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Brief Title: Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: M19-345
  • Secondary ID: 2018-004303-40
  • NTC ID: NCT03821935
  • Sponsor: AbbVie

BRIEF SUMMARY


The study will determine the recommended Phase 2 dose (RP2D) of ABBV-151 administered as
monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety,
pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with
budigalimab. The study will consist of 2 phases: dose escalation and dose expansion.


  • Overall Status
    Recruiting
  • Start Date
    February 21, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose Escalation: Recommended Phase 2 Dose (RP2D) ABBV-151 Monotherapy

Primary Outcome 1 - Timeframe: Up to 28 days after the first dose of ABBV-151 monotherapy

Primary Outcome 2 - Measure: Dose Escalation: RP2D ABBV-151 + Budigalimab Combination Therapy

Primary Outcome 2 - Timeframe: Up to 28 days after the first dose of ABBV-151 and ABBV-181 combination therapy

Primary Outcome 3 - Measure: Dose Expansion: Objective Response Rate (ORR)

Primary Outcome 3 - Timeframe: Up to approximately 6 months after the first dose date of last participant in Dose Expansion

CONDITION

  • Advanced Solid Tumors Cancer

ELIGIBILITY


Inclusion Criteria:

- For Dose Escalation only: Participants with an advanced solid tumor who are considered
refractory to or intolerant of all existing therapy(ies) known to provide a clinical
benefit for their condition. Additionally, participants who have been offered standard
therapies and refused, or who are considered ineligible for standard therapies, may be
eligible for this study on a case-by-case basis, after discussion with and agreement
from the sponsor. Participants with triple-negative breast cancer (TNBC), pancreatic
adenocarcinoma, urothelial cancer, Hepatocellular carcinoma (HCC), or Head and neck
squamous cell carcinoma (HNSCC) who are being considered for the dose escalation
cohorts must also meet the histology specific eligibility criteria described below for
dose expansion

- For Dose Expansion only participants must meet criteria specific to the type of
cancer:

- TNBC - Female or male participants with confirmed breast adenocarcinoma that is
ER-negative, PR-negative, and HER2-negative, (as defined per American Society of
Clinical Oncology [ASCO]/College of American Pathology [CAP] guidelines), who must
have disease progression during or after at least 1 systemic therapy that included a
taxane in the metastatic or recurrent setting.

- Pancreatic adenocarcinoma and have disease progression during or after 1 systemic
therapy (gemcitabine monotherapy or in combination with other agents, FOLFIRINOX [or
another regimen including both 5-fluorouracil and oxaliplatin], capecitabine
monotherapy or in combination with other agents) administered in the adjuvant, locally
advanced, or metastatic setting. If the therapy was used in an adjuvant setting,
disease progression must have occurred within 6 months of completing adjuvant therapy.

- Urothelial cancer of the bladder and urinary tract and must have progressed following
treatment with a platinum-based regimen (administered in any line of therapy) and a
programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administered in the
recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is
defined as unequivocal progression on or within 3 months of the last dose of anti-PD1
or anti-PDL1 therapy).

- HCC and must have disease progression during or after 1 prior line of systemic
therapy.

- HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have
progressed following treatment with platinum-based regimen (administered in any line
of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic
setting (progression following a PD1/PDL1 antagonist is defined as unequivocal
progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).

- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
to 1.

- Participant has adequate bone marrow, renal, hepatic, and coagulation function. Must
have a viral status consistent with the requirements described in the protocol
specific to type of cancer and stage of study (Dose Escalation or Dose Expansion).

Exclusion Criteria:

- For Dose Expansion only: Participants (except for participants with urothelial cancer
or HNSCC) who have had prior exposure to immunotherapies as listed in the protocol.

- Has received anticancer therapy including chemotherapy, immunotherapy, radiation
therapy, biologic, herbal therapy, or any investigational therapy within a period of 5
half-lives or 28 days (whichever is shorter), prior to the first dose of the study
drug.

- Participant has unresolved AEs > Grade 1 from prior anticancer therapy except for
alopecia.

- Has a history of primary immunodeficiency, bone marrow transplantation, solid organ
transplantation, or previous clinical diagnosis of tuberculosis.

- Has a known uncontrolled metastases to the central nervous system (with certain
exceptions).

- Current or prior use of immunosuppressive medication within 14 days prior to the first
dose of the study drug.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: ABBVIE INC.

Role: Study Director

Affiliation: AbbVie

Overall Contact

Name: ABBVIE INC.

Phone: 844-663-3742

Email: abbvieclinicaltrials@abbvie.com

LOCATION

Facility Status Contact
Facility: Yale University /ID# 208356
New Haven, Connecticut 06510
United States
Status: Recruiting Contact: N/A
Facility: AdventHealth Celebration /ID# 224860
Kissimmee, Florida 34747-4970
United States
Status: Recruiting Contact: N/A
Facility: AdventHealth Cancer Institute - Orlando /ID# 226953
Orlando, Florida 32804
United States
Status: Recruiting Contact: N/A
Facility: Indiana Univ School Medicine /ID# 208384
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: N/A
Facility: Univ Michigan Med Ctr /ID# 221129
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: N/A
Facility: NYU Langone Medical Center /ID# 209822
New York, New York 10016-6402
United States
Status: Recruiting Contact: N/A
Facility: Carolina BioOncology Institute /ID# 208358
Huntersville, North Carolina 28078
United States
Status: Recruiting Contact: N/A
Facility: The Ohio State University - The James /ID# 217611
Columbus, Ohio 43210-1240
United States
Status: Recruiting Contact: N/A
Facility: NEXT Oncology /ID# 208930
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: Chris O'Brien Lifehouse /ID# 213236
Camperdown, New South Wales 2050
Australia
Status: Recruiting Contact: N/A
Facility: UCL Saint-Luc /ID# 218466
Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
Belgium
Status: Recruiting Contact: N/A
Facility: Princess Margaret Cancer Centre /ID# 209423
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact: N/A
Facility: Hopital Universitaire Purpan /ID# 218667
Toulouse, Haute-Garonne 31059
France
Status: Recruiting Contact: N/A
Facility: Centre Leon Berard /ID# 218515
Lyon CEDEX 08, Rhone 69373
France
Status: Recruiting Contact: N/A
Facility: Centre Jean Perrin /ID# 218669
Clermont Ferrand, 63011
France
Status: Recruiting Contact: N/A
Facility: Sheba Medical Center /ID# 209037
Ramat Gan, 5239424
Israel
Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital East /ID# 224808
Kashiwa-shi, Chiba 277-8577
Japan
Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital /ID# 209421
Chuo-ku, Tokyo 104-0045
Japan
Status: Recruiting Contact: N/A
Facility: Yonsei University Health System Severance Hospital /ID# 218512
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital /ID# 218513
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Pan American Center for Oncology Trials, LLC /ID# 217475
Rio Piedras, 00935
Puerto Rico
Status: Recruiting Contact: N/A
Facility: Hospital Clinic de Barcelona /ID# 221106
Barcelona, 08036
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 220928
Madrid, 28040
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clinico Universitario de Valencia /ID# 221107
Valencia, 46010
Spain
Status: Recruiting Contact: N/A
Facility: China Medical University Hosp /ID# 218492
Taichung City, Taichung 40447
Taiwan
Status: Recruiting Contact: N/A
Facility: National Taiwan University Hospital /ID# 218490
Taipei City, Taipei 100
Taiwan
Status: Recruiting Contact: N/A