Clinical Trial 23990

• Overview

  Study Title:

  AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer

  Summary:

  Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 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.

  Objective:

  Primary Objectives: *To demonstrate the superiority of telisotuzumab adizutecan + bevacizumab over trifluridine and tipiracil + bevacizumab in terms of OR *To demonstrate the superiority of telisotuzumab adizutecan + bevacizumab over trifluridine and tipiracil + bevacizumab in terms of OS Secondary Objectives: *To evaluate the efficacy as measured by progression-free survival (PFS) of telisotuzumab adizutecan + bevacizumab in subjects with unresectable refractory mCRC. *To evaluate the impact of telisotuzumab adizutecan + bevacizumab on key PROs by assessing physical functioning and overall QoL from the subject's perspective. *To evaluate the safety of telisotuzumab adizutecan + bevacizumab in subjects with unresectable refractory mCRC. *To evaluate clinical outcomes such as duration of response (DoR) and disease control (DC) of telisotuzumab adizutecan + bevacizumab in subjects with unresectable refractory mCRC.

• Treatments

  Therapies:

  Antibody-Drug Conjugate; Chemotherapy (NOS); VEGF inhibitor monoclonal antibody

  Medications:

  Avastin (Bevacizumab); Bevacizumab (); Telisotuzumab Adizutecan (); Trifluridine + Tipiracil ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
  • Life expectancy >= 12 weeks per investigator assessment.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent.
  • History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
  • History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
  • History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

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