Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-… (NCT06464692) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
China31 participantsStarted 2024-09-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-Limiting Toxicity (DLT) of Telisotuzumab Adizutecan in Stage 1
Timeframe: Up to 24 Months
2
Maximum observed plasma or serum concentration (Cmax) of Telisotuzumab Adizutecan Conjugate
Timeframe: Up to 24 Months
3
Time to Cmax (Tmax) of Telisotuzumab Adizutecan Conjugate
Timeframe: Up to 24 Months
4
Area Under the Concentration-Time Curve (AUC) of Telisotuzumab Adizutecan Conjugate