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Monoclonal Antibodies

MDX2001 for Advanced Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by ModeX Therapeutics, An OPKO Health Company

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of metastatic solid tumors

Patients must be ≥ 18 years of age

Must not have

Unresolved toxicities from previous anticancer therapy

Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectious requiring intravenous treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months

Awards & highlights

Summary

"This trial aims to understand how safe and well-tolerated MDX2001 is in patients with advanced solid tumors, as well as its effectiveness in fighting against the tumors."

Who is the study for?

Adults over 18 with advanced solid tumors like lung, breast, prostate, and various other cancers. They must have a performance status indicating they can care for themselves (ECOG 0-1) and at least one measurable tumor. Participants need proper organ function and must follow local contraception guidelines.

What is being tested?

The trial is testing MDX2001's safety, tolerability, and effectiveness against advanced solid tumors. It involves gradually increasing the dose of MDX2001 to find the highest dose patients can take without serious side effects before expanding to more participants.

What are the potential side effects?

Specific side effects are not listed but may include typical reactions to cancer treatments such as fatigue, nausea, inflammation in organs or skin reactions. The study aims to determine these side effects.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread and was confirmed by lab tests.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have no lingering side effects from past cancer treatments.

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I have HIV, active hepatitis B or C, or an uncontrolled infection needing IV treatment.

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I have had a transplant of an organ or bone marrow.

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I have a serious heart condition.

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I have brain metastases that haven't been treated.

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I have not received a live-virus vaccine in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 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

All Phases: Adverse events (AEs)

Phase 1: Recommended Phase 2 dose (RP2D)

Phase 1b and Phase 2a: Objective response rate of MDX2001

Secondary study objectives

All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001

All Phases: Disease control rate (DCR)

All Phases: Duration of response (DOR)

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2a - Cohort ExpansionExperimental Treatment1 Intervention

Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.

Group II: Phase 1b - Dose Expansion - Dose BExperimental Treatment1 Intervention

Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.

Group III: Phase 1b - Dose Expansion - Dose AExperimental Treatment1 Intervention

Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.

Group IV: Phase 1a - MDX2001 Dose EscalationExperimental Treatment1 Intervention

Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.

0 / 9Eligibility criteria met

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Who is running the clinical trial?

ModeX Therapeutics, An OPKO Health CompanyLead Sponsor

1 Previous Clinical Trials

52 Total Patients Enrolled

~77 spots leftby Aug 2028

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