A Study of DF6002 Alone and in Combination With Nivolumab

D

Dragonfly Therapeutics

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Solid Tumors

Treatments

Drug: Nivolumab
Drug: DF6002

Study type

Interventional

Funder types

Industry

Identifiers

NCT04423029
CA101-001
2021-000038-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

473 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

473 participants in 6 patient groups

Monotherapy Dose Escalation
Experimental group
Treatment:
Drug: DF6002
Monotherapy Dose Expansion (Melanoma)
Experimental group
Treatment:
Drug: DF6002
Monotherapy Dose Expansion (NSCLC)
Experimental group
Treatment:
Drug: DF6002
Combination Dose Escalation
Experimental group
Treatment:
Drug: DF6002
Drug: Nivolumab
Combination Dose Expansion (Melanoma)
Experimental group
Treatment:
Drug: DF6002
Drug: Nivolumab
Combination Dose Expansion (NSCLC)
Experimental group
Treatment:
Drug: DF6002
Drug: Nivolumab

Trial contacts and locations

53

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Central trial contact

Sean Rossi

Data sourced from clinicaltrials.gov

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