A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older with Locally Advanced or Metastatic Solid Tumors that Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie INC.

External identifiers

EU CT number

2024-518871-74-00

ClinicalTrials.gov

NCT07196644

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

1. To evaluate the efficacy of telisotuzumab adizutecan monotherapy as measured by OR (objective response) in subjects with locally advanced or metastatic solid tumors that harbor MET amplification
2. To evaluate the safety and tolerability of telisotuzumab adizutecan monotherapy in subjects with locally advanced or metastatic solid tumors that harbor MET amplification

Secondary objectives 2

1. To further evaluate the efficacy of telisotuzumab adizutecan monotherapy as measured by duration of response (DoR), progression-free survival (PFS), disease control (DC), and overall survival (OS).
2. To characterize the pharmacokinetics (PK) and immunogenicity of telisotuzumab adizutecan monotherapy.

Conditions and MedDRA coding

Locally Advanced or Metastatic Solid Tumours that harbour MET Amplification gene

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Locally advanced/metastatic solid tumors with documented MET amplification via Local next generation sequencing (NGS) or Central NGS via FoundationOne Companion Diagnostic (F1CDx).
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
3. Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) criteria as appropriate to tumor type.
4. Received prior systemic therapy appropriate for their tumor type and stage of disease and who have no satisfactory alternative therapy for advanced solid tumors that would be expected to provide a substantial survival benefit for their tumor type.
5. If participant has central nervous system (CNS) metastasis, these should be clinically asymptomatic or radiologically stable (i.e., without evidence of progression after definitive treatment

Exclusion criteria 2

1. Current, historical, or suspected (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids.
2. Any major, life-threatening conditions and life expectancy should be at least 12 weeks.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)

Secondary endpoints 4

1. Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
2. Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
3. Disease Control (DC) as Assessed by ICR based on RECIST v1.1 or RANO criteria as appropriate to tumor type in subjects with MET amplified positivity determined by F1CDx testing
4. OS in Participants with MET Amplified Positivity Determined by F1CDx Testing

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 10

Locations

3 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications