A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
AbbVie
Study ID
NCT03082209
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors
  • Cancer
  • Hematologic Malignancies

Eligibility Criteria

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

Interventions

  • ABBV-621 — DRUG
    Intravenous (IV)
  • Venetoclax — DRUG
    tablet, oral
  • Bevacizumab — DRUG
    IV infusion
  • FOLFIRI — DRUG
    IV infusion

Study Details

This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies. Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.

Key Dates

Start date
Mar 20, 2017
Status verified
Dec 2022
Primary completion
Jan 21, 2022
Completion
Jan 21, 2022

Study Design

Enrollment
153 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy combination: ABBV-621 + FOLFIRI + Bevacizumab
    Participants with KRAS-mutant CRC are administered with ABBV-621 in combination with bevacizumab plus FOLFIRI
  • Experimental: Chemotherapy combination: ABBV-621+FOLFIRI
    Participants with RAS-mutant CRC who have received one prior line of therapy will be administered ABBV-621 in combination FOLFIRI.
  • Experimental: Dose Optimization: ABBV-621 + Venetoclax for AML
    Additional participants with AML will be enrolled and will be treated with a combination of ABBV-621 and venetoclax.
  • Experimental: Dose Optimization: ABBV-621 Monotherapy for AML
    Participants with Acute Myeloid Leukemia (AML) will be treated with ABBV-621 monotherapy.
  • Experimental: Dose Optimization: ABBV-621 + Venetoclax for DLBCL
    Participants with diffuse large B-cell lymphoma (DLBCL) will be treated with a combination of ABBV-621 and venetoclax.
  • Experimental: Dose Optimization for Pancreatic Cancer
    Participants with pancreatic cancer will be treated with single-agent ABBV-621 to enable selection of the recommended Phase 2 dose (RP2D).
  • Experimental: Dose Optimization for KRAS-mutant CRC
    Participants with colorectal cancer (CRC) will be treated with single-agent ABBV-621 to enable selection of the RP2D.
  • Experimental: Dose Escalation
    ABBV-621 via intravenous administration at escalating dose levels in participants with solid tumors including Non-Hodgkin Lymphoma (NHL).

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for ABBV-621 [ Time Frame: Up to 21 days ]

Locations (10)

FacilityCityStateZIPSite coordinators
Yale University /ID# 158029New HavenConnecticut06510-
The University of Chicago Medical Center /ID# 158030ChicagoIllinois60637-1443-
Ingalls Memorial Hosp /ID# 171221HarveyIllinois60426-
Univ Michigan Med Ctr /ID# 207134Ann ArborMichigan48109-
Rhode Island Hospital /ID# 171157ProvidenceRhode Island02903-
Vanderbilt University Medical Center /ID# 215000NashvilleTennessee37232-0011-
MD Anderson Cancer Center /ID# 202187HoustonTexas77030-
Millennium Oncology /ID# 214981HoustonTexas77090-1243-
South Texas Accelerated Research Therapeutics /ID# 160574San AntonioTexas78229-
Medical College of Wisconsin /ID# 171152MilwaukeeWisconsin53226-3522-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTThe University of Chicago Medical Center· Chicago, ILIngalls Memorial Hosp· Harvey, ILUniv Michigan Med Ctr· Ann Arbor, MIRhode Island Hospital· Providence, RIVanderbilt University Medical Center· Nashville, TN

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