Assessing how a new drug moves through the body in advanced colorectal cancer patients

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

This study is testing a new drug for advanced colorectal cancer to see how it moves through the body and if it's safe for patients.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: amivantamab, telisotuzumab
• Locations: 8 sites (Beijing, Beijing and 7 other locations)
• Trial ID: NCT06464692 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and pharmacokinetics of telisotuzumab adizutecan, an investigational drug for unresectable locally advanced or metastatic colorectal cancer. Participants will be assigned to different treatment arms to receive escalating doses of the drug intravenously. The study consists of a dose escalation phase followed by a dose expansion phase, aiming to enroll approximately 30 adult participants across 8 sites in China. The research will assess adverse events and how the drug is processed in the body.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable locally advanced or metastatic colorectal cancer who meet specific inclusion criteria.

Not a fit: Patients with the BRAF V600E mutation or those who are deficient in mismatch repair may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced colorectal cancer.

How similar studies have performed: Other studies have shown promise with similar investigational drugs, but this specific approach is novel.

Eligibility criteria

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%).

Where this trial is running

Beijing, Beijing and 7 other locations

• Beijing Cancer Hospital /ID# 263297 — Beijing, Beijing, China (Recruiting)
• The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 263309 — Guangzhou, Guangdong, China (Recruiting)
• Harbin Medical University Cancer Hospital /ID# 263049 — Harbin, Heilongjiang, China (Recruiting)
• Henan Cancer Hospital /ID# 263172 — Zhengzhou, Henan, China (Recruiting)
• Hubei Cancer Hospital /ID# 263248 — Wuhan, Hubei, China (Recruiting)
• The First Affiliated Hospital of Nanchang University /ID# 263193 — Nanchang, Jiangxi, China (Recruiting)
• First Affiliated Hospital of China Medical University /ID# 263338 — Shenyang, Liaoning, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 263094 — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Colorectal Cancer; CRC; Telisotuzumab Adizutecan; Unresectable Locally Advanced/Metastatic CRC