ABBV-399 for Advanced Cancers

Not currently recruiting at 53 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must be taking: Osimertinib, Erlotinib, Nivolumab

Must not be taking: Anticonvulsants, Corticosteroids

Disqualifiers: Radiation, CNS metastases, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABBV-399 (an experimental drug) for individuals with advanced cancers, specifically non-small cell lung cancer (NSCLC). The main goal is to assess the safety and effectiveness of ABBV-399, both alone and in combination with other cancer treatments like osimertinib, erlotinib, and nivolumab. Individuals with advanced NSCLC that cannot be treated with surgery or other approved therapies, and who experience frequent health issues due to their cancer, might be suitable candidates for the trial. The trial aims to determine if ABBV-399 can slow or stop cancer growth. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticancer therapy, including chemotherapy, immunotherapy, biologic, or investigational therapy, within 21 days before starting ABBV-399. Herbal therapy must be stopped 7 days prior. If you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them 14 days before the study drug administration, unless they are inhaled, locally injected, or topical steroids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that telisotuzumab vedotin, the treatment being tested, is generally well-tolerated. Research indicates that when taken alone, it is safe, with manageable side effects.

When combined with other drugs like erlotinib or osimertinib, it remains safe. Research suggests these combinations are well-tolerated, with side effects similar to those expected in cancer treatments.

In combination with nivolumab, studies also show that the treatment is well-tolerated. Side effects occur but are generally not severe.

Overall, while side effects exist, the treatment has proven safe enough for continued testing in clinical trials. Participants in past studies have mostly managed the side effects without serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Telisotuzumab vedotin is unique because it targets c-Met, a protein often overexpressed in various cancers, which makes it stand out from existing therapies that do not specifically target this protein. Researchers are excited about combining it with other agents like Nivolumab, Erlotinib, and Osimertinib, as these combinations may enhance its effectiveness and potentially improve outcomes for patients with advanced cancers. By leveraging targeted therapy and novel combinations, these treatments aim to offer more personalized and potentially more effective options compared to the current standards of care.

What evidence suggests that this trial's treatments could be effective for advanced cancers?

Research has shown that telisotuzumab vedotin may help treat non-small cell lung cancer (NSCLC) with high levels of the protein c-Met. Studies have found that up to 35% of patients with elevated c-Met levels responded to this treatment. In this trial, researchers are evaluating telisotuzumab vedotin in different treatment arms. One arm combines telisotuzumab vedotin with erlotinib, showing promising results in patients who previously received EGFR-targeted therapy. Another arm evaluates telisotuzumab vedotin with nivolumab, which has produced lasting responses in some lung cancer cases. Additionally, telisotuzumab vedotin is being tested with osimertinib in patients with certain genetic changes and high c-Met levels. These findings suggest that telisotuzumab vedotin, either alone or with other drugs, could be effective for some advanced cancers. ^{2 3 6 7 8}

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 advanced solid tumors likely to express c-Met. They should have an ECOG Performance Status of 0-2, adequate organ function, and no more than two prior systemic therapies. Women must test negative for pregnancy. Participants can't join if they've had recent anticancer treatments, lung disease requiring steroids, unresolved side effects from previous cancer therapy (except hair loss or anemia), major surgery within the last three weeks, certain immunological conditions or medications.

Inclusion Criteria

My advanced lung cancer cannot be treated with surgery or other effective therapies.

Participant must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

Participant has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue confirmed available for analyses.

Exclusion Criteria

Participant has a clinically significant condition(s) described in the protocol.

I had lung radiation therapy less than 6 months ago.

My cancer has spread to my brain and is not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Telisotuzumab vedotin as monotherapy or in combination with other drugs in 21-day or 28-day dosing cycles

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-399
• Erlotinib
• Nivolumab
• Osimertinib

Trial Overview The study is testing ABBV-399 alone and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors that express a specific protein called c-Met. The monotherapy arms are closed; now it's about how ABBV-399 works when combined with other drugs.

How Is the Trial Designed?

Group I: Monotherapy Telisotuzumab vedotin(28-day dosing cycles) Experimental Treatment 1 Intervention

Telisotuzumab vedotin will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.

Group II: Monotherapy Telisotuzumab vedotin (21-day dosing cycles) Experimental Treatment 1 Intervention

Telisotuzumab vedotin will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.

Group III: Monotherapy Expansion Cohort Experimental Treatment 1 Intervention

Telisotuzumab vedotin will be administered every 14 days on a 28-day dosing cycle.

Group IV: Arm E (Telisotuzumab vedotin plus Osimertinib) Experimental Treatment 2 Interventions

Telisotuzumab vedotin to be evaluated with Osimertinib.

Group V: Arm D (Telisotuzumab vedotin plus Nivolumab) Experimental Treatment 2 Interventions

Telisotuzumab vedotin to be evaluated with Nivolumab.

Group VI: Arm A (Telisotuzumab vedotin plus Erlotinib) Experimental Treatment 2 Interventions

Telisotuzumab vedotin to be evaluated with Erlotinib.

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

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8618

LUMINOSITY, a phase 2 study of telisotuzumab vedotin in ... 1. Results: As of 21 Feb 2024, 172 pts received ≥1 dose of Teliso-V and 168 pts were included in efficacy analyses (c-Met ...

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

Phase I Study of 2- or 3-Week Dosing of Telisotuzumab ... Here, we present safety and efficacy data from a phase I/Ib study of Teliso-V monotherapy evaluated in once every 2 weeks/once every 3 weeks schedules in ...

4. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression

FDA grants accelerated approval to telisotuzumab vedotin ... The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR), determined by blinded independent ...

5. onclive.com onclive.com/view/telisotuzumab-vedotin-maintains-efficacy-across-key-subgroups-in-pretreated-nsclc-with-c-met-overexpression

Telisotuzumab Vedotin Maintains Efficacy Across Key ... With telisotuzumab vedotin, we're seeing response rates as high as 35% in patients that are c-MET 3+ by IHC and in the middle of the 20% range ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02099058

NCT02099058 | A Study Evaluating the Safety, ... This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination ...

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

Phase Ib Study of Telisotuzumab Vedotin in Combination ... Teliso-V plus erlotinib showed encouraging antitumor activity and an acceptable safety profile in EGFR TKI-pretreated patients with EGFR ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)62282-9/fulltext

Preliminary Results of Safety and PK of Telisotuzumab ... Preliminary safety, PK and efficacy in Japanese pts with solid tumors suggest T was tolerated and showed encouraging anti-cancer effects, warranting continued ...