ABBV-637 + Chemotherapy for Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does the drug ABBV-637 differ from other cancer treatments?
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
Adults with relapsed/refractory solid tumors, specifically non-small cell lung cancer (NSCLC), who have tried all standard treatments can join. They must be in good physical condition (ECOG 0 or 1) and meet specific lab values. For certain parts of the study, participants need to have a history of NSCLC that has worsened after specific previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Part 1: ABBV-637 Monotherapy
Participants receive escalating doses of ABBV-637 in 28-day cycles
Treatment - Part 2: ABBV-637 + Docetaxel
Participants receive ABBV-637 in combination with docetaxel in 28-day cycles
Treatment - Part 3: ABBV-637 + Osimertinib
Participants receive ABBV-637 in combination with osimertinib in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ABBV-637
- Docetaxel
- Osimertinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois