A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Dren Bio
- Study ID
- NCT06999187
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Castrate Resistant Prostate Cancer
- Cervical Cancer
- Endometrial Cancer
- Gastric Cancer
- Gastroesophageal-junction Cancer
- HER2-negative Breast Cancer
- Head-and-neck Squamous Cell Carcinoma
- Non Small Cell Lung Cancer
- Ovarian Cancer
- Pancreatic Ductal Adenocarcinoma
- Triple Negative Breast Cancer
- Urothelial Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- DR-0202 — DRUGDR-0202 is a bispecific antibody
Study Details
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
Key Dates
- First listed
- May 31, 2025
- Start date
- Jun 3, 2025
- Status verified
- Aug 2025
- Primary completion
- Jul 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 96 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: DL1 of DR-0202Participants in this arm will receive DL1 milligrams of DR-0202 every 2 weeks until progression or withdrawal
- Experimental: DL2 of DR-0202Participants in this arm will receive DL2 milligrams of DR-0202 every 2 weeks until progression or withdrawal
- Experimental: DL3 of DR-0202Participants in this arm will receive DL3 milligrams of DR-0202 every 2 weeks until progression or withdrawal
- Experimental: DL4 of DR-0202Participants in this arm will receive DL4 milligrams of DR-0202 every 2 weeks until progression or withdrawal
- Experimental: DL5 of DR-0202Participants in this arm will receive DL5 milligrams of DR-0202 every 2 weeks until progression or withdrawal
- Experimental: DL6 of DR-0202Participants in this arm will receive DL6 milligrams of DR-0202 every 2 weeks until progression or withdrawal
- Experimental: DL7 of DR-0202Participants in this arm will receive DL7 milligrams of DR-0202 every 2 weeks until progression or withdrawal
- Experimental: DL8 of DR-0202Participants in this arm will receive DL8 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Primary Outcome Measure
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 during DR-0202 treatment through study completion (Safety and Tolerability) [ Time Frame: 28-day DLT Period and Treatment Duration / Study Completion ]
Central Contacts
- Dren Bio Central Contact415-737-5277
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dren Investigational Site | Denver | Colorado | 80218 | |
| Dren Investigational Site | Orlando | Florida | 32827 | |
| Dren Investigational Site | Sarasota | Florida | 34232 | |
| Dren Investigational Site | Huntersville | North Carolina | 28078 | |
| Dren Investigational Site | Oklahoma City | Oklahoma | 73104 | |
| Dren Investigational Site | Greenville | South Carolina | 29605 | |
| Dren Investigational Site | Austin | Texas | 78758 | |
| Dren Investigational Site | Dallas | Texas | 75230 | |
| Dren Investigational Site | San Antonio | Texas | 78229 | |
| Dren Investigational Site | Fairfax | Virginia | 22031 |
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