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

Launched by MODEX THERAPEUTICS, AN OPKO HEALTH COMPANY · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called MDX2001 for patients with advanced solid tumors, which are cancers that form in organs or tissues, such as breast, lung, or colorectal cancer. The main goals are to see how safe the treatment is, how well it can be tolerated by patients, and if it helps to shrink tumors. The study is currently looking for participants, and anyone aged 18 or older with specific types of cancer may be eligible to join, provided they have measurable disease and meet other health criteria.

If you decide to participate, you will undergo regular assessments to monitor your health and the effects of the treatment. It's important to know that not everyone can join; for example, individuals with certain heart conditions, uncontrolled infections, or those currently participating in other clinical studies will be excluded. Before joining, you will be asked to give informed consent, meaning you will understand the trial details and agree to participate. This trial could be an opportunity to contribute to important research while potentially accessing a new treatment option.

Gender

ALL

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 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 infectious 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
• • The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.