RightFit
RecruitingPhase 1 / Phase 2

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

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 month

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The median expected duration of study per patient is estimated to be 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests MDX2001 in adults with solid tumors that have spread to other parts of the body. It looks at how safe the drug is, how well people tolerate it, and how it works against tumors.

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • Tests of tissue or cells show that you have a solid tumor that has spread.
  • You can do all usual activities or can do light work despite some limits on physical activity.
  • You have at least one tumor that can be measured using study rules. A tumor treated with radiation must have grown since that treatment.
  • Any birth control use must follow local rules for people in clinical studies.
  • Your blood counts, liver, and kidneys meet the study's health requirements.
  • You can give signed consent to join the study.

Who can't join

  • You have serious heart disease or need extra oxygen for daily activities.
  • You still have side effects from past cancer treatment.
  • You have had an organ transplant or a blood-forming cell transplant.
  • You have known cancer spread to the brain that is untreated, active, or not controlled.
  • You have known HIV, active hepatitis B or C, or an uncontrolled long-term or ongoing infection needing treatment through a vein.
  • You received a live-virus vaccine within 28 days before the planned treatment start, or you have a known allergy to MDX2001 or its ingredients.
  • You are in another clinical study during the treatment period.
  • The study doctor decides that you should not take part for any reason, including a health condition.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (6)

CO

FL

MA

TN

TX