Actively Recruiting
A Phase 1a/1b Multicenter, Open-label Study Evaluating Safety and Activity 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
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates DR-0202, a bispecific antibody, in patients with locally advanced or metastatic, relapsed or refractory carcinomas. It is a phase 1a/1b, multicenter, open-label study focused on evaluating the safety and activity of DR-0202 in several types of epithelial cancers including breast, lung, cervical, prostate, pancreatic, head-and-neck, endometrial, ovarian, gastric, gastroesophageal-junction, and urothelial cancers. The study aims to provide information for patients who have relapsed or are refractory after at least two prior therapies and have no standard treatment options left. Participants will receive DR-0202 at varying dose levels (DL1 through DL8) administered every two weeks until disease progression or withdrawal from the study. This dose escalation and expansion study allows researchers to explore multiple doses to assess safety and activity. The treatment continues for each participant until they either experience disease progression or choose to stop. Throughout the study, participants will undergo safety assessments focusing on treatment-emergent adverse events using standardized criteria. Researchers will monitor participants closely during treatment and through study completion, which includes a 28-day dose-limiting toxicity period. Participants will also provide tumor tissue samples before and possibly during treatment to help evaluate the therapy's effects. The total duration depends on individual treatment response and continuation until progression or withdrawal.
CONDITIONS
Brief 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 specified types including breast, NSCLC, cervical, CRPC, pancreatic, head-and-neck, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic
- Relapsed or refractory disease after at least 2 prior lines of therapy with no standard care options available
- Radiographically measurable disease
- ECOG performance status 0-1
- Life expectancy of at least 3 months as judged by the Investigator
- Adequate bone marrow, kidney, and liver function
- Completed tapering from high-dose systemic corticosteroids for at least 2 weeks; low-dose corticosteroids (≤ 25 mg prednisone daily) allowed with approval
- Willing to provide archival tumor tissue or undergo baseline biopsy
- Willing to undergo on-treatment biopsy if feasible and not contraindicated
You will not qualify if you...
- Major surgery within 28 days before Day 1
- Incomplete washout from systemic therapy or investigational agents before Cycle 1 Day 1
- Chemotherapy or anticancer therapies within 4 weeks or 5 half-lives, whichever is shorter
- Antibody-based anticancer therapy within 4 weeks
- Radiation therapy within 21 days before Cycle 1 Day 1 (palliative radiation may be allowed)
- Untreated or symptomatic brain metastases requiring steroids or anticonvulsants
- Active Grade ≥ 2 anorexia, nausea, vomiting, or intestinal obstruction
- Another malignancy except certain treated skin cancers or in situ diseases with no evidence for ≥ 1 year
- Significant uncontrolled diseases impacting study compliance
- Recent CNS diseases like stroke or epilepsy unless stable for 6 months
- QTcF > 480 msec or risk factors for Torsades de Pointes
- Uncontrolled cardiovascular disease or abnormal ECG deemed clinically significant
- Prior solid organ transplantation
- Known HIV, HBV, or HCV infection unless meeting specific controlled criteria
- Active infections requiring systemic treatment within 2 weeks prior to Cycle 1 Day 1
- Active interstitial pneumonitis within 6 months
- Other medical or psychiatric conditions affecting study interpretation or completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or withdrawal
Participants receive DR-0202 every 2 weeks until disease progression or withdrawal from the trial.
Biweekly visits for treatment administration
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
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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