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DNA Alkylating Agent

OBI-3424 for Solid Cancers

Phase 1 & 2

Waitlist Available

Led By Apostolia Tsimberidou, MD, PHD

Research Sponsored by OBI Pharma, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Acceptable hematologic status (without hematologic support, other than red blood cell transfusion): ANC ≥1500 cells/μL, Platelet count ≥100,000/μL, Hemoglobin ≥9.0 g/dL (prior packed red blood cell transfusion or erythropoietin support is allowed)

Must not have

Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery

Treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 3 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1 and 8 of cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective.

Who is the study for?

Adults with advanced solid tumors, including pancreatic adenocarcinoma, who have recovered from previous treatments and are in relatively good health (ECOG status 0 or 1). They must have measurable disease, acceptable organ function tests, and agree to use effective contraception. Excluded are those with certain recent treatments or surgeries, active infections requiring systemic therapy, brain metastases not well controlled, hepatocellular carcinoma (for Expansion Phase), among other criteria.

What is being tested?

The trial is testing OBI-3424 as a single agent for treating advanced solid tumors. It's an early-phase study assessing the drug's safety profile, maximum tolerated dose/recommended phase two dose (MTD/RP2D), how the body processes it (pharmacokinetics/PK), and its preliminary effectiveness against cancer.

What are the potential side effects?

While specific side effects of OBI-3424 aren't listed here due to it being a first-in-human study, common side effects for cancer drugs can include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems; liver enzyme alterations; allergic reactions; kidney function changes; and potential fertility impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My blood counts meet the required levels for treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My liver function tests are within the required range.

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My kidneys work well enough (creatinine clearance over 30 mL/min).

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I have recovered from previous treatment side effects.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not fully recovered from a major surgery done within the last 4 weeks.

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I haven't had cancer treatments like radiation or chemotherapy in the last 3 weeks.

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I do not have any ongoing serious infections needing treatment.

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I am not pregnant or breastfeeding.

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I am not taking strong medications that affect liver enzymes.

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I have had radiation therapy to over a quarter of my bone marrow.

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My brain metastases are treated and stable for 4 weeks, and I don't have leptomeningeal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1 and 8 of cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1 and 8 of cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle)

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 and 8 of cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess safety changes in electrocardiogram (ECG)

Assess safety changes of body weight.

Define the Recommended Phase 2 Dose (RP2D)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose escalation phaseExperimental Treatment1 Intervention

OBI-3424 (1.0 mg/m\^2 to 14.0 mg/m\^2) will be administered by IV infusion on Days 1 and 8 of each 21-day cycle or Day 1 of each 21-day cycle to determine the MTD and RP2D with a classic 3+3 dose escalation design.

Group II: Cohort expansion phaseExperimental Treatment1 Intervention

OBI-3424 (12 mg/m\^2) will be administered by IV infusion on Day 1 of each 21-day cycle.

0 / 13Eligibility criteria met