Spots Global Cancer Trial Database for A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors
Official Title: A Phase 1/2, Open-Label, Multicenter Study of MDK-703 as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors (ORCHID-1)
Study ID: NCT05716295
Conditions
Study Description
Brief Summary: This is an open-label, dose escalation and dose expansion study of MDK-703 as a monotherapy and in combination with other cancer therapies in adult study participants with advanced or metastatic solid tumors.
Detailed Description: This is a Phase 1/2, open-label, multicenter, dose escalation and dose expansion study evaluating MDK-703 in adult study participants with advanced or metastatic solid tumors. This study will initially commence with dose escalation to evaluate the safety/tolerability of MDK-703 as a monotherapy and in combination with other cancer therapies. Once the monotherapy and/or combination therapy maximum tolerated dose (MTD), optimal biological dose (OBD), and/or recommended dose (RD) has been determined, then dose expansion of MDK-703 may commence in select populations of interest. The study will also evaluate the anti-tumor activity and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of MDK-703 as a monotherapy and in combination with other cancer therapies.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute (Florida Cancer Specialists), Sarasota, Florida, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
NEXT Oncology Austin, Austin, Texas, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
NEXT Oncology Virginia, Fairfax, Virginia, United States
Contact Details
Name: Joseph Leveque, MD
Affiliation: Chief Medical Officer
Role: STUDY_DIRECTOR
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