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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2028-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Safety Run-In Cohort 1: Telisotuzumab Adizutecan Dose A

Participants with unresectable locally advanced/metastatic colorectal cancer (CRC) will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration.

Group Type EXPERIMENTAL

Telisotuzumab Adizutecan

Intervention Type DRUG

Intravenous (IV) Infusion

Safety Run-In Cohort 2: Telisotuzumab Adizutecan Dose B

Participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose B during the approximately 2.5 year study duration.

Group Type EXPERIMENTAL

Telisotuzumab Adizutecan

Intervention Type DRUG

Intravenous (IV) Infusion

Dose Expansion Part 1: Telisotuzumab Adizutecan Dose A

Participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration.

Group Type EXPERIMENTAL

Telisotuzumab Adizutecan

Intervention Type DRUG

Intravenous (IV) Infusion

Dose Expansion Part 2: Telisotuzumab Adizutecan Dose C

If further analysis is warranted, participants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose C during the approximately 2.5 year study duration.

Group Type EXPERIMENTAL

Telisotuzumab Adizutecan

Intervention Type DRUG

Intravenous (IV) Infusion

Interventions

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Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Intervention Type DRUG

Eligibility Criteria

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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%).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No