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

  • STATUS
    Recruiting
  • End date
    Dec 9, 2023
  • participants needed
    185
  • sponsor
    OBI Pharma, Inc
Updated on 4 October 2022

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 activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.

Details
Condition Locally Advanced Solid Tumor
Treatment OBI-999
Clinical Study IdentifierNCT04084366
SponsorOBI Pharma, Inc
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Hepatic
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
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 5: Basket (any solid tumor type other than those included in Cohorts 1
Cohort 4: Colorectal cancer
through 4)

Exclusion Criteria

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
Sensory or motor neuropathy of Grade 2 or greater
Has undergone a major surgical procedure (as defined by the Investigator) or
Patients with a history of solid organ transplant
significant traumatic injury within 28 days prior to the first dose of OBI 999
Receipt of any prior therapy targeting Globo H
Known hypersensitivity to OBI 999 or its excipients
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
Is receiving any concurrent prohibited medication
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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