Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
AbbVie
Study ID
NCT03821935
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumors Cancer

Eligibility Criteria

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

Interventions

  • Livmoniplimab — DRUG
    Liquid for intravenous infusion.
  • Budigalimab — DRUG
    Lyophilized powder for solution for intravenous infusion.

Study Details

The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

Key Dates

Start date
Feb 21, 2019
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
364 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: Cohort 1 Livmoniplimab
    Various doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
  • Experimental: Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab
    Various doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
  • Experimental: Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab
    Participants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
  • Experimental: Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab
    Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
  • Experimental: Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab
    Participants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
  • Experimental: Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab
    Participants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
  • Experimental: Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab
    Participants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) \[unselected\] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
  • Experimental: Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab
    Participants with non-small cell lung cancer (NSCLC) \[programmed death ligand 1 (PDL1) relapsed/refractory (R/R)\] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
  • Experimental: Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab
    Participants with microsatellite stable colorectal cancer (MSS-CRC) \[consensus molecular subtype 4 (CMS4) enriched\] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.
  • Experimental: Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab
    Participants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.
  • Experimental: Dose Expansion: Cohort 11A Livmoniplimab + Budigalimab
    Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.
  • Experimental: Dose Expansion: Cohort 11B Livmoniplimab + Budigalimab
    Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.
  • Experimental: Dose Expansion: Cohort 11C Budigalimab
    Participants with PD-1-ref urothelial cancer will receive budigalimab Dose B administered Q3W.
  • Experimental: Dose Expansion: Cohort 12A Livmoniplimab + Budigalimab
    Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.
  • Experimental: Dose Expansion: Cohort 12B Livmoniplimab + Budigalimab
    Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.

Primary Outcome Measure

Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy [ Time Frame: Up to 28 days after the first dose of Livmoniplimab monotherapy ]

Locations (21)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group, PA /ID# 218942SpringdaleArkansas72762-
City of Hope National Medical Center /ID# 265620DuarteCalifornia91010-
City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785IrvineCalifornia92618-
Yale University School of Medicine /ID# 208356New HavenConnecticut06510-
AdventHealth Celebration /ID# 224860CelebrationFlorida34747-4970-
Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953OrlandoFlorida32804-
Community Health Network, Inc. /ID# 257032IndianapolisIndiana46250-2042-
Indiana Univ School Medicine /ID# 208384IndianapolisIndiana46202-
Univ Michigan Med Ctr /ID# 221129Ann ArborMichigan48109-
Washington University-School of Medicine /ID# 259684St LouisMissouri63110-
Intermountain Health West End Clinic Gynecologic Oncology /ID# 266171BillingsMontana59106-
Icahn School of Medicine at Mount Sinai /ID# 264653New YorkNew York10029-
NYU Langone Medical Center /ID# 209822New YorkNew York10016-6402-
Carolina BioOncology Institute /ID# 208358HuntersvilleNorth Carolina28078-
The Ohio State University - The James /ID# 217611ColumbusOhio43210-1240-
Ou Health - Stephenson Cancer Center /ID# 268826Oklahoma CityOklahoma73104-
Sarah Cannon Research Institute (SMO/Network/Consortium) /ID# 264900NashvilleTennessee37203-5755-
Renovatio clinical /ID# 265109El PasoTexas79915-1803-
NEXT Oncology /ID# 208930San AntonioTexas78229-
Renovatio Clinical /ID# 265054The WoodlandsTexas77380-3181-
University of Washington Medical Center /ID# 268854SeattleWashington98195-

Find similar trials in Springdale, AR

By research site
Highlands Oncology Group, PA· Springdale, ARCity of Hope National Medical Center· Duarte, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAYale University School of Medicine· New Haven, CTAdventHealth Celebration· Celebration, FLDuplicate_AdventHealth Cancer Institute - Orlando· Orlando, FL

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