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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study, up to 2 years and 2 months for reporting.

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 more

Secondary 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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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