Telisotuzumab Vedotin for Lung Cancer

Recruiting at 299 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Live vaccines, Systemic steroids

Disqualifiers: Radiation therapy, Adenosquamous histology, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 42

270 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests telisotuzumab vedotin, a treatment that targets and kills cancer cells, in NSCLC patients with high c-Met levels. It aims to find the best patient group for this therapy and evaluate its safety and effectiveness. Telisotuzumab vedotin is a specialized treatment targeting c-Met-overexpressing tumor cells, and it has been evaluated in various studies for its safety and efficacy in treating advanced solid tumors, including non-small cell lung cancer.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that treatment with certain therapies within specific time intervals before the first dose of the study drug is excluded, so it's best to discuss your current medications with the trial team.

Is Telisotuzumab Vedotin safe for humans?

Telisotuzumab Vedotin has been studied in humans and generally shows a manageable safety profile. Common side effects include numbness or tingling in the hands and feet, nausea, reduced appetite, and lower white blood cell counts. Serious side effects like a significant drop in certain blood cells and low protein levels in the blood were less common. ^{1 2 3 4 5}

What makes the drug Telisotuzumab Vedotin unique for lung cancer treatment?

Telisotuzumab Vedotin is unique because it combines an antibody that targets cancer cells with a chemotherapy drug, allowing it to deliver the drug directly to the cancer cells, potentially reducing side effects compared to traditional chemotherapy that affects the whole body. ^{6 7 8 9 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with non-squamous Non-Small Cell Lung Cancer (NSCLC) that does not have a certain mutation called EGFR. Participants must have c-Met+ NSCLC, confirmed by specific lab tests, and should have tried no more than two previous systemic therapies. They need to be in good physical condition (ECOG 0-1), and cannot join if they've had other cancers recently, untreated hepatitis B or C, HIV infection, lung diseases like ILD/pneumonitis, or major surgery within the last three weeks.

Inclusion Criteria

Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.

My condition is advanced or metastatic non-small cell lung cancer.

My lung cancer is c-Met positive as confirmed by a specific lab test.

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I had lung radiation therapy less than 6 months ago.

I have had cancer before, but it's not one of the types excluded in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Stage 1

Identify target NSCLC population(s) that overexpress c-Met best suited for telisotuzumab vedotin therapy in the second or third line setting

Up to approximately 3 years

IV infusion every 14 days

Treatment - Stage 2

Expand the group(s) to further evaluate efficacy in the selected population(s)

Up to approximately 3 years

IV infusion every 14 days

Treatment - Stage 3

Evaluate the safety and efficacy of telisotuzumab vedotin at an alternate dose level

Up to approximately 3 years

IV infusion every 14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Telisotuzumab Vedotin

Trial Overview The study is testing Telisotuzumab vedotin on patients who overexpress c-Met and are in their second or third line of cancer treatment. It's done in stages: first to find which NSCLC populations benefit most from the drug (Stage 1 completed), then expanding this group to further test effectiveness (Stage 2), followed by an additional cohort at a different dose level for safety and efficacy evaluation (Stage 3).

Participant Groups

Group I: Telisotuzumab vedotin Experimental Treatment 1 Intervention

Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Telisotuzumab vedotin is effective in treating MET-overexpressing non-squamous non-small cell lung cancer, but some patients develop resistance to it.

In a case study of a 56-year-old woman with KIF5B-MET fusion-positive lung cancer, capmatinib was able to provide a durable response after she developed resistance to telisotuzumab vedotin, suggesting it as a potential subsequent therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Salvage capmatinib therapy in KIF5B-MET fusion-positive lung adenocarcinoma with resistance to telisotuzumab vedotin. Lin, CY., Wei, SH., Chen, YL., et al.[2022]

In a phase 1b study involving 37 patients with advanced non-small cell lung cancer (NSCLC), the combination of Telisotuzumab vedotin (Teliso-V) and nivolumab was found to be well tolerated, with common side effects including fatigue (27%) and peripheral sensory neuropathy (19%).

The combination therapy showed limited antitumor activity, with an objective response rate of only 7.4% and a median progression-free survival of 7.2 months for PD-L1-positive patients, indicating that while the treatment is safe, its effectiveness may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC. Camidge, DR., Barlesi, F., Goldman, JW., et al.[2022]

Telisotuzumab vedotin (Teliso-V) demonstrated safety and tolerability in patients with non-small cell lung cancer (NSCLC), with no dose-limiting toxicities observed at doses up to 2.2 mg/kg every two weeks and 2.7 mg/kg every three weeks.

In terms of efficacy, 23% of patients with c-Met positive NSCLC showed objective responses to Teliso-V, with a median duration of response of 8.7 months and a median progression-free survival of 5.2 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. Camidge, DR., Morgensztern, D., Heist, RS., et al.[2023]

Telisotuzumab vedotin, an antibody-drug conjugate targeting c-Met-overexpressing tumors, showed a manageable safety profile in a phase 1 study with Japanese patients, with no dose-limiting toxicities observed at doses of 2.4 mg/kg and 2.7 mg/kg.

The treatment demonstrated preliminary antitumor activity, with an overall disease control rate of 89% and a median progression-free survival of 7.1 months, confirming the recommended phase 2 dose as 2.7 mg/kg every 3 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors. Fujiwara, Y., Kenmotsu, H., Yamamoto, N., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Case report: Salvage capmatinib therapy in KIF5B-MET fusion-positive lung adenocarcinoma with resistance to telisotuzumab vedotin. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A phase II study of ABT-751 in patients with advanced non-small cell lung cancer. [2015]

7. Ireland pubmed.ncbi.nlm.nih.gov

Second-line treatment with vinorelbine and carboplatin in patients with advanced non-small cell lung cancer. A multicenter phase II study. [2019]

8. Greece pubmed.ncbi.nlm.nih.gov

Phase I trial of carboplatin and etoposide in combination with panobinostat in patients with lung cancer. [2021]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Lipid Based Aqueous Core Nanocapsules (ACNs) for Encapsulating Hydrophillic Vinorelbine Bitartrate: Preparation, Optimization, Characterization and In vitro Safety Assessment for Intravenous Administration. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Randomized study of vinorelbine (VRB) versus vindesine (VDS) in previously untreated stage IIIB or IV non-small-cell lung cancer (NSCLC). The Japan Vinorelbine Lung Cancer Cooperative Study Group. [2020]