A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

  • Interventional
  • Not Recruiting
  • NCT02955251
Eligibility Details Visit Clinicaltrials.gov

A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

Gender
All

Age Group
18 Years to 99 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.

         - Participants have adequate bone marrow, renal, hepatic and coagulation function.

         - For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

         - Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.

        Exclusion Criteria:

         - Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.

         - Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).

         - History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.

         - Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.

         - Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.

         - Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
  • Solid Tumors
  • Cancer

At a Glance

National Government IDNCT02955251

IRB#IRB16-1324

Lead SponsorAbbVie

Lead PhysicianHedy Kindler

Collaborator(s)N/A

EligibilityAll
18 Years to 99 Years
Not Recruiting