mCRC). * Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. * Does not harbor the BRAF V600E mutation and is not deficient mismatch repair (dMMR)+/microsatellite instability (MSI)-High. * Stage 2 only: * Archival or recently obtained tumor material must be submitted for assessment of c-Met protein levels by an AbbVie designated IHC laboratory during the pre-screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met protein expression with 3+ intensity, \>= 10% tumor cells, recently obtained biopsy material may be submitted for reassessment of c-Met protein expression with 3+ intensity, \>= 10% tumor cells. Exclusion Criteria: * History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis. * Prior systemic regimen containing c-Met protein targeting antibody (e.g., amivantamab-vmjw, ABT-700) or define: antibody-drug conjugate (ADC). Tyrosine kinase inhibitors (TKIs) of Met protein are allowed. * History of Interstitial lung disease (ILD)/pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. * History of clinically significant, intercurrent lung-specific illnesses including, but not limited to: * Underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion, dependence on supplemental oxygen, etc.) * Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) and prior pneumonectomy. * No resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade \<= 1 prior to study entry, except for neutropenia (Grade \<= 2), peripheral neuropathy (Grade \<= 2), and alopecia (any grade). * Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). * History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year Overall Survival \[OS\] rate \> 90%).
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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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Beijing Cancer Hospital /ID# 263297
Beijing, Beijing Municipality, 100142, China
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First Affiliated Hospital of China Medical University /ID# 263338
Shenyang, Liaoning, 110001, China
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Harbin Medical University Cancer Hospital /ID# 263049
Harbin, Heilongjiang, 150081, China
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Henan Cancer Hospital /ID# 263172
Zhengzhou, Henan, 450008, China
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Hubei Cancer Hospital /ID# 263248
Wuhan, Hubei, 430079, China
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The First Affiliated Hospital of Nanchang University /ID# 263193
Nanchang, Jiangxi, 330006, China
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The Second Affiliated Hospital of College of Medicine - Zhejiang University /ID# 263094
Hangzhou, Zhejiang, 310000, China
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The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 263309
Guangzhou, Guangdong, 510655, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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