81 Participants Needed

ABBV-637 + Chemotherapy for Cancer

Recruiting at 42 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

ABBV-637 may work differently from other cancer treatments by potentially overcoming drug resistance mechanisms, such as those involving ABC transporters, which can reduce the effectiveness of chemotherapy by pumping drugs out of cancer cells.12345

Research Team

AI

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

Your disease can be measured using specific guidelines for evaluating tumors.
I have been diagnosed with a solid tumor.
Your lab test results must meet the specific values outlined in the study's instructions.
See 6 more

Exclusion Criteria

I have side effects from cancer treatment that have not gone away, except for hair loss.
I have had serious heart issues in the last 6 months.
I have never needed steroids for lung inflammation nor do I currently have it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1: ABBV-637 Monotherapy

Participants receive escalating doses of ABBV-637 in 28-day cycles

28-day cycles
Regular visits at a hospital or clinic

Treatment - Part 2: ABBV-637 + Docetaxel

Participants receive ABBV-637 in combination with docetaxel in 28-day cycles

28-day cycles
Regular visits at a hospital or clinic

Treatment - Part 3: ABBV-637 + Osimertinib

Participants receive ABBV-637 in combination with osimertinib in 28-day cycles

28-day cycles
Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

Treatment Details

Interventions

  • ABBV-637
  • Docetaxel
  • Osimertinib
Trial OverviewThe trial is testing ABBV-637 alone or combined with Docetaxel/Osimertinib for safety and effectiveness against NSCLC. It's divided into three parts: first tests ABBV-637 solo, then its combination with Docetaxel, and finally with Osimertinib. Participants will receive cycles of treatment over approximately 28 days.
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Part 3b: ABBV-637 + OsimertinibExperimental Treatment2 Interventions
Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.
Group II: Part 3a: ABBV-637 + OsimertinibExperimental Treatment2 Interventions
Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.
Group III: Part 2b: ABBV-637 + DocetaxelExperimental Treatment2 Interventions
Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.
Group IV: Part 2a: ABBV-637 + DocetaxelExperimental Treatment2 Interventions
Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.
Group V: Part 1: ABBV-637 MonotherapyExperimental Treatment1 Intervention
Participants will receive escalating doses of ABBV-637 in 28-day cycles.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

References

Imatinib and nilotinib reverse multidrug resistance in cancer cells by inhibiting the efflux activity of the MRP7 (ABCC10). [2022]
[Chronic myelogenous leukemia]. [2015]
Cytotoxic effects of 27 anticancer drugs in HeLa and MDR1-overexpressing derivative cell lines. [2019]
Vinorelbine-based salvage chemotherapy for therapy-refractory aggressive leukaemias. [2018]
Imatinib mesylate (STI571) abrogates the resistance to doxorubicin in human K562 chronic myeloid leukemia cells by inhibition of BCR/ABL kinase-mediated DNA repair. [2015]