Study to Assess Adverse Events and How Intravenously (IV) Infused ABBV-400 Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer
NCT Number: NCT06464692
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Colorectal Cancer
Interventions: DRUG: ABBV-400
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-29
Completion Date: 2027-04-05

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 ABBV-400 moves through the body of adult participants with unresectable locally advanced/metastatic CRC.

ABBV-400 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 ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Up to approximately 27 adult participants with unresectable locally advanced/metastatic CRC, will be enrolled in the study in approximately 10 sites in China.

In the dose escalation arms, participants will receive escalating doses of intravenously (IV) infused ABBV-400 dose A or B. In dose expansion arm part 1, participants will receive the optimal dose of IV infused ABBV-400. In dose expansion arm part 2, participants will receive the dose B of IV infused ABBV-400. 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.

Primary Outcome Measures: Dose-Limiting Toxicity (DLT) of ABBV-400 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., Up to 24 Months|Maximum observed plasma or serum concentration (Cmax) of ABBV-400 Conjugate, Cmax of ABBV-400 conjugate., Up to 24 Months|Time to Cmax (Tmax) of ABBV-400 Conjugate, Tmax of ABBV-400 conjugate., Up to 24 Months|Area Under the Concentration-Time Curve (AUC) of ABBV-400 Conjugate, AUC of ABBV-400 conjugate., Up to 24 Months|Total Antibody of ABBV-400, Total antibody of ABBV-400., Up to 24 Months|Unconjugated Payload of ABBV-400, Unconjugated payload of ABBV-400., Up to 24 Months
Secondary Outcome Measures: 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., Up to 24 Months|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., Up to 24 Months|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., Up to 24 Months|Progression-Free Survival (PFS), PFS as assessed by Investigator: PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause, whichever occurs first., Up to 24 Months|Overall Survival (OS), OS is defined as the time from the participant's first dose of study drug until death from any cause., Up to 24 Months