OncoMatch/Clinical Trials/NCT06464692
Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-400) Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer
Is NCT06464692 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Telisotuzumab Adizutecan for colorectal cancer.
Treatment: Telisotuzumab Adizutecan — Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and how telisotuzumab adizutecan moves through the body of adult participants with unresectable locally advanced/metastatic CRC. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Study doctors put the participants in cohorts called treatment arms. Each treatment arm receives a different dose of telisotuzumab adizutecan. This study will include a dose escalation phase followed by a dose expansion phase. Up to approximately 30 adult participants with unresectable locally advanced/metastatic CRC, will be enrolled in the study in approximately 8 sites in China. In the dose escalation arms, participants will receive escalating doses of intravenously (IV) infused telisotuzumab adizutecan dose A or B. In dose expansion arm part 1, participants will receive dose A of IV infused telisotuzumab adizutecan. In dose expansion arm part 2, participants will receive the dose C of IV infused telisotuzumab adizutecan. The total study duration will be approximately 2.5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF V600E (wild-type)
Does not harbor the BRAF V600E mutation
Required: MMR deficient mismatch repair (wild-type)
is not deficient mismatch repair (dMMR)+
Required: MSI microsatellite instability-high (wild-type)
is not...microsatellite instability (MSI)-High
Required: MET overexpression (3+ intensity, >= 10% tumor cells)
assessment of c-Met protein levels...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
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: c-Met protein targeting antibody (amivantamab-vmjw, ABT-700)
Prior systemic regimen containing c-Met protein targeting antibody (e.g., amivantamab-vmjw, ABT-700)
Cannot have received: antibody-drug conjugate
Prior systemic regimen containing...antibody-drug conjugate (ADC)
Lab requirements
Cardiac function
No history (within 6 months) of congestive heart failure (NYHA Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring intervention, pericardial effusion, or pericarditis.
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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