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

ModeX Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Tumors

Treatments: Drug: MDX2004

Study type: Interventional

Funder types: Industry

Identifiers

NCT07110584

MDX-2004-101

Details and patient eligibility

About

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

Enrollment: 235 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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235 participants in 4 patient groups

Dose Escalation - Part A

Experimental group

Description:

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

Treatment:

Drug: MDX2004

Indication Optimization - Part B

Experimental group

Description:

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

Treatment:

Drug: MDX2004

Dose Optimization - Part C

Experimental group

Description:

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

Treatment:

Drug: MDX2004

Dose Expansion - Part D

Experimental group

Description:

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

Treatment:

Drug: MDX2004