Trial NCT06239194
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
- Phase
- Phase 1/2
- Sponsor
- ModeX Therapeutics, An OPKO Health Company
- 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; Urothelial Carcinoma (UC); Cholangiocarcinoma; Mesothelioma; Gallbladder Cancer; Ovarian Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 0-1Performance status
* 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 diseaseCardiac
* Unresolved toxicities from previous anticancer therapy
* Prior solid organ or hematologic transplant
* Known untreated, active, or uncontrolled brain metastasesBrain metastases
* Known positivity with human immunodeficiency virus (HIV)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.
Restrictions found (4)
- Brain metastasesConditionalexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County