Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
378 participants
INTERVENTIONAL
2019-11-11
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy DF1001 Dose Escalation
Dose escalation cohorts of DF1001 in sequential ascending order.
DF1001
Immunotherapy agent targeting NK cells.
Monotherapy DF1001 Safety/PK/PD Expansion
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.
DF1001
Immunotherapy agent targeting NK cells.
Monotherapy DF1001 Expansion in Urothelial Bladder Cancer
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.
DF1001
Immunotherapy agent targeting NK cells.
Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)
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.
DF1001
Immunotherapy agent targeting NK cells.
Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification
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.
DF1001
Immunotherapy agent targeting NK cells.
Combination Therapy with DF1001 and Nivolumab
Combination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors.
DF1001
Immunotherapy agent targeting NK cells.
Nivolumab
Anti-PD-1 immunotherapy agent
Combination Therapy with DF1001 and Nab-paclitaxel
Combination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors.
DF1001
Immunotherapy agent targeting NK cells.
Nab paclitaxel
A chemotherapy treatment combining paclitaxel with albumin
Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion
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.
DF1001
Immunotherapy agent targeting NK cells.
Nivolumab
Anti-PD-1 immunotherapy agent
Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion
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.
DF1001
Immunotherapy agent targeting NK cells.
Nab paclitaxel
A chemotherapy treatment combining paclitaxel with albumin
Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer
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.
DF1001
Immunotherapy agent targeting NK cells.
Nivolumab
Anti-PD-1 immunotherapy agent
Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)
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.
DF1001
Immunotherapy agent targeting NK cells.
Monotherapy DF1001 Expansion in NSCLC
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.
DF1001
Immunotherapy agent targeting NK cells.
Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC
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.
DF1001
Immunotherapy agent targeting NK cells.
Nivolumab
Anti-PD-1 immunotherapy agent
Monotherapy DF1001 Expansion in Gastric Cancer
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.
DF1001
Immunotherapy agent targeting NK cells.
Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer
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.
DF1001
Immunotherapy agent targeting NK cells.
Nivolumab
Anti-PD-1 immunotherapy agent
Monotherapy DF1001 Expansion in Esophageal Cancer
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.
DF1001
Immunotherapy agent targeting NK cells.
Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer
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.
DF1001
Immunotherapy agent targeting NK cells.
Nivolumab
Anti-PD-1 immunotherapy agent
Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC
Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documentation of HER2 activation.
DF1001
Immunotherapy agent targeting NK cells.
Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC
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.
DF1001
Immunotherapy agent targeting NK cells.
Sacituzumab Govitecan-hziy
A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate
Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-)
Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documentation of HR positive and HER2 negative expression.
DF1001
Immunotherapy agent targeting NK cells.
DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+)
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.
DF1001
Immunotherapy agent targeting NK cells.
Sacituzumab Govitecan-hziy
A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate
DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)
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.
DF1001
Immunotherapy agent targeting NK cells.
Sacituzumab Govitecan-hziy
A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate
Interventions
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DF1001
Immunotherapy agent targeting NK cells.
Nivolumab
Anti-PD-1 immunotherapy agent
Nab paclitaxel
A chemotherapy treatment combining paclitaxel with albumin
Sacituzumab Govitecan-hziy
A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients aged ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
4. Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 55% measured by echocardiography (preferred) or multigated acquisition (MUGA) scan.
5. Adequate hematological function.
6. Adequate hepatic function.
7. Adequate renal function.
8. 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.
1. Have progression of unresectable locally advanced or metastatic NSCLC after last systemic therapy (as confirmed by investigator) or be intolerant of last systemic therapy.
2. Have HER2 overexpression status (IHC 2+ or 3+), or ERBB2 amplification, or HER2 activating mutation
3. Have recurrent or progressive disease during or after platinum doublet-based chemotherapy.
4. Have received and progressed on or after anti-PD-(L)1 therapy.
1. Documented evidence of HR+ metastatic breast cancer
2. Documented evidence of HER2- status.
3. Disease progression or recurrence after prior therapy.
1. Have histologically confirmed HER2+ breast cancer.
2. Have received prior treatment with trastuzumab, pertuzumab, ado-trastuzumab emtansine (T-DM1), or trastuzumab deruxtecan (T-DXd).
3. Have progression of unresectable locally advanced metastatic breast cancer after last systemic therapy or be intolerant of last systemic therapy.
1. Evidence of objective disease, but participation does not require a measurable lesion.
2. Locally advanced or metastatic solid tumors, for which no standard therapy exists, or standard therapy has failed.
3. HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations.
1. Eligible to receive nivolumab per its label for a malignancy of epithelial origin; or
2. Have no standard therapy available, or standard therapy has failed, and must not have received nivolumab prior to joining the study.
3. HER2 expression by immunohistochemistry and/or ebb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.
1. Patients must be eligible for treatment with nab-paclitaxel per its label, or have no standard therapy available, or standard therapy has failed.
2. HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.
1. Fresh tumor biopsy must be obtained during the screening window.
2. HER2 expression by immunohistochemistry (IHC).
3. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary urothelial, urethra).
3. Patients must have received a platinum containing chemotherapy and an anti PD-1 or anti PD-L1 for the treatment of urothelial bladder cancer.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
2. Histologically documented (metastatic or locally advanced) breast cancer.
3. Absence of erbb2 amplification by ISH and/or HER2 IHC of 0, 1+, or 2+.
4. Patient must have progressed after one line of systemic chemotherapy.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1
2. Histologically documented (metastatic or locally advanced) breast cancer.
3. Erbb2 amplification by ISH and/or HER2 IHC of 3+, or 2+. If Herceptest score is 2+, ISH results should demonstrate erbb2 amplification.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Documented history of erbb2 amplification.
3. Patients must have received at least one line of an approved or established therapy.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
3. Tumor must have been declared HER2 positive.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) gastric cancer or cancer of the gastro-esophageal junction.
3. 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.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) esophageal cancer.
3. Tumor must have been declared HER2 positive.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. Advanced (unresectable/recurrent/metastatic) esophageal cancer.
3. 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.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. 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.
3. Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy.
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
2. 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.
3. Patients must have recurrent or progressive disease during or after platinum doublet-based chemotherapy.
Exclusion Criteria
2. 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.
3. Rapidly progressive disease.
4. Active or history of central nervous system (CNS) metastases.
5. Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
6. 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).
7. 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.
8. 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).
9. Persisting toxicity related to prior therapy \> Grade 1 NCI-CTCAE v5.0, however alopecia and sensory neuropathy ≤ Grade 2 is acceptable.
10. Pregnancy or lactation in females during the study.
11. Known alcohol or drug abuse.
12. Serious cardiac illness
13. NYHA III of IV heart failure or systolic dysfunction (LVEF \< 55%)
14. High-risk uncontrolled arrhythmias ie, tachycardia with a heart rate \> 100/min at rest
15. 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)
16. Angina pectoris requiring anti-anginal medication
17. Clinically significant valvular heart disease
18. Evidence of transmural infarction on ECG
19. Poorly controlled hypertension (defined by: systolic \> 180 mm Hg or diastolic \> 100 mm Hg)
20. 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.
21. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
22. All other significant diseases (e.g., inflammatory bowel disease), which, in the opinion of the Investigator, might impair the patient's ability to participate
23. Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
24. Legal incapacity or limited legal capacity.
25. 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 .
18 Years
ALL
No
Sponsors
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Dragonfly Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of California Irvine Medical Center
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
Sharp Healthcare
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
University of Kansas Medical Center Research Institute, Inc.
Westwood, Kansas, United States
Louisiana State University
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center
New York, New York, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Multicare Health System Tacoma General Hospital
Tacoma, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Centre Hospitalier de l'Ardenne
Arlon, , Belgium
Grand Hopital de Charleroi
Charleroi, , Belgium
Domaine Universitaire du Sart Tilman; CHU de Liege
Liège, , Belgium
Rigshospitalet
Copenhagen, Capital Region, Denmark
Herlev og Gentofte Hospital
Herlev, , Denmark
Institut Curie
Paris, Paris, France
Groupe Hospitalier Saint Andre
Bordeaux, , France
Centre Georges-Francois Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Institut Regional du Cancer de Montepelier
Montpellier, , France
Groupe Hospitalier Pitie Salpetriere
Paris, , France
CHU de Rennes Hopital Pontechaillou
Rennes, , France
ICO - Site Rene Gauducheau
Saint-Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Amsterdam University Medical Center
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Maasticht University Medical Center
Maastricht, , Netherlands
Radboud University Nijmegen
Nijmegen, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Inje University Haeundae Paik Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
National Cancer Center
Goyang-si, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
CHA Bundang Medical Center, CHA University
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jennifer Valerin, M.D.
Role: primary
Anthony El-Khoueiry, M.D.
Role: primary
Charles Redfern, M.D.
Role: primary
Pamela Munster, MD
Role: primary
Agustin Garcia, M.D.
Role: primary
Vincent Lam, M.D.
Role: primary
Eric Feldman, M.D.
Role: primary
Alberto J Montero, M.D., MBA
Role: primary
Robert Wesolowski, M.D.
Role: primary
Howard Safran, M.D.
Role: primary
Jordan Berlin, M.D.
Role: primary
Ecaterina Dumbrava, M.D.
Role: primary
Nataliya Uboha, M.D.
Role: primary
Frederic Forget, M.D.
Role: primary
David Schroder, M.D.
Role: primary
Christine Gennigens, M.D.
Role: primary
Kristoffer Rohrberg, M.D.
Role: primary
Rikke Eefsen, M.D.
Role: primary
Emanuela Romano, M.D.
Role: primary
Alain Ravaud, M.D.
Role: primary
Francois Ghiringhelli, MD
Role: primary
Nicolas Penel, M.D.
Role: primary
Phillippe Cassier, M.D.
Role: primary
Cecile Vicier, M.D.
Role: primary
Diego Tosi, MD
Role: primary
Aurore Vozy, MD
Role: primary
Lena Herve, MD
Role: primary
Mario Campone, M.D.
Role: primary
Carlos-Alberto Gomez-Roca, M.D.
Role: primary
Il-hwan Kim, MD
Role: primary
Seong-Hoon Shin, MD
Role: primary
Keun Seok Lee, MD
Role: primary
Tae Hwan Kim, MD
Role: primary
Yong Wha Moon, MD
Role: primary
Jee Hyun Kim, MD
Role: primary
Sung Bae Kim, MD
Role: primary
In Hae Park, MD
Role: primary
Kyung-Hung Lee, MD
Role: primary
Min Hwan Kim, MD
Role: primary
Sook Hee Hong, MD
Role: primary
Other Identifiers
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DF1001-001
Identifier Type: -
Identifier Source: org_study_id
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