Solid Tumor, AdultPhase 1/2NCT04143711
Study of DF1001 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing DF1001, Nivolumab and Nab paclitaxel in people with Solid Tumor, Adult, run by Dragonfly Therapeutics at 44 sites in 6 countries.
Trial summary
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- DF1001, Nivolumab and Nab paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 11 Nov 2019to 5 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Male or female patients aged ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
- Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 55% measured by echocardiography (preferred) or multigated acquisition (MUGA) scan.
- Adequate hematological function.
- Adequate hepatic function.
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- Adequate renal function.
- Effective contraception for women of child bearing potential (WOCBP) patients as defined by World Health Organization (WHO) guidelines for 1 "highly effective" method or 2 "effective" methods.
- Inclusion Criteria: NSCLC (HER2 Activated) Exploratory Efficacy Cohorts - Monotherapy and Combination with Sacituzumab Govitecan-hziy.
- Have progression of unresectable locally advanced or metastatic NSCLC after last systemic therapy (as confirmed by investigator) or be intolerant of last systemic therapy.
- Have HER2 overexpression status (IHC 2+ or 3+), or ERBB2 amplification, or HER2 activating mutation
- Have recurrent or progressive disease during or after platinum doublet-based chemotherapy.
- Have received and progressed on or after anti-PD-(L)1 therapy.
- Inclusion Criteria: Metastatic Breast Cancer (HR+/HER2-) Exploratory Efficacy Cohort - Monotherapy and Combination with Sacituzumab Govitecan-hziy.
- Documented evidence of HR+ metastatic breast cancer
- Documented evidence of HER2- status.
- Disease progression or recurrence after prior therapy.
- Inclusion Criteria: Metastatic Breast Cancer (HER2+) Exploratory Efficacy Cohorts - Combination with Sacituzumab Govitecan-hziy
- Have histologically confirmed HER2+ breast cancer.
- Have received prior treatment with trastuzumab, pertuzumab, ado-trastuzumab emtansine (T-DM1), or trastuzumab deruxtecan (T-DXd).
- Have progression of unresectable locally advanced metastatic breast cancer after last systemic therapy or be intolerant of last systemic therapy.
- Evidence of objective disease, but participation does not require a measurable lesion.
- Locally advanced or metastatic solid tumors, for which no standard therapy exists, or standard therapy has failed.
- HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations.
- Eligible to receive nivolumab per its label for a malignancy of epithelial origin; or
- Have no standard therapy available, or standard therapy has failed, and must not have received nivolumab prior to joining the study.
- HER2 expression by immunohistochemistry and/or ebb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.
- Patients must be eligible for treatment with nab-paclitaxel per its label, or have no standard therapy available, or standard therapy has failed.
- HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.
- Inclusion Criteria: Safety/PK/PD Expansion Cohorts (Monotherapy and Combination Therapy).
- Fresh tumor biopsy must be obtained during the screening window.
- HER2 expression by immunohistochemistry (IHC).
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Inclusion Criteria: Urothelial Bladder Cancer Expansion Cohort(s).
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary urothelial, urethra).
- Patients must have received a platinum containing chemotherapy and an anti PD-1 or anti PD-L1 for the treatment of urothelial bladder cancer.
- Inclusion Criteria: Breast Cancer (HER2 Low) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
- Histologically documented (metastatic or locally advanced) breast cancer.
- Absence of erbb2 amplification by ISH and/or HER2 IHC of 0, 1+, or 2+.
- Patient must have progressed after one line of systemic chemotherapy.
- Inclusion Criteria: Breast Cancer (HER2 High) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
- Histologically documented (metastatic or locally advanced) breast cancer.
- Erbb2 amplification by ISH and/or HER2 IHC of 3+, or 2+. If Herceptest score is 2+, ISH results should demonstrate erbb2 amplification.
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Documented history of erbb2 amplification.
- Patients must have received at least one line of an approved or established therapy.
- Inclusion Criteria: Gastric Cancer (HER2 High) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
- Tumor must have been declared HER2 positive.
- Inclusion Criteria: Gastric Cancer (HER2 Low) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
- Tumor must have been declared HER2 low; ISH non-amplified and/or HER2 IHC of 0, 1+ or 2+. If Herceptest score is 0, HER2 must be detected by IHC on at least 1+ of the tumor cells.
- Inclusion Criteria: Esophageal Cancer (HER2 High) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Advanced (unresectable/recurrent/metastatic) esophageal cancer.
- Tumor must have been declared HER2 positive.
- Inclusion Criteria: Esophageal Cancer (HER2 Low) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Advanced (unresectable/recurrent/metastatic) esophageal cancer.
- Tumor must have been declared HER2 low; ISH non-amplified and/or HER2 IHC of 0, 1+ or 2+. If Herceptest score is 0, HER2 must be detected by IHC on at least 1+ of the tumor cells.
- Inclusion Criteria: Non-small Cell Lung Cancer (HER2 Low) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease that has been confirmed to have HER2 expression (at least 1+, however, patients must not carry an erbb2 amplification) via archival or fresh biopsy tissue prior to study enrollment.
- Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy.
- Inclusion Criteria: Non-small Cell Lung Cancer (HER2 High) Expansion Cohort
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
- Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease that has been confirmed to have amplification of erbb2 via archival or fresh biopsy tissue prior to study enrollment.
- Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy.
Who cannot join
- Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days or 5 half-lives before the start of study treatment. Note: Patients receiving bisphosphonates are eligible provided treatment was initiated at least 14 days before the first dose of DF1001.
- Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- Rapidly progressive disease.
- Active or history of central nervous system (CNS) metastases.
- Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
- Significant acute or chronic infections (including historic positive test for human immunodeficiency virus [HIV], or active or latent hepatitis B or active hepatitis C tested during the screening window).
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- Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years or clinically relevant immunodeficiencies (eg, dys-gammaglobulinemia or congenital immunodeficiencies), or fever within 7 days of Day 1.
- Known severe hypersensitivity reactions to mAbs (≥ Grade 3 NCI-CTCAE v5.0), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partly controlled asthma).
- Persisting toxicity related to prior therapy > Grade 1 NCI-CTCAE v5.0, however alopecia and sensory neuropathy ≤ Grade 2 is acceptable.
- Pregnancy or lactation in females during the study.
- Known alcohol or drug abuse.
- Serious cardiac illness
- NYHA III of IV heart failure or systolic dysfunction (LVEF < 55%)
- High-risk uncontrolled arrhythmias ie, tachycardia with a heart rate > 100/min at rest
- Significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular block (AV-block; second-degree AV-block Type 2 [Mobitz 2] or third-degree AV-block)
- Angina pectoris requiring anti-anginal medication
- Clinically significant valvular heart disease
- Evidence of transmural infarction on ECG
- Poorly controlled hypertension (defined by: systolic > 180 mm Hg or diastolic > 100 mm Hg)
- Clinically relevant uncontrolled cardiac risk factors, clinically relevant pulmonary disease or any clinically relevant medical condition in the opinion of the Investigator that may limit participation in this study.
- Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
- All other significant diseases (e.g., inflammatory bowel disease), which, in the opinion of the Investigator, might impair the patient's ability to participate
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Legal incapacity or limited legal capacity.
- Incapable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol .
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
United States16 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
University of California Irvine Medical Center
Irvine, California, 92868
University of Southern California
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 53715
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Louisiana State University
New Orleans, Louisiana, 70112
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center
New York, New York, 10023
Rhode Island Hospital
Providence, Rhode Island, 02903
Sharp Healthcare
San Diego, California, 92123
University of California San Francisco
San Francisco, California, 94143
Multicare Health System Tacoma General Hospital
Tacoma, Washington, 98405
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461
University of Kansas Medical Center Research Institute, Inc.
Westwood, Kansas, 66205
South Korea9 sites
Inje University Haeundae Paik Hospital
Busan
National Cancer Center
Goyang-si
Ajou University Hospital
Gyeonggi-do
CHA Bundang Medical Center, CHA University
Gyeonggi-do
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Korea University Guro Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
France8 sites
Groupe Hospitalier Saint Andre
Bordeaux, 33000
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13009
Institut Regional du Cancer de Montepelier
Montpellier
Institut Curie
Paris, Paris, 75005
ICO - Site Rene Gauducheau
Saint-Herblain, 44805
Institut Claudius Regaud
Toulouse, 31059
Netherlands6 sites
Amsterdam University Medical Center
Amsterdam, 1081 HV
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Maasticht University Medical Center
Maastricht, 6229 HX
Radboud University Nijmegen
Nijmegen, 6525 EZ
Erasmus University Medical Center
Rotterdam, 3015 ZH
UMC Utrecht
Utrecht, 3508 GA
Belgium3 sites
Centre Hospitalier de l'Ardenne
Arlon, 6700
Grand Hopital de Charleroi
Charleroi, 6000
Domaine Universitaire du Sart Tilman; CHU de Liege
Liège, 4000
Denmark2 sites
Rigshospitalet
Copenhagen, Capital Region, 2100
Herlev og Gentofte Hospital
Herlev, 2730
About this study
Official title: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.
- Conditions
- Solid Tumor, Adult
- Being tested
- DF1001, Nivolumab, Nab paclitaxel, Sacituzumab Govitecan-hziy
- Keywords
- HER-2, NK Cell, Immunotherapy, Metastatic Breast Cancer, Non-small Cell Lung Cancer, Erbb2, DF1001, Sacituzumab Govitecan-hziy
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF1001Drug
Immunotherapy agent targeting NK cells.
NivolumabDrug
Anti-PD-1 immunotherapy agent
Nab paclitaxelDrug
A chemotherapy treatment combining paclitaxel with albumin
Sacituzumab Govitecan-hziyDrug
A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy DF1001 Dose Escalation | Experimental | Dose escalation cohorts of DF1001 in sequential ascending order. Receives: Drug: DF1001 |
| Monotherapy DF1001 Safety/PK/PD Expansion | Experimental | 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. Receives: Drug: DF1001 |
| Monotherapy DF1001 Expansion in Urothelial Bladder Cancer | Experimental | 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. Receives: Drug: DF1001 |
| Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low) | Experimental | 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. Receives: Drug: DF1001 |
| Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification | Experimental | 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. Receives: Drug: DF1001 |
| Combination Therapy with DF1001 and Nivolumab | Experimental | Combination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors. Receives: Drug: DF1001; Drug: Nivolumab |
| Combination Therapy with DF1001 and Nab-paclitaxel | Experimental | Combination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors. Receives: Drug: DF1001; Drug: Nab paclitaxel |
| Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion | Experimental | 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. Receives: Drug: DF1001; Drug: Nivolumab |
| Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion | Experimental | 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. Receives: Drug: DF1001; Drug: Nab paclitaxel |
| Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer | Experimental | 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. Receives: Drug: DF1001; Drug: Nivolumab |
| Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High) | Experimental | 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. Receives: Drug: DF1001 |
| Monotherapy DF1001 Expansion in NSCLC | Experimental | 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. Receives: Drug: DF1001 |
| Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC | Experimental | 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. Receives: Drug: DF1001; Drug: Nivolumab |
| Monotherapy DF1001 Expansion in Gastric Cancer | Experimental | 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. Receives: Drug: DF1001 |
| Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer | Experimental | 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. Receives: Drug: DF1001; Drug: Nivolumab |
| Monotherapy DF1001 Expansion in Esophageal Cancer | Experimental | 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. Receives: Drug: DF1001 |
| Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer | Experimental | 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. Receives: Drug: DF1001; Drug: Nivolumab |
| Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC | Experimental | Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documentation of HER2 activation. Receives: Drug: DF1001 |
| Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC | Experimental | 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. Receives: Drug: DF1001; Drug: Sacituzumab Govitecan-hziy |
| Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-) | Experimental | Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documentation of HR positive and HER2 negative expression. Receives: Drug: DF1001 |
| DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+) | Experimental | 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. Receives: Drug: DF1001; Drug: Sacituzumab Govitecan-hziy |
| DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-) | Experimental | 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. Receives: Drug: DF1001; Drug: Sacituzumab Govitecan-hziy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol
To assess the number of adverse events experienced during the study that meet dose limiting toxicity criteria per the study protocol.
Measured: First 3 weeks of treatment for each subject.
Assess Overall Response Rate
To assess the confirmed Overall Response Rate (ORR) per RECIST version 1.1 criteria by Investigator Assessment in the Efficacy Phase.
Measured: Through 90 days after completion of the study, an average of 1 year.
Assess number of adverse events observed during treatment with DF1001 in combination with Nivolumab
To assess the safety of DF1001 in Combination therapy with nivolumab by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: Screening visit up to 28 days after last treatment on study.
Assess number of adverse events observed during treatment with DF1001 in combination with Nab paclitaxel
To assess the safety of DF1001 in Combination therapy with Nab paclitaxel by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: Screening visit up to 28 days after last treatment on study.
Assess number of adverse events observed during treatment with DF1001 in combination with Sacituzumab govitecan-hziy
To assess the safety of DF1001 in Combination therapy with Sacituzumab govitecan-hziy by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: Screening visit up to 28 days after last treatment on study.
Secondary outcomes (7)
Evaluation of DF1001 Pharmacokinetics
Concentration vs time of DF1001 will be measured using blood samples taken a various time points on study
Measured: From start of treatment up through 28 days after last treatment.
Evaluation of DF1001 Immunogenicity
Evaluate the immunogenicity of DF1001 by measuring the number of patients developing anti-DF1001 antibodies
Measured: Every 3 weeks up to 28 days after last treatment.
Assess Overall Survival (OS) Time.
To assess Overall Survival (OS)
Measured: Time from enrollment in the study until death, measured up to 2 years after last treatment on study.
Assess Overall Response Rate by Investigator Assessment.
To assess confirmed and unconfirmed Overall Response Rate (ORR) by Investigator Assessment for patients enrolled in the dose escalation phase.
Measured: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Assess Duration of Response by Investigator Assessment.
To assess Duration of Response (DOR) for confirmed responses by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.
Measured: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Assess Best Overall Response by Investigator Assessment.
To assess confirmed Best Overall Response by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.
Measured: Through 90 days after completion of the study, an average of 1 year.
Assess Progression-free Survival by Investigator Assessment.
To assess Progression-free Survival (PFS) by Investigator Assessment for patients enrolled in the dose escalation phase and in the efficacy expansion phase.
Measured: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start11 Nov 2019
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragonfly Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143711
- Sponsor's protocol ID
- DF1001-001
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
- ClinicalTrials.gov ID
- NCT04143711
- Acronym / sponsor ID
- DF1001-001
- Conditions
- Solid Tumor, Adult
- Keywords
- HER-2, NK Cell, Immunotherapy, Metastatic Breast Cancer, Non-small Cell Lung Cancer, Erbb2, DF1001, Sacituzumab Govitecan-hziy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Dragonfly TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 22
| Arm | Type | Receives |
|---|---|---|
| Monotherapy DF1001 Dose Escalation | Experimental | Drug: DF1001Dose escalation cohorts of DF1001 in sequential ascending order. |
| Monotherapy DF1001 Safety/PK/PD Expansion | Experimental | Drug: DF1001Expansion 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. |
| Monotherapy DF1001 Expansion in Urothelial Bladder Cancer | Experimental | Drug: DF1001Monotherapy 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. |
| Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low) | Experimental | Drug: DF1001Monotherapy 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. |
| Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification | Experimental | Drug: DF1001Monotherapy 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. |
| Combination Therapy with DF1001 and Nivolumab | Experimental | Drug: DF1001, Drug: NivolumabCombination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors. |
| Combination Therapy with DF1001 and Nab-paclitaxel | Experimental | Drug: DF1001, Drug: Nab paclitaxelCombination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors. |
| Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion | Experimental | Drug: DF1001, Drug: NivolumabExpansion 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. |
| Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion | Experimental | Drug: DF1001, Drug: Nab paclitaxelExpansion 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. |
| Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer | Experimental | Drug: DF1001, Drug: NivolumabCombination 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. |
| Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High) | Experimental | Drug: DF1001Monotherapy 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. |
| Monotherapy DF1001 Expansion in NSCLC | Experimental | Drug: DF1001Monotherapy 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. |
| Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC | Experimental | Drug: DF1001, Drug: NivolumabCombination 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. |
| Monotherapy DF1001 Expansion in Gastric Cancer | Experimental | Drug: DF1001Monotherapy 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. |
| Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer | Experimental | Drug: DF1001, Drug: NivolumabCombination 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. |
| Monotherapy DF1001 Expansion in Esophageal Cancer | Experimental | Drug: DF1001Monotherapy 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. |
| Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer | Experimental | Drug: DF1001, Drug: NivolumabCombination 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. |
| Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC | Experimental | Drug: DF1001Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documentation of HER2 activation. |
| Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC | Experimental | Drug: DF1001, Drug: Sacituzumab Govitecan-hziyCombination 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. |
| Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-) | Experimental | Drug: DF1001Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documentation of HR positive and HER2 negative expression. |
| DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+) | Experimental | Drug: DF1001, Drug: Sacituzumab Govitecan-hziyCombination 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. |
| DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-) | Experimental | Drug: DF1001, Drug: Sacituzumab Govitecan-hziyCombination 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (73 listed)
- Signed written informed consent.
- Male or female patients aged ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
- Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 55% measured by echocardiography (preferred) or multigated acquisition (MUGA) scan.
- Adequate hematological function.
Key exclusion criteria (25 listed)
- Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days or 5 half-lives before the start of study treatment. Note: Patients receiving bisphosphonates are eligible provided treatment was initiated at least 14 days before the first dose of DF1001.
- Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- Rapidly progressive disease.
- Active or history of central nervous system (CNS) metastases.
- Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DF1001Immunotherapy agent targeting NK cells. | Drug | Combination Therapy with DF1001 and Nab-paclitaxel, Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion, Combination Therapy with DF1001 and Nivolumab, Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer, Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer, Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC, Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer, Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion, Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC, 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-), Monotherapy DF1001 Dose Escalation, Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification, Monotherapy DF1001 Expansion in Esophageal Cancer, Monotherapy DF1001 Expansion in Gastric Cancer, Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High), Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low), Monotherapy DF1001 Expansion in NSCLC, Monotherapy DF1001 Expansion in Urothelial Bladder Cancer, Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-), Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC, Monotherapy DF1001 Safety/PK/PD Expansion |
| NivolumabAnti-PD-1 immunotherapy agent | Drug | Combination Therapy with DF1001 and Nivolumab, Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer, Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer, Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC, Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer, Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion |
| Nab paclitaxelA chemotherapy treatment combining paclitaxel with albumin | Drug | Combination Therapy with DF1001 and Nab-paclitaxel, Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion |
| Sacituzumab Govitecan-hziyA Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate | Drug | Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC, 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-) |
Primary outcome
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol
Time frame: First 3 weeks of treatment for each subject.
To assess the number of adverse events experienced during the study that meet dose limiting toxicity criteria per the study protocol.
Assess Overall Response Rate
Time frame: Through 90 days after completion of the study, an average of 1 year.
To assess the confirmed Overall Response Rate (ORR) per RECIST version 1.1 criteria by Investigator Assessment in the Efficacy Phase.
Assess number of adverse events observed during treatment with DF1001 in combination with Nivolumab
Time frame: Screening visit up to 28 days after last treatment on study.
To assess the safety of DF1001 in Combination therapy with nivolumab by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Assess number of adverse events observed during treatment with DF1001 in combination with Nab paclitaxel
Time frame: Screening visit up to 28 days after last treatment on study.
To assess the safety of DF1001 in Combination therapy with Nab paclitaxel by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Assess number of adverse events observed during treatment with DF1001 in combination with Sacituzumab govitecan-hziy
Time frame: Screening visit up to 28 days after last treatment on study.
To assess the safety of DF1001 in Combination therapy with Sacituzumab govitecan-hziy by measuring Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
7 secondary outcomes
Evaluation of DF1001 Pharmacokinetics
Time frame: From start of treatment up through 28 days after last treatment.
Evaluation of DF1001 Immunogenicity
Time frame: Every 3 weeks up to 28 days after last treatment.
Assess Overall Survival (OS) Time.
Time frame: Time from enrollment in the study until death, measured up to 2 years after last treatment on study.
Assess Overall Response Rate by Investigator Assessment.
Time frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Assess Duration of Response by Investigator Assessment.
Time frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Assess Best Overall Response by Investigator Assessment.
Time frame: Through 90 days after completion of the study, an average of 1 year.
Assess Progression-free Survival by Investigator Assessment.
Time frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DF1001, Nivolumab and Nab paclitaxel in people with Solid Tumor, Adult, run by Dragonfly Therapeutics at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 73 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, South Korea, France, Netherlands, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol (time frame: First 3 weeks of treatment for each subject.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.