A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AbbVie
Study ID
NCT02099058
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

Study Details

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

Key Dates

Start date
Jan 15, 2014
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

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

Arms

  • Experimental: Monotherapy Telisotuzumab vedotin (21-day dosing cycles)
    Telisotuzumab vedotin will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.
  • Experimental: Monotherapy Telisotuzumab vedotin(28-day dosing cycles)
    Telisotuzumab vedotin will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.
  • Experimental: Monotherapy Expansion Cohort
    Telisotuzumab vedotin will be administered every 14 days on a 28-day dosing cycle.
  • Experimental: Arm A (Telisotuzumab vedotin plus Erlotinib)
    Telisotuzumab vedotin to be evaluated with Erlotinib.
  • Experimental: Arm D (Telisotuzumab vedotin plus Nivolumab)
    Telisotuzumab vedotin to be evaluated with Nivolumab.
  • Experimental: Arm E (Telisotuzumab vedotin plus Osimertinib)
    Telisotuzumab vedotin to be evaluated with Osimertinib.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Up to 24 Months ]

Locations (21)

FacilityCityStateZIPSite coordinators
Scottsdale Healthcare /ID# 123761ScottsdaleArizona85258-4566-
City of Hope /ID# 153759DuarteCalifornia91010-
University of California, Los Angeles /ID# 148295Los AngelesCalifornia90095-
UC Irvine /ID# 165107OrangeCalifornia92868-
University of California, Davis Comprehensive Cancer Center /ID# 129805SacramentoCalifornia95817-
Univ of Colorado Cancer Center /ID# 123759AuroraColorado80045-
The University of Chicago Medical Center /ID# 136995ChicagoIllinois60637-1443-
Ingalls Memorial Hosp /ID# 165876HarveyIllinois60426-
Dana-Farber Cancer Institute /ID# 168782BostonMassachusetts02215-
Massachusetts General Hospital /ID# 129804BostonMassachusetts02114-
Duplicate_Henry Ford Health System /ID# 149857DetroitMichigan48202-
Herbert Herman Cancer Center /ID# 149858LansingMichigan48912-
Washington University-School of Medicine /ID# 143798St LouisMissouri63110-
Summit Medical Group-Florham Park /ID# 217651Florham ParkNew Jersey07932-1049-
Northwell Health - Monter Cancer Center /ID# 218170Lake SuccessNew York11042-
Montefiore Medical Park at Eastchester /ID# 218445The BronxNew York10461-
Duke Cancer Center /ID# 123763DurhamNorth Carolina27710-3000-
Tennessee Oncology, PLLC /ID# 129802NashvilleTennessee37203-
Mary Crowley Cancer Research /ID# 123760DallasTexas75230-
University of Texas MD Anderson Cancer Center /ID# 154648HoustonTexas77030-
Virginia Cancer Specialists - Fairfax /ID# 165708FairfaxVirginia22031-

Find similar trials in Scottsdale, AZ

By research site
Scottsdale Healthcare· Scottsdale, AZCity of Hope· Duarte, CAUniversity of California, Los Angeles· Los Angeles, CAUC Irvine· Orange, CAUniversity of California, Davis Comprehensive Cancer Center· Sacramento, CAUniv of Colorado Cancer Center· Aurora, CO

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