Status and phase
Conditions
Treatments
About
The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational.
This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.
Full description
Study OBT076-001 is an open-label, Phase I, dose escalation and expansion clinical study of OBT076 in CD205+ve recurrent and/or metastatic solid tumors that are refractory to standard treatments, or for which a standard therapy is not available or not suitable or is no longer effective. The study will consist of four parts:
Parts A, B, C and D will consist mainly of 3 periods: Screening, Treatment and Follow-up periods. The treatment period with OBT076 consists of 21 days cycles. Approximately 200 patients will be enrolled across Parts A to D.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject is ≥ 18 years of age (at the time of signing the ICF) with non-curative recurrent and/or metastatic solid tumors for which a standard therapy is not available or is no longer effective.
Subject has histologically and/or cytologically confirmed solid tumors.
Subject with Breast cancer:
Subject has received a maximum of two prior lines of cytotoxic chemotherapy in the metastatic setting. Subject who received three up to five prior lines of cytotoxic chemotherapy in the metastatic setting are eligible, if the last administration of cytotoxic chemotherapy was at least 12 weeks prior to Cycle 1 Day 1
Subject has tumor that is positive for CD205 antigen by IHC staining
Subject has an ECOG performance status of 0-1.
Subject has radiological documented measurable disease (i.e., at least 1 measurable lesion as per RECIST Version 1.1).
Subject has adequate organ function
Subject has adequate bone marrow function
Subject understands and voluntarily signs an ICD prior to any study-related assessments/procedures are conducted.
Subject is able to adhere to the study visit schedule and other protocol requirements.
Subject who is a female of childbearing potential (defined as a sexually mature women, has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal for at least 12 consecutive months and is using any adequate form of birth control must:
Subject who is a sexually active male must agree to use a condom, not to donate sperm and have no plans to father a child during the study and for at least 4 months after the last dose of study drug.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
200 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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