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

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Updated on 19 February 2024

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cancer

breast cancer

renal function

measurable disease

metastatic urothelial carcinoma

metastasis

advanced urothelial carcinoma

platinum-based chemotherapy

solid tumour

pembrolizumab

nivolumab

metastatic transitional cell carcinoma

squamous cell carcinoma of head and neck

squamous cell carcinoma

lung cancer

solid tumor

growth factor

endometrial carcinoma

lymphoma

hodgkin's disease

cancer treatment

vegf

carcinoma

triple negative breast cancer

immunomodulators

gastric cancer

esophageal cancer

esophageal carcinoma

vascular endothelial growth factor

alopecia

kidney function tests

renal function tests

neuropathy

cancer therapy

transitional cell carcinoma

solid neoplasm

pd-l1

kidney function test

immunostimulant

advanced renal cell carcinoma

programmed cell death 1 ligand 1

immunostimulants

advanced melanoma

urothelial carcinoma

braf inhibitor

advanced urothelial cancer

adjuvant

hair thinning

melanoma

squamous cell carcinoma of the skin

non-small cell lung cancer

BRAF

prostate cancer

small cell lung cancer

renal cell carcinoma

renal pelvis

cancers, ovarian

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 pembrolizumab.

Description

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 pembrolizumab 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 pembrolizumab in the following

indication

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

In each study phase, patients will receive DF6002 on Day 1 every 3 weeks (Q3W). 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

Condition	Adenocarcinoma, Adenocarcinoma, Malignant neoplasm of kidney, kidney cancer, melanoma, Metastatic Melanoma, melanoma, Transitional cell carcinoma, Renal Cell Carcinoma, Renal Cell Carcinoma, renal cell cancer, skin cancer, skin cancer, Metastatic Melanoma, Solid Tumor, kidney cancer, renal cell cancer
Age	18-100 years
Treatment	Pembrolizumab, DF6002
Clinical Study Identifier	NCT04423029
Sponsor	Dragonfly Therapeutics
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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 Expansion Inclusion Criteria
	\. Has measurable disease in one of the following tumor types: melanoma, non-
	small cell lung cancer, small cell lung cancer, head and neck squamous cell
	carcinoma , classical Hodgkin lymphoma, primary mediastinal large B-Cell
	lymphoma, urothelial carcinoma, micro-satellite instability high cancer
	gastric cancer, esophageal cancer, cervical cancer, hepatocellular cancer
	Merkel cell carcinoma, renal cell carcinoma, endometrial cancer, cutaneous T
	cell lymphoma, or triple negative breast cancer
	\. Agrees to undergo a pre-treatment biopsy and another biopsy while on
	treatment
	Inclusion Criteria for Phase 1b, DF6002 in Combination with Pembrolizumab
	Male or female patients aged 18 years
	Histologically or cytologically proven locally advanced or metastatic solid tumors
	Eligible to receive pembrolizumab per its US label
	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 the prior anti-cancer therapy to Grade 1 (Patients with Grade 2 neuropathy or Grade 2 alopecia are exceptions.)
	Additional Inclusion Criteria for Patients in the Phase 1b Expansion Cohort
	\. Has measurable disease in one of the following tumor types: melanoma
	NSCLC, SCLC, HNSCC, classical Hodgkin lymphoma, primary mediastinal large
	B-Cell lymphoma, urothelial carcinoma, micro-satellite instability high
	cancer, gastric cancer, oesophageal cancer, cervical cancer, hepatocellular
	cancer, Merkel cell carcinoma, renal cell carcinoma, endometrial cancer
	cutaneous T cell lymphoma
	\. 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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platinum-based chemotherapy

solid tumour

pembrolizumab

nivolumab

metastatic transitional cell carcinoma

squamous cell carcinoma of head and neck

squamous cell carcinoma

lung cancer

solid tumor

growth factor

endometrial carcinoma

triple negative breast cancer

vascular endothelial growth factor

alopecia

kidney function tests

renal function tests

neuropathy

cancer therapy

transitional cell carcinoma

advanced renal cell carcinoma

programmed cell death 1 ligand 1

advanced urothelial cancer

adjuvant

hair thinning

melanoma

squamous cell carcinoma of the skin

non-small cell lung cancer

BRAF

prostate cancer

small cell lung cancer

renal cell carcinoma

renal pelvis

cancers, ovarian

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