DF9001 + Nivolumab for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called DF9001, which activates specific immune cells to target cancer cells. The study targets individuals with certain solid tumors that express a protein called EGFR. It includes two phases: the first determines the optimal dose, and the second tests that dose in various cancers, such as renal cell carcinoma and head and neck cancer. Eligible participants include those with EGFR-positive tumors who have experienced cancer progression despite previous treatments. As a Phase 1 and Phase 2 trial, this research aims to understand how DF9001 works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to receive this innovative treatment.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, radiotherapy, or major surgery within 28 days before starting the study treatment. You also cannot be on chronic systemic steroid therapy or other immunosuppressive therapy within 7 days prior to the first dose. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the safety of DF9001, a new treatment targeting cancer cells, remains under investigation. This treatment undergoes testing both alone and in combination with pembrolizumab, a drug already approved for cancer. Unfortunately, limited information exists on how well individuals tolerate DF9001 alone or with pembrolizumab.
The trial is in its early stages, so scientists are still gathering data on its safety in humans. These early trials aim to determine the treatment's safety and potential side effects. Since the treatment is still under evaluation, participants should be aware that its safety is not yet fully understood.
Pembrolizumab, when used alone, is an approved treatment for some cancers and is generally well-tolerated. However, combining it with DF9001 is new, so the safety of this combination remains uncertain. Prospective participants should consult their doctor to understand the implications of joining this clinical trial.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for cancers like renal cell carcinoma, head and neck squamous cell carcinoma, and non-small cell lung cancer, which typically involve surgery, radiation, and various chemotherapy drugs, DF9001 offers a novel approach as an experimental therapy. DF9001 is designed to be used both alone and in combination with checkpoint inhibitors like pembrolizumab. This combination aims to enhance the body's immune response against tumors more effectively. By targeting specific pathways in the immune system, DF9001 could potentially offer improved outcomes with fewer side effects compared to traditional treatments. Researchers are excited about DF9001 because it represents a new class of treatment that may unlock more personalized and effective cancer care.
What evidence suggests that this trial's treatments could be effective for solid tumors?
Research has shown that DF9001 helps fight cancer by boosting the activity of natural killer and T-cells, key components of the immune system. This approach aims to halt tumor growth and enhance the body's cancer-fighting ability. Early studies found DF9001 more effective at combating tumors than cetuximab, a common treatment, because it targets EGFR, a protein on some cancer cells. In this trial, researchers are testing DF9001 combined with pembrolizumab for kidney cancer (Renal Cell Carcinoma) and certain head and neck cancers (Head and Neck Squamous Cell Carcinoma). Another similar drug, nivolumab, has successfully treated these cancers by slowing tumor growth and extending patient survival. These findings suggest that DF9001, whether used alone or with other treatments, could benefit certain cancer types.12367
Are You a Good Fit for This Trial?
Adults with various advanced solid tumors expressing EGFR, who have progressed after anti-PD-(L)1 therapy and other standard treatments. They must be able to undergo biopsies, have an ECOG status of 0 or 1, adequate organ function, and use effective contraception. Excluded are those with recent cancer therapies or surgeries, active infections like HIV/Hepatitis B/C, certain autoimmune diseases or severe allergies to monoclonal antibodies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive DF9001 in sequential ascending doses to determine the recommended phase 1b dose
Dose Expansion
Participants receive the recommended phase 1b dose of DF9001, either as monotherapy or in combination with pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are assessed for overall response rate and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- DF9001
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dragonfly Therapeutics
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University