No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
ModeX Therapeutics, An OPKO Health Company · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors. Participants will receive a treatment called MDX2001 to see how it affects their cancer and how well they tolerate it.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a confirmed diagnosis of metastatic solid tumors.
I have a good performance status.
I have at least 1 measurable disease.
I can use contraception as required.
I have adequate blood and organ function.
I can give signed informed consent.
You may not be able to join if
I have significant heart disease.
I have unresolved side effects from past cancer treatments.
I have had a solid organ or blood transplant.
I have active brain metastases.
I am positive for HIV or have active hepatitis B or C.
I received a live-virus vaccine within the last 28 days.
I am deemed unsuitable by the investigator.
I use supplemental oxygen for daily activities.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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 Criteria:
* 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
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
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