Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AbbVie
Study ID
NCT04721015
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumors Cancer
  • Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • ABBV-637 — DRUG
    Intravenous (IV) Infusion
  • Docetaxel — DRUG
    Intravenous (IV) Infusion
  • Osimertinib — DRUG
    Oral Tablets

Study Details

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed. ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world. In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle. 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. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.

Key Dates

Start date
Feb 23, 2021
Status verified
Jun 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

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

Arms

  • Experimental: Part 1: ABBV-637 Monotherapy
    Participants will receive escalating doses of ABBV-637 in 28-day cycles.
  • Experimental: Part 2a: ABBV-637 + Docetaxel
    Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.
  • Experimental: Part 2b: ABBV-637 + Docetaxel
    Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.
  • Experimental: Part 3a: ABBV-637 + Osimertinib
    Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.
  • Experimental: Part 3b: ABBV-637 + Osimertinib
    Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer Institute /ID# 231209BostonMassachusetts02215-
Washington University-School of Medicine /ID# 225698St LouisMissouri63110-
Carolina BioOncology Institute /ID# 225358HuntersvilleNorth Carolina28078-
Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145ProvidenceRhode Island02903-4923-
South Texas Accelerated Research Therapeutics /ID# 225359San AntonioTexas78229-
Virginia Cancer Specialists - Fairfax /ID# 225693FairfaxVirginia22031-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAWashington University-School of Medicine· St Louis, MOCarolina BioOncology Institute· Huntersville, NCLifespan Cancer Institute at Rhode Island Hospital· Providence, RISouth Texas Accelerated Research Therapeutics· San Antonio, TXVirginia Cancer Specialists - Fairfax· Fairfax, VA

Related Studies