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Clinical Trials List

Protocol NumberM24-536

NCT Number(ClinicalTrials.gov Identfier)NCT06772623

Active

2025-03-01 - 2028-03-31

Phase I/II

Recruiting8

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Trial Applicant

AbbVie
Sponsor

ABBVIE BIOPHARMACEUTICALS GMBH TAIWAN BRANCH (SWITZERLAND)
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator James Chih-Hsin Yang 無

National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良無

Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔡鎮良無

Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG 無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non Small Cell Lung Carcinoma

Objectives

The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.

Test Drug

N/A

Active Ingredient

Telisotuzumab Adizutecan (ABBV-400)

Dosage Form

Dosage

N/A

Endpoints

• To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with programmed cell death receptor 1 (PD1) immune checkpoint inhibitor
• To evaluate the optimal recommended Phase 3 dose (RP3D) of telisotuzumab adizutecan in combination
with budigalimab
• To evaluate the efficacy, as measured by objective response rate (ORR) of telisotuzumab adizutecan in
combination with budigalima

Inclution Criteria

Inclusion Criteria:
• Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.
• Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
• For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.
• For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.
• Must have documented programmed death ligand 1 (PD-L1) status.
• Must have adequate organ function.

Exclusion Criteria

Exclusion Criteria:
• Known uncontrolled metastases to the central nervous system.
• 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.

The Estimated Number of Participants

Taiwan

20 participants
Global

252 participants