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DF1001 for Solid Cancers

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
Patients must have at least 1+ expression of HER2 by IHC
Patient must have progressed after one line of systemic chemotherapy
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

Study Summary

This trial is studying a new molecule, DF1001, that targets the activation signals of natural killer (NK) cells and T-cells to receptors on cancer cells. The trial will occur in two phases, with the first phase testing different doses of DF1001 on patients with various types of solid tumors to see what is the best dose. The second phase will use the best dose from the first phase on patients with either selected solid tumors, or solid tumors expressing high levels of HER2.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions related to immune activation such as inflammation in different organs, infusion-related reactions which can occur during treatment administration, fatigue, possible blood disorders and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer shows a low level of HER2 protein.
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My cancer has worsened after one chemotherapy treatment.
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My cancer has worsened despite treatment targeting PD-1/PD-L1.
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I have hormone receptor-positive cancer and it worsened despite hormone therapy.
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I am eligible for nivolumab treatment for my cancer.
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I've had a first treatment with platinum, fluoropyridine, and an anti-PD-1.
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My tumor is HER2 low based on specific tests.
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I've had chemotherapy and PD-1/PD-L1 inhibitors for bladder cancer.
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My cancer is advanced or has spread, and standard treatments have failed or don't exist.
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My cancer shows HER2 presence through a special staining test.
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I have received only one treatment for my cancer after it spread.
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My cancer has been tested and shows HER2 activity.
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My tumor is HER2 positive.
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My cancer has a known increase in the ERBB2 gene.
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My cancer tests show high levels of HER2.
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My cancer is a type of bladder cancer that has spread.
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My cancer has worsened after one chemotherapy treatment.
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My lung cancer is at an advanced stage and tests show HER2 presence without erbb2 amplification.
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My lung cancer is at an advanced stage and tests show an increase in the erbb2 gene.
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I am mostly active and my doctor thinks I have at least 3 months to live.
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I am eligible for nab-paclitaxel for my metastatic breast cancer and haven't had taxanes in the last 6 months.
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My breast cancer is confirmed by lab tests and is advanced.
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My condition worsened after my first treatment.
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My cancer has worsened after my last treatment.
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My cancer does not show high levels of HER2 protein.
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I've had a first treatment with specific drugs and trastuzumab for my cancer.
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I am 18 years old or older.
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Standard treatments have failed me, and I haven't received nivolumab before.
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My first treatment is for advanced triple-negative breast cancer.
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My cancer has worsened after my last treatment.
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My cancer came back or got worse after platinum chemotherapy.
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My cancer is advanced and cannot be removed by surgery.
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My esophageal cancer cannot be removed by surgery and may have spread.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess Overall Response Rate
Assess number of adverse events observed during treatment with DF1001 in combination with Nab paclitaxel
Assess number of adverse events observed during treatment with DF1001 in combination with Nivolumab
+2 more
Secondary outcome measures
Assess Best Overall Response by Investigator Assessment.
Assess Duration of Response by Investigator Assessment.
Assess Overall Response Rate by Investigator Assessment.
+4 more

Trial Design

22Treatment groups
Experimental Treatment
Group I: Monotherapy DF1001 Safety/PK/PD ExpansionExperimental Treatment1 Intervention
Expansion cohorts of monotherapy DF1001 in multiple dose levels after evaluation for safety in Monotherapy Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Group II: Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLCExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documentation of HER2 activation.
Group III: Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-)Experimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documentation of HR positive and HER2 negative expression.
Group IV: Monotherapy DF1001 Expansion in Urothelial Bladder CancerExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group V: Monotherapy DF1001 Expansion in NSCLCExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group VI: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)Experimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group VII: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)Experimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group VIII: Monotherapy DF1001 Expansion in Gastric CancerExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with gastric cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group IX: Monotherapy DF1001 Expansion in Esophageal CancerExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20 patients with esophageal cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group X: Monotherapy DF1001 Expansion in Cancers with Erbb2 AmplificationExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 40 patients with solid tumors showing documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group XI: Monotherapy DF1001 Dose EscalationExperimental Treatment1 Intervention
Dose escalation cohorts of DF1001 in sequential ascending order.
Group XII: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)Experimental Treatment2 Interventions
Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HR positive and HER2 negative expression.
Group XIII: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+)Experimental Treatment2 Interventions
Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HER2 positive expression.
Group XIV: Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLCExperimental Treatment2 Interventions
Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 20 patients, including safety lead-in, with non-small cell lung cancer with documentation of HER2 activation.
Group XV: Combination Therapy with DF1001 and Nivolumab Safety/PK/PD ExpansionExperimental Treatment2 Interventions
Expansion cohort of DF1001 in combination with nivolumab after evaluation for safety in the Combination Therapy with DF1001 and nivolumab Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Group XVI: Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder CancerExperimental Treatment2 Interventions
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Group XVII: Combination Therapy with DF1001 and Nivolumab Expansion in NSCLCExperimental Treatment2 Interventions
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Group XVIII: Combination Therapy with DF1001 and Nivolumab Expansion in Gastric CancerExperimental Treatment2 Interventions
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with gastric cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Group XIX: Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal CancerExperimental Treatment2 Interventions
Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with esophageal cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
Group XX: Combination Therapy with DF1001 and NivolumabExperimental Treatment2 Interventions
Combination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors.
Group XXI: Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD ExpansionExperimental Treatment2 Interventions
Expansion cohort of DF1001 in combination with nab-paclitaxel after evaluation for safety in the Combination Therapy with DF1001 and nab-paclitaxel Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Group XXII: Combination Therapy with DF1001 and Nab-paclitaxelExperimental Treatment2 Interventions
Combination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy
2019
Completed Phase 3
~550
Nab paclitaxel
2014
Completed Phase 2
~70
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Dragonfly TherapeuticsLead Sponsor
3 Previous Clinical Trials
937 Total Patients Enrolled

Media Library

DF1001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04143711 — Phase 1 & 2
Solid Tumors Research Study Groups: Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion, Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer, Combination Therapy with DF1001 and Nivolumab, Combination Therapy with DF1001 and Nab-paclitaxel, Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC, Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion, Monotherapy DF1001 Expansion in Gastric Cancer, Monotherapy DF1001 Dose Escalation, Monotherapy DF1001 Safety/PK/PD Expansion, Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low), Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification, Monotherapy DF1001 Expansion in Urothelial Bladder Cancer, Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer, Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High), Monotherapy DF1001 Expansion in NSCLC, Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC, Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer, Monotherapy DF1001 Expansion in Esophageal Cancer, Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC, Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-), DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+), DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)
Solid Tumors Clinical Trial 2023: DF1001 Highlights & Side Effects. Trial Name: NCT04143711 — Phase 1 & 2
DF1001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04143711 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main intent of this clinical research?

"The primary endpoint of the clinical trial is to quantify any dose-limiting toxicities over a 90 day period following completion. Secondary endpoints are assessing the safety profile, progression free survival rate and serum concentration levels when DF1001 is used in combination with nivolumab via National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 as well as measuring blood samples taken at various time points on study."

Answered by AI

How many participants is the clinical trial accommodating?

"A total of 220 volunteers need to be enlisted in this research from two distinct locations; University of Kansas Medical Center Research Institute, Inc. in Westwood, and University of Southern California located in Los Angeles. Those who meet the predetermined criteria can join the study."

Answered by AI

Is enrollment for this research project still available?

"Absolutely, clinicaltrials.gov has verified that this research is currently enrolling participants. It was initially advertised on November 11th 2019 and updated recently on March 21st 2022; the investigation necessitates 220 candidates from 17 medical centres."

Answered by AI

What other experiments have utilized DF1001 to assess its efficacy?

"At the moment, DF1001 is being clinically tested in 1504 trials with 298 of those studies in their final phase. While most are situated within Shanghai, there are a total 79770 worldwide locations for clinical trial involving this drug."

Answered by AI

How many locations are currently conducting this research trial?

"This particular medical trial is currently enrolling patients from 17 distinct locations, including Westwood, Los Angeles and Detroit. To minimise travel requirements for those who join the study, prospective participants should select their nearest site."

Answered by AI

What is the predominant application of DF1001 in clinical contexts?

"DF100 is a medication regularly prescribed to patients with inoperable melanoma. It may also be beneficial for those experiencing squamous cell carcinoma, high risk of recurrence, or disease progression."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of DF1001 in Patients With Advanced Solid Tumors
2019. "Study of DF1001 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04143711.
~134 spots leftby Oct 2026
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