Ph I/II DF1001 in Pts w/ Locally Adv or Metastatic Solid Tumors, & Expansion in Selected Indications

UCI Specialty Area: Cancer

Principal Investigator: Jennifer Brooke Valerin

Official Title: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

A Study On:

Anus

Bones and Joints

Brain and Nervous System

Breast

Cervix

Colon

Corpus Uteri

Esophagus

Eye and Orbit

Hodgkin's Lymphoma

Ill-Defined Sites

Kaposis sarcoma

Kidney

Larynx

Lip Oral Cavity and Pharynx

Liver

Lung

Melanoma skin

Multiple Myeloma

Mycosis Fungoides

Non-Hodgkin's Lymphoma

Other Digestive Organ

Other Endocrine System

Other Female Genital

Other Male Genital

Other Respiratory and Intrathoracic Organs

Other Skin

Other Urinary

Ovary

Pancreas

Prostate

Rectum

Small Intestine

Soft Tissue

Stomach

Thyroid

Unknown Sites

Urinary Bladder

Study Description

This is a Phase I/II study to see whether the study drug DF1101, is safe and tolerable for patients with locally advanced or metastatic solid tumors. Patients will be enrolled into 1 of 2 parts: Dose Escalation or Efficacy Expansion.

Dose Escalation: The main purpose of this part is to test different doses of the study drug, starting with the lowest dose and up to the highest dose. If the dose is considered safe, another group of patients will join the study to receive the study drug at a higher dose.

Efficacy Expansion: The main purose of this part is to further test the selected dose of the study drug in subjects with bladder cancer, breast cancer, or cancers that have high levels of a protein called HER2. Patients in this part of the study will receive the study drug DF1001 alone.

Eligibility

Male or female patients at least 18 years of age
Patients must have histologically or cytologically proven locally advanced or metastatic solid tumors with documented HER2 expression.

Patients must not have had receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
Significant acute or chronic infections (including positive test for HIV), or active or latent hepatitis B or active hepatitis C.
Serious cardiac illness or medical conditions.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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