A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors (NCT03000257) | Clinical Trial Compass
CompletedPhase 1
A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors
United States182 participantsStarted 2016-12-14
Plain-language 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 budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant must have an advanced solid tumor and must not be a candidate for surgical resection or other approved therapeutic regimen known to provide clinical benefit. For dose escalation, the participant may have been previously treated with a programmed cell death 1 (PD-I) targeting agent. For dose expansion, the participant must be PD-I/PD-L1 targeting agent naïve. For Part 2 budigalimab in combination with rovalpituzumab tesirine, the participant must have SCLC with progressive disease and have failed platinum containing therapy and be PD-1/PD-L1 targeting agent naïve. For Part 3 budigalimab in combination with venetoclax, the participant must have locally advanced or metastatic NSCLC and received 1 to 4 prior lines of therapy in the advanced or metastatic setting including 1 regimen that included a PD-1 or PD-L1 targeting agent which was discontinued following disease progression. Participants who are naïve to treatment with a PD-1/PD-L1 targeting agent OR who have received more than 1 regimen containing a PD-1/PD-L1 targeting agent are NOT eligible for Part 3.
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for the monotherapy cohort and an ECOG 0 to 1 for budigalimab in combination with rovalpituzumab tesirine cohort (Part 2) and budigalimab in combination with venetoclax (Part 3).
* Participants have adequate bone marrow, renal, hepatic and coagulation function.
* Participants must have measurable or…
What they're measuring
1
Part 1: Recommended Phase 2 Dose (RPTD) for Budigalimab
Timeframe: Up to 6 months
2
Part 1: Maximum tolerated dose (MTD) of Budigalimab
Timeframe: Up to 6 months
3
Part 1 and Part 3: Terminal Half-life (t1/2) of Budigalimab
Timeframe: Up to 4 Weeks
4
Part 1 and Part 3: Maximum Observed Serum Concentration (Cmax) of Budigalimab
Timeframe: Up to 12 Weeks
5
Part 1 and Part 3: Time to Cmax (Tmax) of Budigalimab
Timeframe: Up to 12 Weeks
6
Part 1 and Part 3: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Budigalimab
Timeframe: Up to 12 Weeks
7
Part 2: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Rovalpituzumab Tesirine Combination
Timeframe: Up to 6 Months
8
Part 3: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Venetoclax Combination.