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Colorectal CancerPhase 1NCT06464692

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

A Phase 1 study testing Telisotuzumab Adizutecan in people with Colorectal Cancer, run by AbbVie at 8 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Telisotuzumab Adizutecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
8 sitesChina
Study dates
30 Sep 2024to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.)
Show all 10Show fewer
  • 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%).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Beijing Cancer Hospital /ID# 263297

    Beijing, Beijing Municipality, 100142

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

    Guangzhou, Guangdong, 510655

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

    Hangzhou, Zhejiang, 310000

  • Harbin Medical University Cancer Hospital /ID# 263049

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital of Nanchang University /ID# 263193

    Nanchang, Jiangxi, 330006

  • First Affiliated Hospital of China Medical University /ID# 263338

    Shenyang, Liaoning, 110001

  • Hubei Cancer Hospital /ID# 263248

    Wuhan, Hubei, 430079

  • Henan Cancer Hospital /ID# 263172

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase 1b Study to Evaluate Safety and Pharmacokinetics (PK) of Telisotuzumab Adizutecan (ABBV-400) in Chinese Subjects With Unresectable Locally Advanced/Metastatic Colorectal Cancer

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.

Read more

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.

Being tested
Telisotuzumab Adizutecan
Keywords
Colorectal Cancer, CRC, Telisotuzumab Adizutecan (ABBV-400), Unresectable Locally Advanced/Metastatic CRC
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telisotuzumab AdizutecanDrug

    Intravenous (IV) Infusion

Study groups in NCT06464692
Study groupRoleWhat they receive
Safety Run-In Cohort 1: Telisotuzumab Adizutecan Dose AExperimentalParticipants with unresectable locally advanced/metastatic colorectal cancer (CRC) will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration.
Receives: Drug: Telisotuzumab Adizutecan
Safety Run-In Cohort 2: Telisotuzumab Adizutecan Dose BExperimentalParticipants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose B during the approximately 2.5 year study duration.
Receives: Drug: Telisotuzumab Adizutecan
Dose Expansion Part 1: Telisotuzumab Adizutecan Dose AExperimentalParticipants with unresectable locally advanced/metastatic CRC will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration.
Receives: Drug: Telisotuzumab Adizutecan
Dose Expansion Part 2: Telisotuzumab Adizutecan Dose CExperimentalIf 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.
Receives: Drug: Telisotuzumab Adizutecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 Months

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

    Cmax of telisotuzumab adizutecan conjugate.

    Measured: Up to 24 Months

  3. Time to Cmax (Tmax) of Telisotuzumab Adizutecan Conjugate

    Tmax of telisotuzumab adizutecan conjugate.

    Measured: Up to 24 Months

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

    AUC of telisotuzumab adizutecan conjugate.

    Measured: Up to 24 Months

  5. Total Antibody of Telisotuzumab Adizutecan

    Total antibody of telisotuzumab adizutecan.

    Measured: Up to 24 Months

  6. Unconjugated Payload of Telisotuzumab Adizutecan

    Unconjugated payload of telisotuzumab adizutecan.

    Measured: Up to 24 Months

Secondary outcomes (5)

  1. Objective Response (OR)

    OR as assessed by the Investigator: Confirmed complete response (CR) or confirmed partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

    Measured: Up to 24 Months

  2. Duration of Response (DoR)

    DoR as assessed by Investigator: DoR is defined as the time from the participantt's initial response (CR or PR) to the first occurrence of radiographic progression or death from any cause.

    Measured: Up to 24 Months

  3. Best Overall Response (BOR)

    Disease control as assessed by the Investigator: BOR of confirmed CR or confirmed PR, or stable disease based on RECIST, version 1.1.

    Measured: Up to 24 Months

  4. Progression-Free Survival (PFS)

    PFS as assessed by Investigator: PFS is defined as the time from the participant's first dose of study treatment until radiographic progression or death from any cause, whichever occurs first.

    Measured: Up to 24 Months

  5. Overall Survival (OS)

    OS is defined as the time from the participant's first dose of study treatment until death from any cause.

    Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start30 Sep 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464692
Sponsor's protocol ID
M24-559
Status last verified
May 2026
First submitted
13 Jun 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Telisotuzumab Adizutecan in people with Colorectal Cancer, run by AbbVie at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) of Telisotuzumab Adizutecan in Stage 1 (time frame: Up to 24 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06464692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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