Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
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-181. This study will also evaluate the safety and tolerability of ABBV-181 in combination with Rovalpituzumab Tesirine. The study will consist of 2 parts: ABBV-181 monotherapy dose escalation and expansion, and ABBV-181 in combination with Rovalpituzumab Tesirine.

Official Title

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181, a Monoclonal Antibody, as Monotherapy and in Combination With Another Anti-Cancer Therapy in Subjects With Advanced Solid Tumors

Keywords

Advanced Solid Tumors Cancer Non-small cell lung cancer (NSCLC) Triple negative breast cancer Ovarian cancer Hepatocellular carcinoma Gastric cancer Small cell lung cancer Mesothelioma Cholangiocarcinoma Merkel cell carcinoma Head and neck cancer Rovalpituzumab Tesirine ABBV-181 ABBV-181 plus Rovalpituzumab Tesirine

Eligibility

You can join if…

Open to people ages 18-99

  • Participant must have an advanced solid tumor and must not be a candidate for surgical resection or other approved therapeutic regimen known to provide clinical benefit. For dose escalation, the participant may have been previously treated with a programmed cell death 1 (PD-I) targeting agent. For dose expansion, the participant must be PD-I/PD-L1 targeting agent naïve. For Combination, the participant must be have SCLC with progressive disease and have failed platinum containing therapy and be PD-1/PD-L1 targeting agent naïve.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for Monotherapy and 0 to 1 for Combination.
  • Participants have adequate bone marrow, renal, hepatic and coagulation function.
  • Participants must have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the dose escalation portion of the trial. Participants in the expansion cohort must have measurable disease per RECIST version 1.1 or disease evaluable by assessment of tumor antigens.

You CAN'T join if...

  • Participant has received anticancer therapy including chemotherapy, immunotherapy,radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives, prior to the first dose of ABBV-181 or Rovalpituzumab Tesirine.
  • For Combination therapy, participant must not have had prior exposure to Rovalpituzumab Tesirine or a pyrrolobenzodiazepine (PBD) based drug.
  • Participant has unresolved adverse events greater than grade 1 from prior anticancer therapy except for alopecia.
  • 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. Subjects who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA are anti-viral therapy may be enrolled.
  • Participant has known history or inflammatory bowel disease, pneumonitis, or known uncontrolled metastases to the central nervous system (CNS) (with certain exceptions).
  • In Japan, participants with a history of or ongoing interstitial lung disease are also excluded.

Locations

  • Ucsd /Id# 157374 not yet accepting patients
    La Jolla California 92037 United States
  • South Texas Accelerated Research Therapeutics /ID# 157378 accepting new patients
    San Antonio Texas 78229 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03000257
Phase
Phase 1
Study Type
Interventional
Last Updated