Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2031-06-30

Brief Summary

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This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.

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Detailed Description

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Conditions

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Advanced Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation - Part A

Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion.

Group Type EXPERIMENTAL

MDX2004

Intervention Type DRUG

MDX2004 intravenous infusion

Indication Optimization - Part B

Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion.

Group Type EXPERIMENTAL

MDX2004

Intervention Type DRUG

MDX2004 intravenous infusion

Dose Optimization - Part C

Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion.

Group Type EXPERIMENTAL

MDX2004

Intervention Type DRUG

MDX2004 intravenous infusion

Dose Expansion - Part D

Participants with select advanced tumors will receive the recommended Phase 2 dose of MDX2004 as intravenous (IV) infusion.

Group Type EXPERIMENTAL

MDX2004

Intervention Type DRUG

MDX2004 intravenous infusion

Interventions

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MDX2004

MDX2004 intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant must be ≥ 18 years of age.
* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* All participants should have at least 1 measurable site of disease according to RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
* Adequate hematologic, hepatic and renal function.
* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent.

Exclusion Criteria

* Any clinically significant cardiac disease.
* Unresolved toxicities from previous anticancer therapy.
* Known untreated, active, or uncontrolled brain metastases.
* Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX2004.
* Active medical condition requiring chronic systemic steroid use (\>10 mg/day prednisone or equivalent) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2004.
* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.
* Prior solid organ or hematologic transplant
* Require supplemental oxygen for activities of daily living
* Participant is not suitable for participation, whatever the reason, as judged by the Investigator including medical or clinical conditions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No