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

Advanced Solid Tumors Cancer Clinical Trial

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumors Cancer
• Neoplasms

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