Clinical trial · Interventional
Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors
A Phase 1/2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors
NCT07110584CI-TRIAL-00104811recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Tumors | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX2004 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation - Part A
- description
- Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion.
- interventionNames
- Drug: MDX2004
- type
- EXPERIMENTAL
- label
- Indication Optimization - Part B
- description
- Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion.
- interventionNames
- Drug: MDX2004
- type
- EXPERIMENTAL
- label
- Dose Optimization - Part C
- description
- Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.