Description:
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.
Title
- Brief Title: A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
- 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 IDs
- ORG STUDY ID:
M15-819
- SECONDARY ID:
2016-001461-88
- NCT ID:
NCT02955251
Conditions
- Advanced Solid Tumors Cancer
Interventions
Drug | Synonyms | Arms |
---|
ABBV-428 | | Arm 1 |
Nivolumab | OPDIVO | Arm 2 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 | Experimental | ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). | |
Arm A, B, and C | Experimental | Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428. | |
Arm D | Experimental | Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab. | |
Arm 2 | Experimental | ABBV-428 plus nivolumab. | |
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.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with adverse events |
Time Frame: | First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Duration of Objective Response (DOR) |
Time Frame: | Up to 30 days after a 24-month of treatment period |
Safety Issue: | |
Description: | DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first. |
Measure: | Clinical benefit rate (CBR) |
Time Frame: | Up to 30 days after a 24-month of treatment period |
Safety Issue: | |
Description: | 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. |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Up to 30 days after a 24-month of treatment period |
Safety Issue: | |
Description: | PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first |
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to 30 days after a 24-month of treatment period |
Safety Issue: | |
Description: | ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | AbbVie |
Trial Keywords
- Cancer
- Neoplasm
- Advanced solid tumor
- Nivolumab
- Non-small cell lung cancer (NSCLC)
- Non-squamous NSCLC
- Ovarian cancer
Last Updated
July 20, 2020