378 Participants Needed

DF1001 for Solid Cancers

Recruiting at 49 trial locations
SR
CT
Overseen ByClinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment called DF1001-001 that helps the immune system target and destroy cancer cells. It focuses on patients with certain types of cancers that have a protein called HER2. The treatment works by activating immune cells to recognize and attack these cancer cells.

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 be on any concurrent anticancer treatments or certain other therapies, so it's best to discuss your specific medications with the trial team.

Are You a Good Fit for This Trial?

Adults with various advanced solid tumors, especially those expressing HER2. Participants must have measurable disease and adequate organ function, and women of childbearing age must use effective contraception. Excluded are individuals with recent other cancers, CNS metastases, severe heart conditions, uncontrolled infections or allergies to monoclonal antibodies.

Inclusion Criteria

My liver is working well.
I have been treated with trastuzumab, pertuzumab, and a HER2-targeting ADC.
My cancer shows a low level of HER2 protein.
See 48 more

Exclusion Criteria

My heart's pumping ability is significantly reduced.
I have mild side effects from previous treatments, but hair loss and mild nerve issues are okay.
I have not taken any drugs recently that are not allowed in the trial, but I have previously taken HER2-targeting treatments with the required break period.
See 23 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of DF1001 to determine the maximum tolerated dose

Varies per cohort

Dose Expansion

Participants receive the recommended phase 2 dose (RP2D) of DF1001, either as monotherapy or in combination with other drugs

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days after last treatment

What Are the Treatments Tested in This Trial?

Interventions

  • DF1001
  • Nab paclitaxel
  • Nivolumab
Trial Overview The trial is testing DF1001's ability to activate immune cells against cancer in two phases: dose escalation (finding the right amount) and expansion (testing that amount more broadly). It will be combined with nivolumab or Nab paclitaxel in patients whose tumors express HER2.
How Is the Trial Designed?
22Treatment groups
Experimental Treatment
Group I: Monotherapy DF1001 Safety/PK/PD ExpansionExperimental Treatment1 Intervention
Group II: Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLCExperimental Treatment1 Intervention
Group III: Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-)Experimental Treatment1 Intervention
Group IV: Monotherapy DF1001 Expansion in Urothelial Bladder CancerExperimental Treatment1 Intervention
Group V: Monotherapy DF1001 Expansion in NSCLCExperimental Treatment1 Intervention
Group VI: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)Experimental Treatment1 Intervention
Group VII: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)Experimental Treatment1 Intervention
Group VIII: Monotherapy DF1001 Expansion in Gastric CancerExperimental Treatment1 Intervention
Group IX: Monotherapy DF1001 Expansion in Esophageal CancerExperimental Treatment1 Intervention
Group X: Monotherapy DF1001 Expansion in Cancers with Erbb2 AmplificationExperimental Treatment1 Intervention
Group XI: Monotherapy DF1001 Dose EscalationExperimental Treatment1 Intervention
Group XII: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)Experimental Treatment2 Interventions
Group XIII: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+)Experimental Treatment2 Interventions
Group XIV: Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLCExperimental Treatment2 Interventions
Group XV: Combination Therapy with DF1001 and Nivolumab Safety/PK/PD ExpansionExperimental Treatment2 Interventions
Group XVI: Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder CancerExperimental Treatment2 Interventions
Group XVII: Combination Therapy with DF1001 and Nivolumab Expansion in NSCLCExperimental Treatment2 Interventions
Group XVIII: Combination Therapy with DF1001 and Nivolumab Expansion in Gastric CancerExperimental Treatment2 Interventions
Group XIX: Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal CancerExperimental Treatment2 Interventions
Group XX: Combination Therapy with DF1001 and NivolumabExperimental Treatment2 Interventions
Group XXI: Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD ExpansionExperimental Treatment2 Interventions
Group XXII: Combination Therapy with DF1001 and Nab-paclitaxelExperimental Treatment2 Interventions

DF1001 is already approved in United States for the following indications:

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Approved in United States as DF1001 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dragonfly Therapeutics

Lead Sponsor

Trials
4
Recruited
1,300+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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