Status:
TERMINATED
Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors
Lead Sponsor:
OBI Pharma, Inc
Conditions:
Locally Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 activi...
Eligibility Criteria
Inclusion
- 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.
- Patients in Part B (Cohort-Expansion) must have documented Globo H H score of at least 100 from a qualified laboratory IHC assay in one of the sponsor-selected tumor types to be enrolled in the respective cohort:
- Cohort 1: Pancreatic cancer
- Cohort 2: Esophageal cancer
- Cohort 3: Gastric cancer
- Cohort 4: Colorectal cancer
- Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4).
Exclusion
- 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
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04084366
Start Date
November 25 2019
End Date
October 27 2023
Last Update
March 26 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Scripps MD Anderson Cancer Center
La Jolla, California, United States, 92037
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
West Cancer Center
Germantown, Tennessee, United States, 38138
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030