A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
AbbVie
Study ID
NCT03000257
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Tablet taken orally
  • Rovalpituzumab Tesirine — DRUG
    Intravenous infusion
  • ABBV-181 — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Dec 14, 2016
Status verified
Apr 2022
Primary completion
Mar 29, 2022
Completion
Mar 29, 2022

Study Design

Enrollment
182 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ABBV-181 plus Venetoclax
    Venetoclax will be taken once daily beginning 7 days prior to cycle 1 and continuing daily for a 28 day cycle and ABBV-181 will be administered every 4 weeks.
  • Experimental: ABBV-181
    ABBV-181 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Based on available safety, pharmacokinetic, and pharmacodynamic data from the dose-escalation part of the study, participants will be enrolled in dose-expansion cohorts to further evaluate ABBV-181 at a dose level which is at or below the Maximum tolerated dose (MTD). In the Monotherapy Expansion portion of the study, ABBV-181 will be administered in 28-day dosing cycles at either 1 dose per cycle or 2 doses per cycle. Based on available safety, PK and PD data from the single agent dose-escalation part of the study, a dose for ABBV-181 will be selected to evaluate in combination with Rovalpituzumab Tesirine or venetoclax.
  • Experimental: ABBV-181 plus Rovalpituzumab Tesirine
    Rovalpituzumab Tesirine will be given once every six weeks times two doses and ABBV-181 will be administered every 3 weeks.

Primary Outcome Measure

Part 1: Recommended Phase 2 Dose (RPTD) for Budigalimab [ Time Frame: Up to 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Moores Cancer Center at UC San Diego /ID# 157374La JollaCalifornia92093-
The University of Chicago Medical Center /ID# 157375ChicagoIllinois60637-1443-
Carolina BioOncology Institute /ID# 157376HuntersvilleNorth Carolina28078-
South Texas Accelerated Research Therapeutics /ID# 157378San AntonioTexas78229-
Virginia Cancer Specialists - Fairfax /ID# 157377FairfaxVirginia22031-

Find similar trials in La Jolla, CA

By research site
Moores Cancer Center at UC San Diego· La Jolla, CAThe University of Chicago Medical Center· Chicago, ILCarolina BioOncology Institute· Huntersville, NCSouth Texas Accelerated Research Therapeutics· San Antonio, TXVirginia Cancer Specialists - Fairfax· Fairfax, VA

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