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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02955251
Other study ID # M15-819
Secondary ID 2016-001461-88
Status Completed
Phase Phase 1
First received
Last updated
Start date November 18, 2016
Est. completion date October 29, 2019

Study information

Verified date July 2020
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 29, 2019
Est. primary completion date October 29, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Nivolumab
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.

Locations

Country Name City State
Australia Chris O'Brien Lifehouse /ID# 163131 Camperdown New South Wales
Australia Northern Cancer Institute /ID# 163132 St Leonards New South Wales
France Institut Bergonie /ID# 202391 Bordeaux Gironde
France Centre Leon Berard /ID# 168072 Lyon CEDEX 08 Rhone
France Hopital de la Timone /ID# 162256 Marseille CEDEX 05 Provence-Alpes-Cote-d Azur
France Institut Curie /ID# 162258 Paris CEDEX 05 Ile-de-France
France Gustave Roussy /ID# 162257 Villejuif Ile-de-France
Taiwan National Taiwan Univ Hosp /ID# 169034 Taipei City Taipei
United States University of Chicago /ID# 154440 Chicago Illinois
United States Greenville Hospital System /ID# 154437 Greenville South Carolina
United States MD Anderson Cancer Center at Texas Medical Center /ID# 154441 Houston Texas
United States Fox Chase Cancer Center /ID# 170665 Philadelphia Pennsylvania
United States UC Davis Comprehensive Cancer Center - Main /ID# 154439 Sacramento California
United States South Texas Accelerated Research Therapeutics /ID# 154442 San Antonio Texas
United States HonorHealth Research Institute - Pima /ID# 155461 Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  France,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data. 1 day of study drug administration within the 28-day cycle at the designated cohort dose
Primary Area under the serum concentration-time curve (AUC) of ABBV-428 Up to 30 days after a 24-month treatment period
Primary Terminal half-life (t1/2) of ABBV-428 Up to 30 days after a 24-month treatment period
Primary Maximum observed serum concentration (Cmax) of ABBV-428 Up to 30 days after a 24-month treatment period
Primary Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity. Up to 2 years
Primary Time to Cmax (Tmax) of ABBV-428 Up to 30 days after a 24-month treatment period
Secondary Duration of Objective Response (DOR) DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first. Up to 30 days after a 24-month of treatment period
Secondary Clinical benefit rate (CBR) CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment. Up to 30 days after a 24-month of treatment period
Secondary Progression-Free Survival (PFS) PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first Up to 30 days after a 24-month of treatment period
Secondary Objective Response Rate (ORR) ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment. Up to 30 days after a 24-month of treatment period
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