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

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

Sponsors

Lead sponsor: AbbVie

Source AbbVie
Brief 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.

Overall Status Completed
Start Date November 18, 2016
Completion Date October 29, 2019
Primary Completion Date July 30, 2019
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants with adverse events First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose
Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab 1 day of study drug administration within the 28-day cycle at the designated cohort dose
Area under the serum concentration-time curve (AUC) of ABBV-428 Up to 30 days after a 24-month treatment period
Terminal half-life (t1/2) of ABBV-428 Up to 30 days after a 24-month treatment period
Maximum observed serum concentration (Cmax) of ABBV-428 Up to 30 days after a 24-month treatment period
Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab Up to 2 years
Time to Cmax (Tmax) of ABBV-428 Up to 30 days after a 24-month treatment period
Secondary Outcome
Measure Time Frame
Duration of Objective Response (DOR) Up to 30 days after a 24-month of treatment period
Clinical benefit rate (CBR) Up to 30 days after a 24-month of treatment period
Progression-Free Survival (PFS) Up to 30 days after a 24-month of treatment period
Objective Response Rate (ORR) Up to 30 days after a 24-month of treatment period
Enrollment 61
Condition
Intervention

Intervention type: Drug

Intervention name: ABBV-428

Description: ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

Intervention type: Drug

Intervention name: Nivolumab

Description: Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.

Other name: OPDIVO

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Location
facility
HonorHealth Research Institute - Pima /ID# 155461 | Scottsdale, Arizona, 85258-2345, United States
UC Davis Comprehensive Cancer Center - Main /ID# 154439 | Sacramento, California, 95817, United States
University of Chicago /ID# 154440 | Chicago, Illinois, 60637-1443, United States
Fox Chase Cancer Center /ID# 170665 | Philadelphia, Pennsylvania, 19111, United States
Greenville Hospital System /ID# 154437 | Greenville, South Carolina, 29605, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 154441 | Houston, Texas, 77030-4000, United States
South Texas Accelerated Research Therapeutics /ID# 154442 | San Antonio, Texas, 78229, United States
Chris O'Brien Lifehouse /ID# 163131 | Camperdown, New South Wales, 2050, Australia
Northern Cancer Institute /ID# 163132 | St Leonards, New South Wales, 2065, Australia
Institut Bergonie /ID# 202391 | Bordeaux, Gironde, 33000, France
Institut Curie /ID# 162258 | Paris CEDEX 05, Ile-de-France, 75248, France
Gustave Roussy /ID# 162257 | Villejuif, Ile-de-France, 94805, France
Hopital de la Timone /ID# 162256 | Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, 13385, France
Centre Leon Berard /ID# 168072 | Lyon CEDEX 08, Rhone, 69373, France
National Cheng Kung University Hospital /ID# 169035 | Tainan City, Tainan, 70403, Taiwan
National Taiwan Univ Hosp /ID# 169034 | Taipei City, Taipei, 10002, Taiwan
Location Countries

Australia

France

Taiwan

United States

Verification Date

November 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Arm 1

Arm group type: Experimental

Description: ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).

Arm group label: Arm A, B, and C

Arm group type: Experimental

Description: Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.

Arm group label: Arm D

Arm group type: Experimental

Description: Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.

Arm group label: Arm 2

Arm group type: Experimental

Description: ABBV-428 plus nivolumab.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov