Clinical Trials List
Protocol NumberOBI-992-001
Active
2024-09-01 - 2027-06-30
Phase I
Not yet recruiting1
Recruiting1
A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-992 in Subjects with Advanced Solid Tumors
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Trial Applicant
OBI PHARMA, INC.
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Sponsor
OBI Pharma, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Hong Cheng
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
• To determine the safety and tolerability
of OBI-992 when administered
intravenously (IV) to subjects with
advanced solid tumors
• To determine the maximum tolerated
dose (MTD) and optimal recommended
Phase 2 dose (RP2D) of OBI-992 using
randomized assignment to 2 dose level
cohorts and assessment of activity,
safety, and tolerability for each cohort
• To evaluate the preliminary clinical
activity profile of OBI-992 (objective
response rate [ORR], clinical benefit rate
[CBR], duration of response [DOR],
disease control rate [DCR], and
progression-free survival [PFS])
Test Drug
solution
Active Ingredient
OBI-992
Dosage Form
Dosage
47.5 mg/4.75 ml
Endpoints
Part A – Phase 1 Dose Escalation:
• Adverse events (AEs) and serious
adverse events (SAEs) and laboratory
abnormalities as graded by the National
Cancer Institute Common Terminology
Criteria for Adverse Events (NCI
CTCAE version 5.0)
• Dose-limiting toxicities (DLTs) with
OBI-992
• MTD and putative RP2D of OBI-992
Part B – Phase 2 Cohort Expansion:
• Percentage of subjects in the as-treated
population with objective response,
clinical benefit, DOR, DCR, and PFS
according to Response Evaluation
Criteria in Solid Tumors (RECIST
version 1.1) for each cohort
• AEs/SAEs and laboratory abnormalities
as graded by NCI CTCAE version 5.0
• Adverse events (AEs) and serious
adverse events (SAEs) and laboratory
abnormalities as graded by the National
Cancer Institute Common Terminology
Criteria for Adverse Events (NCI
CTCAE version 5.0)
• Dose-limiting toxicities (DLTs) with
OBI-992
• MTD and putative RP2D of OBI-992
Part B – Phase 2 Cohort Expansion:
• Percentage of subjects in the as-treated
population with objective response,
clinical benefit, DOR, DCR, and PFS
according to Response Evaluation
Criteria in Solid Tumors (RECIST
version 1.1) for each cohort
• AEs/SAEs and laboratory abnormalities
as graded by NCI CTCAE version 5.0
Inclution Criteria
1. Male or female subjects, 18 years of age or older at the time of consent
2. Provide written informed consent prior to performing any study-related procedure
3. Histologically or cytologically confirmed subjects with metastatic or advanced solid
tumor that is not curable with local therapies
4. Subjects must have been treated with established standard-of-care therapy, or
physicians have determined that such established therapy is not sufficiently
efficacious, or subjects have declined to receive standard-of-care therapy. In the latter
case, the informed consent must state the effective therapies the subject is declining.
5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation
Criteria in Solid Tumors version 1.1 [RECIST 1.1])
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Provide written informed consent prior to performing any study-related procedure
3. Histologically or cytologically confirmed subjects with metastatic or advanced solid
tumor that is not curable with local therapies
4. Subjects must have been treated with established standard-of-care therapy, or
physicians have determined that such established therapy is not sufficiently
efficacious, or subjects have declined to receive standard-of-care therapy. In the latter
case, the informed consent must state the effective therapies the subject is declining.
5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation
Criteria in Solid Tumors version 1.1 [RECIST 1.1])
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
1. 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-992
2. 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-992
3. Sensory or motor neuropathy of Grade 2 or greater
4. Subjects with a history of solid organ transplant
5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to
Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for
Adverse Events [NCI CTCAE] version 5.0), except for alopecia and laboratory values
listed in the inclusion criteria
than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior
to the first dose of OBI-992
2. 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-992
3. Sensory or motor neuropathy of Grade 2 or greater
4. Subjects with a history of solid organ transplant
5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to
Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for
Adverse Events [NCI CTCAE] version 5.0), except for alopecia and laboratory values
listed in the inclusion criteria
The Estimated Number of Participants
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Taiwan
39 participants
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Global
117 participants
