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CAR T-cell Therapy
DF9001 + Nivolumab for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Dragonfly Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Awards & highlights
Summary
This trial is testing a new molecule that helps the immune system attack cancer cells. It focuses on patients with solid tumors that have a protein called EGFR. The study will determine the best dose and test its effectiveness alone and with another drug called pembrolizumab. AM0010 has been previously tested in combination with pembrolizumab for advanced cancers.
Who is the study for?
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.
What is being tested?
The trial is testing DF9001 alone and in combination with Nivolumab on patients with solid tumors that express EGFR. It has two phases: dose escalation to find the best dose of DF9001 and expansion where this dose is given to more people. The goal is to activate NK cells and T-cells against cancer.
What are the potential side effects?
Potential side effects may include immune-related reactions due to T-cell activation (like inflammation in organs), infusion reactions from the drug administration process, fatigue from energy depletion by the body's response, digestive issues as a common reaction to drugs affecting rapidly dividing cells such as those in the gut lining.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assess Overall Response Rate
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol
Number of patients with AEs and TRAEs.
+1 moreSecondary study objectives
Assess progression-free survival (PFS) for DF9001 per RECIST v1.1.
Assess the best overall response (BOR) per RECIST v1.1.
Assess the duration of response (DOR) per RECIST v1.1.
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Monotherapy DF9001 Expansion in Renal Cell CarcinomaExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20-40 patients with renal cell carcinoma (RCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Group II: Monotherapy DF9001 Expansion in Non-small Cell Lung CancerExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20-40 patients with Non-small cell lung cancer (NSCLC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Group III: Monotherapy DF9001 Expansion in Head and Neck Squamous Cell CarcinomaExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20-40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Group IV: Monotherapy DF9001 Dose EscalationExperimental Treatment1 Intervention
Dose escalation cohorts of DF9001 in sequential ascending order.
Group V: Combination Expansion of DF9001 and pembrolizumab in Renal Cell CarcinomaExperimental Treatment2 Interventions
Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling 20-40 patients with renal cell carcinoma (RCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Group VI: Combination Expansion of DF9001 and pembrolizumab in Head and Neck Squamous Cell CarcinomaExperimental Treatment2 Interventions
Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling 20-40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~6070
KEYTRUDA®
2018
Completed Phase 2
~70
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immunotherapy for solid tumors often involves targeting natural killer (NK) cells and T-cell activation signals to enhance the body's immune response against cancer cells. Treatments like those studied in the DF9001 trial aim to direct these immune cells to specific receptors on cancer cells, thereby improving their ability to recognize and destroy malignant cells.
This approach is crucial for solid tumor patients as it offers a targeted method to combat cancer, potentially leading to more effective and less toxic treatments compared to traditional chemotherapy. By harnessing the body's own immune system, these therapies can provide durable responses and improve overall survival rates.
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,741 Total Patients Enrolled
Dragonfly TherapeuticsLead Sponsor
3 Previous Clinical Trials
953 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received an organ or stem cell transplant.My liver is working well.My cancer has worsened despite treatment for its advanced stage.My colorectal cancer has returned or spread and tests show it has EGFR expression.My cancer is not known to be MMR/MSI high.My cancer progressed after treatment with anti-PD-(L)1 therapy.I do not have significant infections like HIV or active hepatitis.I have a medical history that may increase my risk of side effects from EGFR treatment.I haven't had chemotherapy, major surgery, or experimental drugs within the last 28 days.I have had or currently have inflammation or damage to my cornea.My blood counts are within a healthy range.I do not have severe heart issues, uncontrolled high blood pressure, or serious lung problems.My advanced cancer has EGFR expression and standard treatments have failed.My kidney function is normal.I've had one round of specific chemotherapy for my cancer and, if my cancer is RAS wild-type, I've also had an anti-EGFR antibody treatment.I am mostly active and my doctor expects me to live at least 3 more months.I had a heart or lung stoppage due to a temporary cause that's now gone.I haven't needed strong immune system medications for a long condition, except for stable hormone treatments.I have severe allergies to certain medications or uncontrolled asthma.My cancer is advanced or has spread, tests positive for EGFR, and has not improved with standard treatments.I have never been treated with anti-PD-(L)1 therapy.I have Stage IIIB cancer and cannot undergo curative surgery or radiotherapy.My lung cancer is at an advanced stage and has been tested positive for EGFR.My cancer returned or worsened after initial treatment with specific immune and chemotherapy drugs.I am willing to undergo two biopsies for the study.I have a tumor that can be biopsied for this study.I know my cancer's mutation status and have tried or can't try standard treatments.I am 18 years old or older.My brain metastases are stable, treated, and I don't need steroids.My cancer progressed after treatment with platinum-based chemo and anti-PD-(L)1 drugs.I haven't had cancer other than skin, low-grade prostate, or cervical in situ in the last 3 years.I have or had lung scarring or interstitial lung disease.I have mild side effects from previous treatments, but hair loss, hormone issues, or mild nerve pain is okay.I haven't had cancer treatments, major surgery, or used investigational drugs in the last 28 days.I have had anti-PD-(L)1 therapy without severe side effects.My cancer has returned or spread, is in my head or neck, and tests show it has EGFR.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Expansion of DF9001 and pembrolizumab in Renal Cell Carcinoma
- Group 2: Monotherapy DF9001 Expansion in Renal Cell Carcinoma
- Group 3: Combination Expansion of DF9001 and pembrolizumab in Head and Neck Squamous Cell Carcinoma
- Group 4: Monotherapy DF9001 Dose Escalation
- Group 5: Monotherapy DF9001 Expansion in Head and Neck Squamous Cell Carcinoma
- Group 6: Monotherapy DF9001 Expansion in Non-small Cell Lung Cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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