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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
Sarah Cannon Research Institute
RECRUITING
Denver
Florida
Sylvester Comprehensive Cancer Center - University of Miami Health System
RECRUITING
Miami
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
NEXT Oncology
RECRUITING
San Antonio
Contact Information
Primary
Email recommended
info@modextx.com
(857) 233-9936
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2029-02
Participants
Target number of participants: 115
Treatments
Experimental: Phase 1a - MDX2001 Dose Escalation
Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.
Experimental: Phase 1b - Dose Expansion - Dose A
Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.
Experimental: Phase 1b - Dose Expansion - Dose B
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
Experimental: Phase 2a - Cohort Expansion
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.
Sponsors
Leads: ModeX Therapeutics, An OPKO Health Company

This content was sourced from clinicaltrials.gov

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