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
NOT_YET_RECRUITING
Denver
Florida
Dren Investigational Site
NOT_YET_RECRUITING
Orlando
Dren Investigational Site
NOT_YET_RECRUITING
Sarasota
North Carolina
Dren Investigational Site
RECRUITING
Huntersville
Oklahoma
Dren Investigational Site
NOT_YET_RECRUITING
Oklahoma City
South Carolina
Dren Investigational Site
RECRUITING
Greenville
Texas
Dren Investigational Site
RECRUITING
Austin
Dren Investigational Site
NOT_YET_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