Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
AbbVie
Study ID
NCT05599984
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • ABBV-706 — DRUG
    Intravenous (IV) Infusion
  • Cisplatin — DRUG
    Intravenous infusion
  • Budigalimab — DRUG
    IV Infusion
  • Carboplatin — DRUG
    Intravenous infusion

Study Details

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 319 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 4 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Key Dates

Start date
Dec 5, 2022
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Part 1: ABBV-706 Monotherapy Dose Escalation
    Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 2 year treatment period.
  • Experimental: Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion
    Participants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 2 year treatment period..
  • Experimental: Part 3a: ABBV-706 + Budigalimab
    Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 2 year treatment period.
  • Experimental: Part 3b: ABBV-706 + Platinum Chemotherapy
    Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 2 year treatment period.
  • Experimental: Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors
    Participants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 2 year treatment period.
  • Experimental: Part 4b: ABBV-706 Monotherapy Dose Expansion NECs
    Participants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 2 year treatment period.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AE) [ Time Frame: Up to Approximately 2 Years ]

Locations (22)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Ctr /ID# 260129GilbertArizona85234-
City Of Hope Comprehensive Cancer Center /ID# 271295DuarteCalifornia91030-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884IrvineCalifornia92618-
Yale New Haven Hospital /ID# 246647New HavenConnecticut06510-
Georgetown University Hospital /ID# 255352Washington D.C.District of Columbia20007-
University of Chicago Medical Center /ID# 256334ChicagoIllinois60637-
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130Fort WayneIndiana46804-
University of Iowa Hospitals and Clinics /ID# 246638Iowa CityIowa52242-
Barbara Ann Karmanos Cancer In /ID# 261799DetroitMichigan48201-
Henry Ford Hospital /ID# 246648DetroitMichigan48202-
START Midwest /ID# 251257Grand RapidsMichigan49546-7062-
St. Lukes Hosp. of Kansas City /ID# 259958Kansas CityMissouri64111-
Washington University-School of Medicine /ID# 246286St LouisMissouri63110-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303New YorkNew York10065-6007-
Duke Cancer Center /ID# 246285DurhamNorth Carolina27710-
UH Cleveland Medical Center /ID# 246641ClevelandOhio44106-
Univ Oklahoma HSC /ID# 250884Oklahoma CityOklahoma73117-
Tennessee Oncology, PLLC /ID# 246283NashvilleTennessee37203-
University of Texas MD Anderson Cancer Center /ID# 246287HoustonTexas77030-
South Texas Accelerated Research Therapeutics /ID# 248946San AntonioTexas78229-
University of Utah /ID# 246640Salt Lake CityUtah84112-5500-
Northwest Medical Specialties - Tacoma /ID# 262801TacomaWashington98405-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Ctr· Gilbert, AZCity Of Hope Comprehensive Cancer Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CAYale New Haven Hospital· New Haven, CTGeorgetown University Hospital· Washington D.C., DCUniversity of Chicago Medical Center· Chicago, IL

Related Studies