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A Study of DF6002 Alone and in Combination With Nivolumab

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ClinicalTrials.gov Identifier: NCT04423029
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Dragonfly Therapeutics

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: DF6002 Drug: Nivolumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 473 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : July 19, 2024
Estimated Study Completion Date : December 16, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy Dose Escalation Drug: DF6002
Specified dose on specified days
Experimental: Monotherapy Dose Expansion (Melanoma) Drug: DF6002
Specified dose on specified days
Experimental: Monotherapy Dose Expansion (NSCLC) Drug: DF6002
Specified dose on specified days
Experimental: Combination Dose Escalation Drug: DF6002
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Other Name: Opdivo
Experimental: Combination Dose Expansion (Melanoma) Drug: DF6002
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Other Name: Opdivo
Experimental: Combination Dose Expansion (NSCLC) Drug: DF6002
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Other Name: Opdivo


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: During the first 3 weeks of treatment ]
    Phase 1/1b only

  2. Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC) [ Time Frame: Up to 2 years ]
    Phase 2 only


Secondary Outcome Measures :
  1. Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
  2. Severity of TEAEs [ Time Frame: Up to 2 years ]
  3. Duration of TEAEs [ Time Frame: Up to 2 years ]
  4. Number of participants with changes from baseline in clinical laboratory parameters [ Time Frame: Up to 2 years ]
  5. Number of participants with changes from baseline in electrocardiogram (ECG) parameters [ Time Frame: Up to 2 years ]
  6. Number of participants with changes from baseline in vital sign parameters [ Time Frame: Up to 2 years ]
  7. Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to 2 years ]
  8. Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to month 24 ]
  9. Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T) [ Time Frame: Up to day 28 ]
  10. Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) [ Time Frame: Up to day 28 ]
  11. Maximum serum concentration observed post-dose (Cmax) [ Time Frame: Up to day 28 ]
  12. Best overall response (BOR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Approximately one year ]
  13. Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
  14. Confirmed ORR per RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
    Phase 1/1b only

  15. Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
    Phase 2 only

  16. CBR according to RECIST 1.1 per IERC [ Time Frame: Up to 2 years ]
    Phase 2 only

  17. PFS according to RECIST 1.1 per IERC [ Time Frame: Up to 2 years ]
    Phase 2 only

  18. DOR according to RECIST 1.1 per IERC [ Time Frame: Up to month 24 ]
    Phase 2 only

  19. Unconfirmed response after 4 cycles according to RECIST 1.1 [ Time Frame: Up to 2 years ]
    Phase 2 only

  20. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Phase 2 only

  21. Serum titers of anti-DF6002 antibodies [ Time Frame: Up to 2 years ]
    Phase 2 only

  22. Serum titers of anti-nivolumab antibodies [ Time Frame: Up to 2 years ]
    Phase 2 only


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
  • ECOG performance status of 0 or 1
  • Clinical or radiological evidence of disease
  • Adequate hematological, hepatic and renal function
  • Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE ≥ 6 months from enrollment

Exclusion Criteria:

  • Concurrent anticancer treatment (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 before the start of study treatment
  • Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ
  • Rapidly progressive disease
  • Serious cardiac illness or medical conditions
  • Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423029


Contacts
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Contact: Sean Rossi 617-588-0086 sean.rossi@dragonflytx.com

Locations
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Sponsors and Collaborators
Dragonfly Therapeutics
Investigators
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Study Director: Jean-Marie Cuillerot, MD Chief Medical Officer
More Information
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Responsible Party: Dragonfly Therapeutics
ClinicalTrials.gov Identifier: NCT04423029    
Other Study ID Numbers: CA101-001
2021-000038-33 ( EudraCT Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dragonfly Therapeutics:
Advanced or Metastatic Solid Tumors
Melanoma
Non-small Cell Lung Cancer
Nivolumab
DF6002 (BMS-986415)
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action