Telisotuzumab Vedotin for Lung Cancer

Recruiting at 26 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: c-Met antibodies, Docetaxel

Disqualifiers: EGFR mutations, CNS metastases, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 70 to 80 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

What data supports the effectiveness of the drug Telisotuzumab Vedotin for lung cancer?

Research shows that Telisotuzumab Vedotin has demonstrated antitumor activity in patients with non-small cell lung cancer, with some patients achieving partial responses and stable disease. In a study with Japanese patients, the drug showed a disease control rate of 89% and a median progression-free survival of 7.1 months. ^{1 2 3 4 5}

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

Telisotuzumab Vedotin is unique because it is an antibody-drug conjugate that specifically targets c-Met, a protein often overexpressed in certain lung cancers, allowing it to deliver chemotherapy directly to cancer cells. This targeted approach may offer benefits over traditional chemotherapy by potentially reducing damage to healthy cells. ^{1 2 3 4 5}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults with non-squamous Non-Small Cell Lung Cancer (NSCLC) that's advanced or spread, who've had no more than one prior chemo treatment and have progressed after therapy. They should be relatively active (able to care for themselves), know their EGFR mutation status, and expect to live at least 12 weeks.

Inclusion Criteria

My doctor expects me to live at least 12 more weeks.

My cancer has been tested for EGFR mutations.

My lung cancer is advanced but not of the squamous type.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) infusion of telisotuzumab vedotin at 1 of 2 doses as part of a 3 year study duration

3 years

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Telisotuzumab Vedotin

Trial Overview The trial is testing Telisotuzumab Vedotin, an experimental drug for NSCLC. Participants are randomly assigned to receive one of two doses via IV infusion in a study lasting up to three years across various global locations.

Participant Groups

Group I: Telisotuzumab Vedotin Dose C Experimental Treatment 1 Intervention

Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.

Group II: Telisotuzumab Vedotin Dose B Experimental Treatment 1 Intervention

Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.

Group III: Telisotuzumab Vedotin Dose A Experimental Treatment 1 Intervention

Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.

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 (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 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, 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]

Telisotuzumab vedotin, an antibody-drug conjugate targeting c-MET, showed a low response rate of only 9% in patients with c-MET-positive squamous cell carcinoma, leading to the early closure of the study due to lack of efficacy.

The treatment was associated with significant toxicities, including three grade 5 adverse events, notably pneumonitis, highlighting safety concerns in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753). Waqar, SN., Redman, MW., Arnold, SM., et al.[2022]

References

1. 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]

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

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

A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753). [2022]