Telisotuzumab Vedotin for Lung Cancer

Not currently recruiting at 432 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called telisotuzumab vedotin, an experimental drug, for individuals with non-small cell lung cancer (NSCLC) that is locally advanced or has metastasized. Researchers aim to determine if this treatment is effective for patients whose cancer overproduces a protein called c-Met. The trial seeks to assess the treatment's effectiveness and ensure its safety for future use. Individuals who have undergone up to two prior cancer treatments and have specific types of NSCLC without certain gene changes may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that telisotuzumab vedotin is likely to be safe for humans?

Research has shown that telisotuzumab vedotin maintains a consistent safety record. In past studies, participants generally tolerated the treatment well, and no new safety issues emerged. The common side effects resembled those of other lung cancer treatments, such as tiredness, nausea, and low blood cell counts.

Earlier research indicated that patients managed telisotuzumab vedotin well when administered every two or three weeks. Even when combined with another drug, erlotinib, the side effects remained manageable.

Overall, evidence suggests that telisotuzumab vedotin is safe for those considering participation in a clinical trial. However, discussing potential risks and benefits with a healthcare provider remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Telisotuzumab vedotin is unique because it targets a specific protein called c-Met, which is often overexpressed in certain lung cancers. This targeted approach is different from traditional chemotherapy, which attacks rapidly dividing cells more broadly, often leading to significant side effects. Additionally, telisotuzumab vedotin is delivered via intravenous infusion every 14 days, which might offer a convenient dosing schedule compared to some existing treatments. Researchers are excited about its potential for a more precise attack on cancer cells, possibly leading to better outcomes with fewer side effects.

What evidence suggests that telisotuzumab vedotin might be an effective treatment for lung cancer?

Research has shown that telisotuzumab vedotin, which participants in this trial will receive, may help treat non-small cell lung cancer (NSCLC) with high levels of a protein called c-Met. In one study, about 31% of patients who received this drug experienced tumor shrinkage. Additionally, 86% of patients had their disease controlled, meaning their cancer either shrank or stopped growing. These findings suggest that telisotuzumab vedotin could be effective for patients whose lung cancer has worsened after other treatments. This experimental drug targets cancer cells with excess c-Met, potentially making it a good option for some patients. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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 (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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03539536

NCT03539536 | Study of Telisotuzumab Vedotin (ABBV- ... This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9401525/

Phase I Study of 2- or 3-Week Dosing of Telisotuzumab ... With regard to activity, Teliso-V monotherapy at doses ≥2.4 mg/kg once every 3 weeks showed promising efficacy in patients with c-Met–overexpressing NSCLC, with ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00739

Phase Ib Study of Telisotuzumab Vedotin in Combination ... Despite these demographics, the ORR and DCR were 30.6% and 86.1%, respectively, in the overall efficacy set, demonstrating an improvement over ...

4. news.abbvie.com news.abbvie.com/2023-11-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-2-LUMINOSITY-Trial-Evaluating-Telisotuzumab-Vedotin-Teliso-V-for-Patients-with-Previously-Treated-Non-Small-Cell-Lung-Cancer-NSCLC

AbbVie Announces Positive Topline Results from Phase 2 ... LUMINOSITY trial demonstrated compelling clinical benefits across key endpoints; Teliso-V is an investigational first-in-class, ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT263039

Results of the phase 1b study of ABBV-399 (telisotuzumab ... Results of the phase 1b study of ABBV-399 (telisotuzumab vedotin; teliso-v) in combination with erlotinib in patients with c-Met+ non-small cell lung cancer by ...