Recruiting NCT07110584
Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MDX2004.
- Who it may be relevant to
- Registry conditions: Advanced Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors
Overview
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
Interventions
- Drug MDX2004
MDX2004 intravenous infusion
Primary outcome measures
- All Study Parts: Adverse Events (AEs) [Time frame: 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) [Time frame: 28 days]
- Part B, C, and D: Objective response rate of MDX2004 [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
Secondary outcome measures (12)
- All Study Parts: Measure of terminal half-life (t1/2) of MDX2004 [Time frame: 6 months]
- All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004 [Time frame: 6 months]
- All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004 [Time frame: 6 months]
- All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004 [Time frame: 6 months]
- All Study Parts: Measure of volume of distribution (Vd) of MDX2004 [Time frame: 6 months]
- All Study Parts: Measure of system clearance of MDX2004 [Time frame: 6 months]
- All Study Parts: Evaluation of MDX2004 immunogenicity [Time frame: 6 months]
- All Study Parts: Pharmacodynamic characterization of MDX2004 [Time frame: 6 months]
- All Study Parts: Duration of Response (DoR) [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
- All Study Parts: Time to Response [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
- All Study Parts: Disease Control Rate (DCR) [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
- All Study Parts: Progression Free Survival (PFS) [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Liverpool Hospital — Liverpool
- Calvary Mater Newcastle — Waratah
- Princess Alexandra Hospital — Woolloongabba
Israel · 3 centers
- Rambam Health Care Campus — Haifa
- Hadassah University Hospital-Ein Kerem — Jerusalem
- Tel Aviv Sourasky Medical Center — Tel Aviv
Identifiers
NCT: NCT07110584 · MDX-2004-101