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

ENROLLING
Protocol # :
21-195
Conditions
Solid Tumors
Phase
I/II
Disease Sites
Healthy volunteer
Transplanted organ and tissue status, unspecified
Disease not specified
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Other specified personal risk factors, not elsewhere classified
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Donors
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Buchbinder, Elizabeth, I
Site Research Nurses
Combs, Sarah
Grimes, Hayley
Hart, Kayla
Mackoul, Anna
Maurer, Kimberly
O’Neill, Kailene
Treveloni, Emily

Trial Description

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.

Eligibility Requirements

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

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