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Monoclonal Antibodies
OBI-992 for Advanced Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by OBI Pharma, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects in Part B (Cohort-Expansion) - must have one of the following tumor types to be enrolled in the respective cohort: Cohort 1: Non-small cell lung cancer (NSCLC) - Pathologically confirmed subjects with metastatic NSCLC with or without actionable genomic alterations. Cohort 2: Small cell lung cancer (SCLC). Cohort 3: Gastric cancer
Histologically or cytologically confirmed subjects with metastatic or advanced solid tumor that is not curable with local therapies
Must not have
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
Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study, up to 2 years and 2 months
Awards & highlights
Summary
This trial is divided into two parts. The first part is focused on determining the highest safe dose and recommended dose of a new drug called OBI-992 when used alone. The second part aims to
Who is the study for?
This clinical trial is open to individuals with advanced solid tumors. Participants must meet specific health criteria, which are not detailed here. Those who do not fit the study's requirements or have conditions that could interfere with the trial will be excluded.
What is being tested?
The trial is testing OBI-992, a drug designed to target and kill tumor cells. It has two parts: Part A finds the highest dose patients can take without serious side effects (MTD), and Part B tests this dose in more people to see if it's safe and works against cancer.
What are the potential side effects?
Possible side effects of OBI-992 may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver issues, and other symptoms related to its anti-tumor activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer cannot be cured with surgery or radiation.
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My liver, kidney, and blood tests are within the required ranges.
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I am willing to follow all study requirements and can provide a tumor biopsy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have HIV with a CD4 count ≥ 350, on stable ART for 4 weeks, and viral load < 200 copies/mL.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery or serious injury in the last 28 days.
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I do not have serious heart problems like heart failure or unstable chest pain.
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I am not taking any medications that are not allowed in the study.
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I have moderate to severe nerve damage affecting my senses or movement.
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I don't have ongoing major side effects from cancer treatment, except for hair loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study, up to 2 years and 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study, up to 2 years and 2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose and recommended Phase 2 dose of OBI-992
Preliminary clinical activity profile - clinical benefit rate (CBR)
Preliminary clinical activity profile - disease control rate (DCR)
+4 moreSecondary study objectives
Immunogenicity of OBI-992: anti-drug antibodies (ADAs)
Serum pharmacokinetics (PK): Peak Plasma Concentration (Cmax) of OBI-992 and its active metabolite
Serum pharmacokinetics (PK): Volume distribution at steady state (Vdss) of OBI-992 and its active metabolite
+3 moreTrial Design
10Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort Expansion - Cohort 3Experimental Treatment1 Intervention
Gastric cancer indication cohort - OBI-992 dosed at putative recommended phase 2 dose.
Group II: Phase 2 Cohort Expansion - Cohort 2Experimental Treatment1 Intervention
Small cell lung cancer indication cohort - OBI-992 dosed at putative recommended phase 2 dose.
Group III: Phase 2 Cohort Expansion - Cohort 1bExperimental Treatment1 Intervention
Non-small cell lung cancer indication cohort - Randomized dose optimization cohort. Dose level to be determined by the Safety Review Committee based on data available.
Group IV: Phase 2 Cohort Expansion - Cohort 1aExperimental Treatment1 Intervention
Non-small cell lung cancer indication cohort - Randomized dose optimization cohort. Dose level to be determined by the Safety Review Committee based on data available.
Group V: Phase 1 Dose Escalation - Cohort 6Experimental Treatment1 Intervention
OBI-992 at dose level 10 mg/kg, Q3W
Group VI: Phase 1 Dose Escalation - Cohort 5Experimental Treatment1 Intervention
OBI-992 at dose level 8 mg/kg, Q3W
Group VII: Phase 1 Dose Escalation - Cohort 4Experimental Treatment1 Intervention
OBI-992 at dose level 6 mg/kg, Q3W
Group VIII: Phase 1 Dose Escalation - Cohort 3Experimental Treatment1 Intervention
OBI-992 at dose level 4 mg/kg, Q3W
Group IX: Phase 1 Dose Escalation - Cohort 2Experimental Treatment1 Intervention
OBI-992 at dose level 2 mg/kg, Q3W
Group X: Phase 1 Dose Escalation - Cohort 1Experimental Treatment1 Intervention
OBI-992 at dose level 1 mg/kg, Q3W
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Who is running the clinical trial?
OBI Pharma, IncLead Sponsor
8 Previous Clinical Trials
1,378 Total Patients Enrolled
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