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

Official title

A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects With Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)

Overview

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.

Interventions

• Drug Telisotuzumab Adizutecan
  Intravenous (IV) Infusion
• Drug Standard of Care
  Standard of care treatment based on investigator's judgement to the active surveillance.

Primary outcome measures

• Percentage of Participants with disease free survival (DFS) Event [Time frame: Up to Approximately 51 Months]

Secondary outcome measures (2)

• Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months [Time frame: 6 Months]
• Overall Survival (OS) [Time frame: Up to Approximately 51 Months]

Eligibility criteria

Inclusion criteria

• Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
• Surgical tumor material should be available for Signatera ctDNA personalized panel design.
• Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant 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 within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 22 centers

• Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621 — Huntsville
• Providence Medical Foundation - Fullerton /ID# 274207 — Fullerton
• USC Norris Comprehensive Cancer Center /ID# 274550 — Los Angeles
• Mayo Clinic Hospital Jacksonville /ID# 274472 — Jacksonville
• Moffitt Cancer Center /ID# 274372 — Tampa
• University of Chicago Medical Center /ID# 274742 — Chicago
• Johns Hopkins Hospital /ID# 275645 — Baltimore
• Massachusetts General Hospital /ID# 273608 — Boston
• … and 14 more centers

Japan · 8 centers

• Aichi Cancer Center /ID# 275479 — Nagoya
• National Cancer Center Hospital East /ID# 273614 — Kashiwa-shi
• Kyushu University Hospital /ID# 273710 — Fukuoka
• Gifu University Hospital /ID# 274179 — Gifu
• Yokohama City University Medical Center /ID# 273657 — Yokohama
• Tohoku University Hospital /ID# 275481 — Sendai
• National Hospital Organization Osaka National Hospital /ID# 274306 — Osaka
• Shizuoka Cancer Center /ID# 275480 — Sunto-gun

Belgium · 3 centers

• Cliniques Universitaires UCL Saint-Luc /ID# 278669 — Brussels
• Universitair Ziekenhuis Leuven /ID# 278668 — Leuven
• CHU de Liege /ID# 278857 — Liège

Denmark · 3 centers

• Aarhus Universitetshospital - Skejby /ID# 274498 — Aarhus
• Odense University Hospital /ID# 274970 — Odense C
• Vejle Sygehus /ID# 274368 — Vejle

Italy · 3 centers

• Azienda Ospedaliero Universitaria Careggi /ID# 273604 — Florence
• IRCCS Istituto Clinico Humanitas /ID# 273566 — Rozzano
• Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540 — Naples

South Korea · 3 centers

• Seoul National University Hospital /ID# 274451 — Seoul
• Asan Medical Center /ID# 274454 — Seoul
• Samsung Medical Center /ID# 274452 — Seoul

Spain · 3 centers

• Hospital Universitario Virgen del Rocio /ID# 273720 — Seville
• Hospital Universitario La Paz /ID# 273718 — Madrid
• Hospital Universitario de Salamanca /ID# 273719 — Salamanca

Taiwan · 3 centers

• Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745 — Kaohsiung City
• China Medical University Hospital /ID# 274644 — Taichung
• National Taiwan University Hospital /ID# 273580 — Taipei

Identifiers

NCT: NCT07023289 · M24-534 · 2024-518015-19-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗