Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Locally Advanced Solid Tumor

In brief

The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.

Key facts

Study ID

NCT04084366

Run by

OBI Pharma, Inc

People needed

44

Starts

2019-11-25

Expected to finish

2023-10-27

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients, 18 years of age or older at the time of consent.
• Provide written informed consent prior to performing any study related procedure.
• Histologically or cytologically confirmed patients with advanced solid tumors.
• Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the informed consent must state the effective therapies the patient is declining.
• Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function defined as:
• a. Hepatic:
• i. Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
• ii. Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
• iii.Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)
• b. Renal:
• i. Creatinine clearance >50 mL/minute using Cockcroft Gault equation
• c. Hematologic:
• i. Absolute neutrophil count ≥1,500/µL
• ii. Platelets ≥100,000/µL
• iii. Hemoglobin ≥8 g/dL
• Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including a pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
• Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy, and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug.
• Patient not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
• Male patients must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.
• Cannot be breast feeding.
• Patients with human immunodeficiency virus (HIV) infection are eligible if CD4+ T cell counts ≥ 350 cells/uL; patients on antiretroviral therapy (ART) should be on an established dose for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
• Patients with serological evidence of chronic hepatitis B virus (HBV) infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy.
• Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification.

You may not qualify if…

• Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI 999.
• Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI 999.
• Sensory or motor neuropathy of Grade 2 or greater.
• Patients with a history of solid organ transplant.
• Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
• Receipt of any prior therapy targeting Globo H.
• Known hypersensitivity to OBI 999 or its excipients.
• Has known untreated central nervous system metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period.
• Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
• Any medical co morbidity that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
• Is receiving any concurrent prohibited medication

Where it is running

• Scripps MD Anderson Cancer Center — La Jolla, California, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• West Cancer Center — Germantown, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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