A Phase I, Open-Label, Dose Finding Study To Assess The Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of OBT076, A CD205-Directed Antibody-Drug Conjugate, In Recurrent And/Or Metastatic CD205 Positive Solid Tumors And In Women With CD205 Positive HER2-Negative Metastatic Breast Cancer
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
Primary Objectives: To evaluate the safety and tolerability of OBT076 To define the MTD and/or the RP2D of OBT076 Secondary Objectives: To provide preliminary efficacy data on OBT076 To characterize the PK parameters of OBT076 Exploratory Objectives: To explore potential PD parameters of OBT076: To determine the correlation of TApDC presence and clinical activity of OBT076 To establish correlations, through immuno-monitoring in peripheral blood samples, that can be used for response prediction and/or biomarker definition To evaluate the target antigen expression (CD205) in archival biopsy and fresh biopsy in at least 10 subjects to compare expression levels over time
Participant 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.
Participant has histologically and/or cytologically confirmed solid tumors.
Participant has recurrent and/or metastatic non-curative HER2-ve breast cancer (based on most recently analyzed biopsy) defined by ASCO-CAP guidelines as negative in situ hybridization test or an IHC status of 0, 1+, or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
Prior treatment with checkpoint inhibitors is allowed.
Participant has tumor that is positive for CD205 antigen by IHC staining
Participant has an ECOG performance status of 0-1.
Participant has radiological documented measurable disease (i.e., at least 1 measurable lesion as per RECIST Version 1.1).
Participant has adequate organ function
Participant has adequate bone marrow function
Participant understands and voluntarily signs an ICD prior to any study-related assessments/procedures are conducted.
Participant is able to adhere to the study visit schedule and other protocol requirements.
Participant has received any chemotherapy within 21 days prior to inclusion in the study.
Participant has received another investigational therapy within 28 days.
Participant has not recovered from the acute toxic effects (CTCAE grade ≤ 1) of prior anticancer therapy, radiation, or major surgery/significant trauma (except alopecia or other toxicities not considered a safety risk for the Participant at the Investigator's discretion).
Participant has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
Participant has had radiotherapy ≤ 4 weeks prior to starting study drug.
Participant has a history of, or current symptomatic brain metastasis.
Participant has severe renal impairment (creatinine clearance >Participant has any other malignancy within 5 years prior to randomization
Participant has a known or suspected hypersensitivity or other contraindication to any excipients used in the manufacture of OBT076.
Participant has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or NYHA class 3 or 4 congestive heart failure.
Participant has a known history or current diagnosis of HIV infection, unless on triple antiviral treatment with undetectable viral load.
Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would, in the Investigator's judgment, contraindicate Participant participation in the study (e.g., history of thromboembolic event, cardiac dysfunction, chronic pancreatitis, chronic active hepatitis).
Participant has any condition that confounds the ability to interpret data from the study.
Participant is a female of childbearing potential.
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