237 Participants Needed

ABBV-399 for Advanced Cancers

Recruiting at 45 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AbbVie
Must be taking: Osimertinib, Erlotinib, Nivolumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

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.

Who Is on the Research Team?

AI

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.
See 6 more

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.
See 13 more

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?
6Treatment groups
Experimental Treatment
Group I: Monotherapy Telisotuzumab vedotin(28-day dosing cycles)Experimental Treatment1 Intervention
Group II: Monotherapy Telisotuzumab vedotin (21-day dosing cycles)Experimental Treatment1 Intervention
Group III: Monotherapy Expansion CohortExperimental Treatment1 Intervention
Group IV: Arm E (Telisotuzumab vedotin plus Osimertinib)Experimental Treatment2 Interventions
Group V: Arm D (Telisotuzumab vedotin plus Nivolumab)Experimental Treatment2 Interventions
Group VI: Arm A (Telisotuzumab vedotin plus Erlotinib)Experimental Treatment2 Interventions

Find a Clinic Near You

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

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