ABBV-711 + Budigalimab for Squamous Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new drug, ABBV-711, both alone and with another investigational drug, budigalimab, to determine their safety and effectiveness in treating certain advanced cancers. It targets individuals with squamous tumors, such as lung or head and neck cancer, who have already undergone other treatments. Participants should have cancer that current methods cannot cure and must have previously received specific cancer drugs. The trial requires regular visits for check-ups and tests over several years. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop certain medications before joining the trial. Specifically, you cannot have had anti-cancer therapy, certain radiation therapies, or immunosuppressive medications within a specific time frame before starting the trial. Also, you cannot use certain enzyme inhibitors or inducers during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study tested ABBV-711 alone to assess its tolerability. This study examined the drug's safety and pharmacokinetics. Although the results are preliminary, they showed that ABBV-711 was administered in increasing doses to monitor for negative side effects. Participants generally tolerated the drug without serious issues, though specific side effects were not clearly detailed in the available data.
When combined with budigalimab, research indicated that budigalimab could be administered safely at various doses, ranging from 1-10 mg/kg every two weeks to 500 mg every four weeks. Participants did not experience severe side effects, suggesting that the combination with ABBV-711 might also be safe for patients.
As this trial is in its first phase, the primary goal is to determine the treatments' safety for humans. Researchers are closely monitoring for any potential problems. The data so far suggests that the treatments are well-tolerated, but further research is needed to confirm this.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ABBV-711 and Budigalimab because of their unique approach to treating squamous cell carcinoma. Most current treatments for this condition involve surgery, radiation, or chemotherapy, which target the cancer cells but can also affect healthy cells and lead to significant side effects. ABBV-711 is a novel agent that specifically targets cancer cells, potentially sparing healthy cells and reducing side effects. Budigalimab, on the other hand, is an antibody that enhances the body’s immune response against cancer cells. Together, these treatments aim to provide a more targeted and effective approach, offering hope for improved outcomes with fewer adverse effects.
What evidence suggests that this trial's treatments could be effective for squamous cell carcinoma?
Research has shown that ABBV-711, one of the treatments in this trial, yields promising results for treating certain solid tumors when used alone. In studies, patients with squamous cell carcinoma (a type of skin cancer) achieved a complete response rate of 13% and a partial response rate of 31%. In this trial, some participants will receive ABBV-711 alone, while others will receive a combination of ABBV-711 and Budigalimab. Early evidence suggests that combining ABBV-711 with Budigalimab, which enhances the immune system's ability to fight cancer, may be beneficial. Budigalimab alone has demonstrated activity against tumors in lung and squamous cell cancers, with some patients experiencing a few months without disease progression. Overall, these treatments are still under study but offer hope for those with advanced squamous tumors.678910
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for adults with advanced squamous tumors who have tried standard treatments without success or can't receive them. They must have measurable disease and be willing to undergo biopsies if safe. Those with head and neck cancer need to consent to paired biopsies, while lung cancer patients are encouraged but not required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABBV-711 as a monotherapy or in combination with budigalimab in multiple treatment arms over the course of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-711
- Budigalimab
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