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

NCT06464692 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: M24-559
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; CRC; Telisotuzumab Adizutecan (ABBV-400); Unresectable Locally Advanced/Metastatic CRC

Outcome Measures

Primary Outcomes (6)

• Dose-Limiting Toxicity (DLT) of Telisotuzumab Adizutecan in Stage 1

  DLTs are defined as grade \>= 3 thrombocytopenia that cannot clinically improve after adequate medical treatment/support, febrile neutropenia grade \>= 3 or grade 4 neutropenia that cannot clinically improve after adequate medical treatment/support, and any grade 2 or higher interstitial lung disease (ILD)/pneumonitis that cannot clinically improve after adequate medical treatment/support.

  Up to 24 Months

• Maximum observed plasma or serum concentration (Cmax) of Telisotuzumab Adizutecan Conjugate

  Cmax of telisotuzumab adizutecan conjugate.

  Up to 24 Months

• Time to Cmax (Tmax) of Telisotuzumab Adizutecan Conjugate

  Tmax of telisotuzumab adizutecan conjugate.

  Up to 24 Months

• Area Under the Concentration-Time Curve (AUC) of Telisotuzumab Adizutecan Conjugate

  AUC of telisotuzumab adizutecan conjugate.

  Up to 24 Months

• Total Antibody of Telisotuzumab Adizutecan

  Total antibody of telisotuzumab adizutecan.

  Up to 24 Months

• Unconjugated Payload of Telisotuzumab Adizutecan

  Unconjugated payload of telisotuzumab adizutecan.

  Up to 24 Months

Secondary Outcomes (5)

• Objective Response (OR)

  Up to 24 Months

• Duration of Response (DoR)

  Up to 24 Months

• Best Overall Response (BOR)

  Up to 24 Months

• Progression-Free Survival (PFS)

  Up to 24 Months

• Overall Survival (OS)

  Up to 24 Months

Study Arms (4)

Safety Run-In Cohort 1: Telisotuzumab Adizutecan Dose A

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Safety Run-In Cohort 2: Telisotuzumab Adizutecan Dose B

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Dose Expansion Part 1: Telisotuzumab Adizutecan Dose A

EXPERIMENTAL

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

Drug: Telisotuzumab Adizutecan

Dose Expansion Part 2: Telisotuzumab Adizutecan Dose C

EXPERIMENTAL

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.

Drug: Telisotuzumab Adizutecan

Interventions

Telisotuzumab Adizutecan DRUG

Intravenous (IV) Infusion

Dose Expansion Part 1: Telisotuzumab Adizutecan Dose A; Dose Expansion Part 2: Telisotuzumab Adizutecan Dose C; Safety Run-In Cohort 1: Telisotuzumab Adizutecan Dose A; Safety Run-In Cohort 2: Telisotuzumab Adizutecan Dose B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (8)

Beijing Cancer Hospital /ID# 263297

Beijing, Beijing Municipality, 100142, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 263309

Guangzhou, Guangdong, 510655, China

Location

Harbin Medical University Cancer Hospital /ID# 263049

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital /ID# 263172

Zhengzhou, Henan, 450008, China

Location

Hubei Cancer Hospital /ID# 263248

Wuhan, Hubei, 430079, China

Location

The First Affiliated Hospital of Nanchang University /ID# 263193

Nanchang, Jiangxi, 330006, China

Location

First Affiliated Hospital of China Medical University /ID# 263338

Shenyang, Liaoning, 110001, China

Location

The Second Affiliated Hospital of College of Medicine - Zhejiang University /ID# 263094

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (8)