Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors (NCT06239194) | Clinical Trial Compass
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
United States285 participantsStarted 2024-06-12
Plain-language summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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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 i…
What they're measuring
1
All Phases: Adverse events (AEs)
Timeframe: Baseline until end of study, up to approximately 9 months
2
Phase 1b and Phase 2a: Objective response rate of MDX2001
Timeframe: From date of enrollment until the end of treatment, up to approximately 6 months
3
Phase 1: Recommended Phase 2 dose (RP2D)
Timeframe: Baseline until end of study, up to approximately 9 months