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

NCT07110584 | Recruiting Phase 1

• 1 other identifier: MDX-2004-101
• Study Type: interventional
• Target: 235
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Advanced Tumors

Outcome Measures

Primary Outcomes (3)

• All Study Parts: Adverse Events (AEs)

  Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters

  Baseline until 90 days after the participant has the last dose of MDX2004

• Part A only - Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D)

  Maximum Tolerated Dose or Recommended Phase 2 dose is determined following the evaluation of MDX2004 safety including the incidences of dose limiting toxicities (DLTs), MDX2004 anti-tumor activity, and MDX2004 pharmacokinetics/pharmacodynamics.

  28 days

• Part B, C, and D: Objective response rate of MDX2004

  Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  From date of enrollment until the end of treatment, up to approximately 6 months

Secondary Outcomes (12)

• All Study Parts: Measure of terminal half-life (t1/2) of MDX2004

  6 months

• All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004

  6 months

• All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004

  6 months

• All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004

  6 months

• All Study Parts: Measure of volume of distribution (Vd) of MDX2004

  6 months

Study Arms (4)

Dose Escalation - Part A

EXPERIMENTAL

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

Drug: MDX2004

Indication Optimization - Part B

EXPERIMENTAL

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

Drug: MDX2004

Dose Optimization - Part C

EXPERIMENTAL

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

Drug: MDX2004

Dose Expansion - Part D

EXPERIMENTAL

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

Drug: MDX2004

Interventions

MDX2004 DRUG

MDX2004 intravenous infusion

Dose Escalation - Part A; Dose Expansion - Part D; Dose Optimization - Part C; Indication Optimization - Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModeX Therapeutics, An OPKO Health Company: lead

Study Sites (6)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Hadassah University Hospital-Ein Kerem

Jerusalem, 9574409, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Central Study Contacts

ModeX Therapeutics, An OPKO Health Company

CONTACT

+1 857-233-9936; info@modextx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

AU (3); IL (3)