← Back to Search

Antibody-Drug Conjugate

ABBV-399 for Advanced Cancers

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have advanced Non-Small Cell Lung Cancer (NSCLC) that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.

Participants in the combination therapy Arm E must have metastatic/locally advanced nonsquamous NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) del19 or L858R, with or without T790M mutation, and none of the EGFR mutations known to be resistant to osimertinib.

Must not have

Participant has history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.

Participant has received radiation therapy to the lung < 6 months prior to the first dose of ABBV-399.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, ABBV-399, to see if it is safe and effective in treating people with advanced solid tumors. The drug will be tested alone and in combination with other drugs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs which may mimic symptoms of autoimmune diseases. There could also be issues like fatigue and digestive disturbances due to the body's response to these powerful medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My advanced non-squamous NSCLC has specific EGFR mutations and no resistance to osimertinib.

Select...

My lung cancer is advanced, not mainly squamous, without certain mutations, and tests positive for c-Met.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had lung conditions treated with steroids.

Select...

I had lung radiation therapy less than 6 months ago.

Select...

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

Select...

I haven't had cancer treatment or taken herbal therapy shortly before starting ABBV-399.

Select...

I have side effects from cancer treatment that are still bothering me, except for hair loss or low blood count.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)

Maximum observed plasma concentration (Cmax)

Number of Participants with Adverse Events

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Monotherapy Telisotuzumab vedotin(28-day dosing cycles)Experimental Treatment1 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 Treatment1 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 CohortExperimental Treatment1 Intervention

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

Group IV: Arm E (Telisotuzumab vedotin plus Osimertinib)Experimental Treatment2 Interventions

Telisotuzumab vedotin to be evaluated with Osimertinib.

Group V: Arm D (Telisotuzumab vedotin plus Nivolumab)Experimental Treatment2 Interventions

Telisotuzumab vedotin to be evaluated with Nivolumab.

Group VI: Arm A (Telisotuzumab vedotin plus Erlotinib)Experimental Treatment2 Interventions

Telisotuzumab vedotin to be evaluated with Erlotinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug