Dose Escalation of DF6002 in Patients With Advanced Solid Tumors and Expansion in Selected Indications

  • STATUS
    Recruiting
  • End date
    Dec 7, 2024
  • participants needed
    260
  • sponsor
    Dragonfly Therapeutics
Updated on 7 October 2020
Investigator
Sean Rossi
Primary Contact
Rhode Island Hospital (9.6 mi away) Contact
+2 other location
renal function
cancer
lymphoma
hodgkin's disease
measurable disease
carcinoma
breast cancer
squamous cell carcinoma
lung cancer
metastasis
esophageal cancer
pembrolizumab
pd-l1
programmed cell death 1 ligand 1
cancer treatment
neuropathy
solid tumour
alopecia
squamous cell carcinoma of head and neck
braf inhibitor
renal function tests
transitional cell carcinoma
platinum-based chemotherapy
advanced urothelial carcinoma
advanced renal cell carcinoma
endometrial carcinoma
kidney function test
advanced melanoma

Summary

This study is a Phase 1/2, open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab.

Description

This study is a Phase 1/2, open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab.

The study consists of 3 parts:

Phase 1: Dose-escalation as a monotherapy using a 3+3 design, with Phase 1 Cohort Expansion.

Phase 1b: Dose-escalation as a combination with nivolumab using a 3+3 design, with Phase 1b Cohort Expansion.

Phase 2: Efficacy Expansion using a group sequential design.

In Phase 2, DF6002 will be evaluated as a monotherapy in the following indications:

Cohort 2A: Advanced (unresectable or metastatic) melanoma.

Cohort 2B: Advanced (unresectable or metastatic) renal cell carcinoma (RCC).

In Phase 2, DF6002 will be evaluated in combination with nivolumab in the following

indication

Cohort C: Advanced (unresectable or metastatic) urothelial carcinoma.

In each study phase, patients will receive DF6002 on Day 1 every 4 weeks (Q4W). Patients will receive DF6002 until confirmed progressive disease (PD), unacceptable toxicity (ie, dose-limiting toxicity [DLT]), or any reason for withdrawal from the study or Investigational Medicinal Product (IMP) occurs.

Details
Treatment Pembrolizumab, Nivolumab, DF6002
Clinical Study IdentifierNCT04423029
SponsorDragonfly Therapeutics
Last Modified on7 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bronchial Neoplasm or Malignant neoplasm of kidney or Prostate Cancer or Metastatic Melanoma or Ovarian Cancer or Transitional cell carcinoma or head ...?
Male or female patients aged 18 years
Histologically or cytologically proven locally advanced or 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
Resolution of toxic effect(s) of prior anti-cancer therapy to Grade 1 (Patients with Grade 2 neuropathy or Grade 2 alopecia are exceptions)
Additional Phase 1 Monotherapy and Phase 1b Combination With Nivolumab
Expansion Inclusion Criteria
\. Has one of the following tumor types: melanoma, non-small cell lung
cancer, or triple negative breast cancer
\. Agrees to undergo a pre-treatment biopsy and another biopsy while on
treatment
Inclusion Criteria (General Phase 2)
Male or female patients aged 18 years
ECOG performance status of 0 or 1
Clinical or radiological evidence of measurable disease
Adequate hematological, hepatic and renal function
Resolution of toxic effect(s) of prior anti-cancer therapy to Grade 1. (Patients with Grade 2 neuropathy or Grade 2 alopecia are exceptions.)
Agrees to undergo a pre-treatment biopsy and another biopsy while on treatment
Additional Inclusion Criteria for Phase 2 (Advanced Melanoma Patients)
Received treatment with an anti PD-1 antibody for at least 6 weeks
Disease progression was confirmed at least 4 weeks after the initial diagnosis of disease progression while receiving an anti PD-1 antibody
Received a BRAF inhibitor if the tumor carries a BRAF activating mutation and progressed after the last line of treatment
Additional Inclusion Criteria for Phase 2 (Advanced Renal Cell Carcinoma)
Any clear cell histology component
Prior treatment with an anti PD-1/PD-L1 antibody or an anti-vascular endothelial growth factor therapy, as monotherapy or in combination
Received 3 prior lines of therapy
Additional Inclusion Criteria for Phase 2 (Advanced Urothelial Carcinoma)
Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary urothelial, urethra)
Received only one platinum-containing regimen for inoperable locally advanced or metastatic urothelial carcinoma with radiographic progression or with recurrence within 6 months after the last administration of a platinum-containing regimen as an adjuvant, which would be considered failure of a first-line, platinum-containing regimen
Received no more than 2 lines of therapy (including the platinum-containing regimen) for the treatment of metastatic disease
Have not received treatment with a check point inhibitor (ie, anti-PD-1 or anti-PD-L1) as a monotherapy or in combination with a platinum-based chemotherapy
Exclusion Criteria for All Patients (All Phases)
Prior treatment with rhIL2 or any recombinant long acting drug containing an IL2 moiety
Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy, major surgery, 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
Any Grade 2 and higher neurological or pulmonary toxicity during a treatment with an anti-PD-1 or PD-L1 agent administered as a monotherapy
Active or history of central nervous system (CNS) metastases. Melanoma patients with brain metastasis(ses) are eligible if they have been stable for 4 weeks after treatment
Receipt of any organ transplantation, autologous or allogeneic stem-cell transplantation
Significant acute or chronic infections, or active or latent hepatitis B or active hepatitis C
Preexisting autoimmune disease needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years, or clinically relevant immunodeficiencies
Known severe hypersensitivity reactions to monoclonal antibodies and any history of anaphylaxis, or uncontrolled asthma
Serious cardiac illness or medical conditions
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