Clinical Trials List
Protocol NumberM26-120
Not yet recruiting
2026-08-01 - 2030-02-28
Phase II
Not yet recruiting1
A phase 2 open-label, randomized trial was conducted to evaluate the safety, efficacy, and optimal dosage of telisotuzumab adizutecan in combination with pembrolizumab as first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
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Trial Applicant
AbbVie
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Sponsor
AbbVie Pharmaceuticals Ltd. Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/11
Investigators and Locations
Co-Principal Investigator
- Chen-Yuan Lin 無
- Ching-Chan Lin 無
- Yu-Min Liao 無
- 陳珈妤 無
Co-Principal Investigator
- 王閔宏 無
- Tsung-Jang Yeh 無
- Jeng-Shiun Du 無
- 謝子禹 無
- 許瑞峰 無
Co-Principal Investigator
- 楊明翰 無
- 黃彥霖 無
- RUEY-LONG HONG 無
- Hsiang-Fong Kao 無
- 廖斌志 無
- YA-FANG CHEN 無
Co-Principal Investigator
Principal Investigator
Hung-Ming Wang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Head and neck squamous cell carcinoma
Objectives
The primary objective of this trial is to determine whether the combination of telisotuzumab adizutecan (the investigational drug) and pembrolizumab (another approved cancer drug) is safe and effective as first-line treatment for patients with recurrent or metastatic head and neck cancer. The trial aims to understand whether this new combination therapy is more effective and safer than current treatments.
Test Drug
Pembrolizumab
Telisotuzumab Adizutecan
Telisotuzumab Adizutecan
Active Ingredient
Pembrolizumab
Telisotuzumab Adizutecan
Telisotuzumab Adizutecan
Dosage Form
N/A
N/A
N/A
Dosage
N/A
N/A
N/A
Endpoints
- Evaluate the safety and tolerability of telisotuzumab adizutecan combined with pembrolizumab.
- Determine the optimal dose of telisotuzumab adizutecan combined with pembrolizumab and select the recommended dose for Phase 3 (RP3D).
- Assess efficacy using objective response (OR) and progression-free survival (PFS) of telisotuzumab adizutecan combined with pembrolizumab.
- Determine the optimal dose of telisotuzumab adizutecan combined with pembrolizumab and select the recommended dose for Phase 3 (RP3D).
- Assess efficacy using objective response (OR) and progression-free survival (PFS) of telisotuzumab adizutecan combined with pembrolizumab.
Inclution Criteria
- Must be histologically or cytologically confirmed as R/M HNSCC originating from the oral cavity, oropharynx, hypopharynx, or larynx, and deemed incurable by local treatment.
- ECOG performance status must be ≤1.
- Central c-Met IHC staining must show ≥25% of tumor cells with c-Met protein expression of ≥1+ (any) intensity.
- Must have at least one measurable disease as defined in RECIST version 1.1.
- Must not have previously received systemic therapy for recurrent/metastatic head and neck squamous cell carcinoma.
- ECOG performance status must be ≤1.
- Central c-Met IHC staining must show ≥25% of tumor cells with c-Met protein expression of ≥1+ (any) intensity.
- Must have at least one measurable disease as defined in RECIST version 1.1.
- Must not have previously received systemic therapy for recurrent/metastatic head and neck squamous cell carcinoma.
Exclusion Criteria
- History of interstitial lung disease or pneumonia requiring systemic steroid treatment, or screening chest CT scan showing evidence of any active interstitial lung disease or pneumonia.
- Any serious, life-threatening medical condition.
- Life expectancy should be at least 3 months.
- Any serious, life-threatening medical condition.
- Life expectancy should be at least 3 months.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
150 participants
