A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas

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

• Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+/HER2-/+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic

• Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available

• Radiographically measurable disease

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Life expectancy, in the opinion of the Investigator, of ≥ 3 months

• Adequate marrow reserve, renal function, and hepatic function

• Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor)

• Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available

• Willing to undergo an on-treatment biopsy if clinically feasible and not contraindicated at the time of procedure

Locations
United States
Colorado
Dren Investigational Site
RECRUITING
Denver
Florida
Dren Investigational Site
RECRUITING
Orlando
Dren Investigational Site
RECRUITING
Sarasota
North Carolina
Dren Investigational Site
RECRUITING
Huntersville
Oklahoma
Dren Investigational Site
RECRUITING
Oklahoma City
South Carolina
Dren Investigational Site
RECRUITING
Greenville
Texas
Dren Investigational Site
RECRUITING
Austin
Dren Investigational Site
RECRUITING
Dallas
Dren Investigational Site
RECRUITING
San Antonio
Virginia
Dren Investigational Site
RECRUITING
Fairfax
Contact Information
Primary
Dren Bio Central Contact
clinops@drenbio.com
415-737-5277
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 96
Treatments
Experimental: DL1 of DR-0202
Participants in this arm will receive DL1 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Experimental: DL2 of DR-0202
Participants in this arm will receive DL2 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Experimental: DL3 of DR-0202
Participants in this arm will receive DL3 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Experimental: DL4 of DR-0202
Participants in this arm will receive DL4 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Experimental: DL5 of DR-0202
Participants in this arm will receive DL5 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Experimental: DL6 of DR-0202
Participants in this arm will receive DL6 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Experimental: DL7 of DR-0202
Participants in this arm will receive DL7 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Experimental: DL8 of DR-0202
Participants in this arm will receive DL8 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Sponsors
Leads: Dren Bio

This content was sourced from clinicaltrials.gov

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