CTX-471 + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment for individuals with advanced cancers that have worsened despite other PD-1 or PD-L1 inhibitor drugs. The study will examine the effects of a new drug, CTX-471 (an experimental treatment), alone or combined with pembrolizumab (a type of immunotherapy). The trial seeks participants with specific cancers, such as lung cancer or melanoma, whose conditions have progressed despite previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic therapy with immunosuppressive agents within 7 days before starting the trial treatment. It's best to discuss your current medications with the study team to understand any specific requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found CTX-471 to be safe and well-tolerated, with patients experiencing only mild liver issues, which is an improvement over similar treatments. When combined with pembrolizumab (KEYTRUDA®), research showed a decrease in certain proteins that can increase inflammation, suggesting the combination might also be safe.
As a Phase 1 trial, this marks the first time the treatment is tested in humans. This phase focuses on safety, so some uncertainty remains. However, the early findings are promising.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of CTX-471 and pembrolizumab for cancer treatment because it offers a novel approach to boosting the immune system's ability to fight tumors. Unlike traditional chemotherapy, which directly attacks cancer cells, CTX-471 is an antibody that targets the CD137 receptor on immune cells, potentially enhancing their activity against cancer. When combined with pembrolizumab, a well-known immune checkpoint inhibitor, this treatment may provide a stronger and more targeted immune response, especially for challenging cancers like non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and melanoma. This dual-action strategy could lead to improved outcomes for patients who have limited options with current treatments.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that CTX-471, a new type of antibody, delivers promising results in early tests. It effectively targets tumors that typically resist other treatments. Initial human studies suggest that CTX-471 is safe and well-tolerated by patients. In this trial, some participants will receive CTX-471 alone, while others will receive it in combination with pembrolizumab, a current cancer treatment, to assess their combined effectiveness. Early results from this combination have demonstrated a decrease in substances that cause inflammation and can exacerbate cancer. While further research is necessary, these early findings offer hope for those seeking new treatments for advanced cancers.12467
Who Is on the Research Team?
Thomas Scheutz, MD, PhD
Principal Investigator
Compass Therapeutics
Are You a Good Fit for This Trial?
Adults with certain advanced cancers (like lung, melanoma, or head and neck) that worsened after PD-1/PD-L1 inhibitor treatment can join. They must have good organ function, no recent immunosuppressants or vaccines, not be pregnant or breastfeeding, and agree to use birth control. Excluded are those with severe heart issues, active infections like hepatitis B/C or HIV unless controlled, other recent cancer treatments or live vaccines.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CTX-471 as a monotherapy or in combination with pembrolizumab, with dose escalation and expansion phases
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CTX-471
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Compass Therapeutics
Lead Sponsor
Iqvia Pty Ltd
Industry Sponsor
Ari Bousbib
Iqvia Pty Ltd
Chief Executive Officer since 2016
MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris
Jeffrey Spaeder
Iqvia Pty Ltd
Chief Medical Officer
MD
Merck, Sharp & Dohme, LLC, Rahway, NJ USA
Collaborator