ABBV-399 for Advanced Cancers

Recruiting at 45 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

237 Participants Needed

Trial Summary

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.

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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