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Study of MDX2001 for Advanced Solid Tumors

This study is testing a drug called MDX2001 in people with advanced solid tumors, including biliary tract, breast, cervical, colon, and endometrial cancers. The main goals are to understand how safe MDX2001 is, what side effects it might cause, and how well it works to shrink tumors. You may be able to join if you are at least 18 years old, have a confirmed diagnosis of metastatic (spread) solid tumors, and a good general health status (ECOG performance status 0-1). The study is looking for the best dose of MDX2001 and its anti-tumor effects. The current recruitment status is unclear.

Study design
This study has three parts: Phase 1a (dose escalation), Phase 1b (dose expansion), and Phase 2a (further expansion). It plans to enroll 285 participants.
What's involved
The expected duration for each patient in the study is about 10 months, including up to 1 month for screening, about 6 months for treatment, and about 3 months for follow-up after treatment.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for adverse events (side effects) from the start of the study until the end, which is about 9 months. There is also a median of 3 months for long-term follow-up after treatment ends.

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NCT06239194

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
ModeX Therapeutics, An OPKO Health Company
~285 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:MDX2001

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All Phases: Adverse events (AEs)
Measured over Baseline until end of study, up to approximately 9 months
+2 more outcomes measured

Conditions

Biliary Tract Cancer
Breast Cancer
Cervical Cancer
Colon Cancer
Endometrial Cancer
Esophageal Cancer
Gastric Cancer
GastroEsophageal Cancer
Head and Neck Cancer
Hepatocellular Cancer
Non-small Cell Lung Cancer
Pancreatic Cancer
Prostate Cancer
Rectal Cancer
Renal Cancer
Thyroid Cancer

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Where it's being run

6 sites across 5 states
Texas2
Colorado1
Florida1
Massachusetts1
Tennessee1

Who to contact

Email recommended
[email protected]
(857) 233-9936
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Any clinically significant cardiac disease
Unresolved toxicities from previous anticancer therapy
Prior solid organ or hematologic transplant
Known untreated, active, or uncontrolled brain metastases
Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.
Receipt of a live-virus vaccination within 28 days of planned treatment start
Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
Participation in a concurrent clinical study in the treatment period.
Known hypersensitivity to MDX2001 or any of its ingredients
Supplemental oxygen use for activities of daily living

What this trial measures

  • All Phases: Adverse events (AEs)Baseline until end of study, up to approximately 9 months

    Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters

  • Phase 1b and Phase 2a: Objective response rate of MDX2001From date of enrollment until the end of treatment, up to approximately 6 months

    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.

  • Phase 1: Recommended Phase 2 dose (RP2D)Baseline until end of study, up to approximately 9 months

    Recommended Phase 2 dose is determined following the evaluation of MDX2001 safety including the incidences of dose limiting toxicities (DLTs), MDX2001 anti-tumor activity, and MDX2001 pharmacokinetics