Actively Recruiting
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
Led by Dren Bio · Updated on 2026-01-07
96
Participants Needed
10
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed epithelial cancer of breast (TNBC, HR+/HER2-/+), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic
- Relapsed or refractory disease with at least 2 prior lines of therapy and no standard care options available
- Radiographically measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months as judged by the Investigator
- Adequate marrow, kidney, and liver function
- Tapered off high-dose systemic corticosteroids for at least 2 weeks; low-dose corticosteroids (≤ 25 mg prednisone daily) allowed with Medical Monitor approval
- Willingness to provide archival tumor tissue or undergo baseline biopsy if tissue is unavailable
- Willingness to undergo on-treatment biopsy if clinically feasible and safe
You will not qualify if you...
- Major surgery within 28 days before starting treatment
- Insufficient washout period from prior systemic therapies including chemotherapy or anticancer agents
- Antibody-based anticancer therapy within 4 weeks before treatment
- Radiation therapy within 21 days before treatment, except palliative radiation with Medical Monitor approval
- Untreated or symptomatic brain metastases requiring steroids or anticonvulsants
- Active grade 2 or higher anorexia, nausea, vomiting, or intestinal obstruction
- Other malignancies except certain treated skin cancers or in situ diseases with no evidence of disease for at least 1 year
- Significant uncontrolled diseases that might affect study compliance
- History of serious central nervous system diseases or recent stroke
- QTcF interval over 480 msec or risk factors for Torsades de Pointes
- Uncontrolled or significant cardiovascular disease or recent myocardial infarction
- Prior solid organ transplant
- Known HIV, HBV, or HCV infection without appropriate viral control
- Active infections requiring systemic treatment within 2 weeks before treatment
- Active interstitial pneumonitis within 6 months before treatment
- Other medical or psychiatric conditions that may interfere with study participation or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Dren Investigational Site
Denver, Colorado, United States, 80218
Actively Recruiting
2
Dren Investigational Site
Orlando, Florida, United States, 32827
Actively Recruiting
3
Dren Investigational Site
Sarasota, Florida, United States, 34232
Actively Recruiting
4
Dren Investigational Site
Huntersville, North Carolina, United States, 28078
Actively Recruiting
5
Dren Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
6
Dren Investigational Site
Greenville, South Carolina, United States, 29605
Actively Recruiting
7
Dren Investigational Site
Austin, Texas, United States, 78758
Actively Recruiting
8
Dren Investigational Site
Dallas, Texas, United States, 75230
Actively Recruiting
9
Dren Investigational Site
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Dren Investigational Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
D
Dren Bio Central Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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