Back to Clinical Trials

Brief Title: Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

A Phase 1/1b, 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

INTRODUCTION

  • Org Study ID: DF6002 - 001
  • Secondary ID: N/A
  • NCT ID: NCT04423029
  • Sponsor: Dragonfly Therapeutics

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.

DETAILED DESCRIPTION

Assess the safety and tolerability of subcutaneous (SC) and intravenous (IV) administration of DF6002, as monotherapy and in combination with nivolumab, and to determine the maximum tolerated dose (MTD) and recommended efficacy expansion dose (REED) of SC and IV DF6002, both as monotherapy and in combination with nivolumab, for patients with advanced (unresectable, recurrent, or metastatic) solid tumors.

  • Overall Status
    Recruiting
  • Start Date
    July 13, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with dose-limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: During the first 3 weeks of treatment

Primary Outcome 2 - Measure: Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)

Primary Outcome 2 - Timeframe: Up to 2 years

CONDITION

  • Solid Tumors

ELIGIBILITY

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

- * Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directed therapy, or any drug containing an interleukin-12 (IL-12) moiety

- * 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Trials

Role: Study Chair

Affiliation: Dragonfly Therapeutics

Overall Contact

Name: Clinical Trials

Phone: 617-588-0086

Email: [email protected]

LOCATION

Facility Status Contact
Facility: University of California Irvine
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Jennifer Valerin, MD

Facility: Yale School of Medicine
New Haven, Connecticut 06520
United States
Status: Recruiting Contact: Contact
Mario Sznol, MD

Facility: University of Miami
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
Jose Lutzky, MD

Facility: Augusta University Georgia Cancer Center
Augusta, Georgia 30912-0003
United States
Status: Recruiting Contact: Contact
Sharad Ghamande, MD

Facility: Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact: Contact
Dipesh Uprety, MD

Facility: HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota 55101
United States
Status: Recruiting Contact: Contact
Arkadiusz Dudek, MD

Facility: Atlantic Health System
Morristown, New Jersey 07960
United States
Status: Recruiting Contact: Contact
Eric Whitman
973-971-7111

Facility: Montefiore Medical Center
Bronx, New York 10467
United States
Status: Recruiting Contact: Contact
Jinyu Lu, MD

Facility: University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Jorge Garcia, MD

Facility: Rhode Island Hospital
Providence, Rhode Island 02903
United States
Status: Recruiting Contact: Contact
Benedito Carneiro, MD

Facility: SCRI - Tennessee Oncology - Saint Thomas West Clinic
Nashville, Tennessee 37205
United States
Status: Recruiting Contact: Contact
Meredith McKean, MD

Facility: University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Hussein Tawbi, MD

Facility: Huntsman Cancer Institute and Hospital
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Siwen Hu-Lieskovan, MD

Facility: USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Alexander Spira, Site 0015
703-280-5390