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NCT07196644
A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification
Phase 2 trial testing Telisotuzumab Adizutecan in Solid Tumors Harboring MET Amplification in 100 participants. Currently enrolling.
1 December 2030
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 December 2025 |
| Primary completion | 1 December 2030 |
| Estimated completion | 1 December 2030 |
| Sites | 31 locations across United States, Israel, Japan, South Korea |
Drugs / interventions tested
- Telisotuzumab Adizutecan — full drug profile →
Conditions studied
- Solid Tumors Harboring MET Amplification — all drugs for Solid Tumors Harboring MET Amplification →
Sponsor
AbbVie — full company profile →
Who can join
12 and older, any sex, with Solid Tumors Harboring MET Amplification. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants with Adverse Events (AE)s
Time frame: Up to 61.5 Months
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. -
Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)
Time frame: Up to 36 Months
OR is defined as (subjects achieving complete response \[CR\] or partial response \[PR\]) as assessed by ICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (criteria) (RANO) 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing.
Sponsor's own description
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of locally advanced or metastatic solid tumors that harbor MET amplification. This study will have 1 arm where participants will receive telisotuzumab adizutecan. Approximately 100 participants 12 years of age or older. with solid tumors harboring MET amplification will be enrolled in the study in up to 50 sites around the world. Participants will receive intravenous (IV) telisotuzumab adizutecan, as part of the 61.5 month study duration. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07196644
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Telisotuzumab Adizutecan
Trials testing the same drug.
- NCT05982873 — Expanded Access to Telisotuzumab Adizutecan · available
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07196644 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 28 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07196644.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing