Summary

for people ages 18-99 (full criteria)
at UC Davis
study started
estimated completion

Description

Summary

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.

Official Title

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

Keywords

Advanced Solid Tumors Cancer Cancer Neoplasm Advanced solid tumor Nivolumab Non-small cell lung cancer (NSCLC) Non-squamous NSCLC Ovarian cancer ABBV-428

Eligibility

You can join if…

Open to people ages 18-99

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC Davis Comp Cancer Ctr /ID# 154439 accepting new patients
    Sacramento California 95817 United States
  • HonorHealth Research Institute - Pima /ID# 155461 accepting new patients
    Scottsdale Arizona 85258-2345 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02955251
Phase
Phase 1
Study Type
Interventional
Last Updated