A Phase 1 interventional study of ABBV-428 and Nivolumab in Advanced Solid Tumors Cancer, sponsored by AbbVie. Completed at 15 sites in 4 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-07-20.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 61 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
Drug: ABBV-428
Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.
Drug: ABBV-428
Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
Drug: ABBV-428 · Drug: Nivolumab
ABBV-428 plus nivolumab.
Drug: ABBV-428 · Drug: Nivolumab
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Also known as: OPDIVO
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
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.
Time frame: 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
Time frame: Up to 30 days after a 24-month treatment period
Terminal half-life (t1/2) of ABBV-428
Time frame: Up to 30 days after a 24-month treatment period
Maximum observed serum concentration (Cmax) of ABBV-428
Time frame: 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
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.
Time frame: Up to 2 years
Time to Cmax (Tmax) of ABBV-428
Time frame: Up to 30 days after a 24-month treatment period
Duration of Objective Response (DOR)
DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Time frame: Up to 30 days after a 24-month of treatment period
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.
Time frame: Up to 30 days after a 24-month of treatment period
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
Time frame: Up to 30 days after a 24-month of treatment period
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
Time frame: Up to 30 days after a 24-month of treatment period
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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