A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
Purpose
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 months. 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.
Condition
- Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum. - Surgical tumor material should be available and must be submitted for Signatera personalized panel and assessment of c-Met protein levels. - Must have received at least 3 months of platinum-based doublet adjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy. - Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing. - Circulating tumor deoxyribonucleic acid (ctDNA) positive after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA is confirmed (reported). - For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy. - For participants with oligometastatic disease a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet therapy must have been administered.
Exclusion Criteria
- No availability of surgical tissue sample. - History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Telisotuzumab Adizutecan Monotherapy |
Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration. |
|
|
Active Comparator Standard of Care (SOC) |
Participants will receive SOC, during the approximately 51 month study duration. |
|
Recruiting Locations
Fullerton 5351247, California 5332921 92835-3826
Los Angeles 5368361, California 5332921 90033
Chicago 4887398, Illinois 4896861 60637
Baltimore 4347778, Maryland 4361885 21287
Ann Arbor 4984247, Michigan 5001836 48109-5000
Minneapolis 5037649, Minnesota 5037779 55404
Rochester 5043473, Minnesota 5037779 55905
Lake Success 5123853, New York 5128638 11042
Portland 5746545, Oregon 5744337 97227-1800
Nashville 4644585, Tennessee 4662168 37203
Austin 4671654, Texas 4736286 78705
Grapevine 4694568, Texas 4736286 76051
Houston 4699066, Texas 4736286 77030
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22031
More Details
- Status
- Recruiting
- Sponsor
- AbbVie