A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
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
1 other identifier
interventional
96
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2025
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 31, 2025
CompletedStudy Start
First participant enrolled
June 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 7, 2026
August 1, 2025
2.1 years
May 12, 2025
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
* Incidence, severity, and relationship of TEAEs (per CTCAE v5.0) through study completion (expected to be an average of 1 year) including but not limited to vital signs, clinical laboratory values (hematology, clinical chemistry, coagulation, urinalysis), 12-lead ECG * Occurrence of DLTs during Cycle 1 (28 days)
28-day DLT Period and Treatment Duration / Study Completion
Study Arms (8)
DL1 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL1 milligrams of DR-0202 every 2 weeks until progression or withdrawal
DL2 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL2 milligrams of DR-0202 every 2 weeks until progression or withdrawal
DL3 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL3 milligrams of DR-0202 every 2 weeks until progression or withdrawal
DL4 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL4 milligrams of DR-0202 every 2 weeks until progression or withdrawal
DL5 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL5 milligrams of DR-0202 every 2 weeks until progression or withdrawal
DL6 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL6 milligrams of DR-0202 every 2 weeks until progression or withdrawal
DL7 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL7 milligrams of DR-0202 every 2 weeks until progression or withdrawal
DL8 of DR-0202
EXPERIMENTALParticipants in this arm will receive DL8 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Interventions
DR-0202 is a bispecific antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Major surgery within 28 days prior to Day 1
- Have not had an appropriate washout period from systemic therapy, including investigational agents, prior to C1D1:
- Systemic chemotherapy and anticancer therapies within 4 weeks or 5 half-lives of the drug, whichever is shorter.
- Antibody-based anticancer therapy: ≥ 4 weeks. Note: Treatment with systemic corticosteroids ≤ 25 mg/day (prednisone or equivalent) and inhaled or topical steroids are allowed. For participants with CRPC, LHRH agents are allowed.
- Radiation therapy within 21 days prior to C1D1. Palliative radiation therapy may be allowed following discussion with Medical Monitor
- Brain metastases either untreated and symptomatic or requiring therapy with steroids or anticonvulsants to control associated symptoms. Brain metastases that have been treated and are no longer symptomatic are allowed if use of high-dose systemic corticosteroids (\> 25 mg/day of prednisone or equivalent) is stopped ≥ 12 weeks prior to C1D1.
- Active Grade ≥ 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
- Another malignancy (except for adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 1 year)
- Evidence of significant, uncontrolled concomitant disease that could affect compliance with study.
- Current or past history of CNS disease, such as stroke, epilepsy, central nervous system vasculitis or neurodegenerative disease (participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits may be eligible).
- QT interval for heart rate using Fridericia's formula (QTcF) \> 480 msec or history of additional risk factors for Torsades de Pointes
- Uncontrolled or significant cardiovascular disease
- History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion or myocardial infarction within 6 months prior to C1D1.
- Prior solid organ transplantation.
- Known infection with HIV, HBV, or HCV. The following participants may be enrolled in this study (the Sponsor reserves the right to restrict enrollment of these participants):
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dren Biolead
Study Sites (10)
Dren Investigational Site
Denver, Colorado, 80218, United States
Dren Investigational Site
Orlando, Florida, 32827, United States
Dren Investigational Site
Sarasota, Florida, 34232, United States
Dren Investigational Site
Huntersville, North Carolina, 28078, United States
Dren Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Dren Investigational Site
Greenville, South Carolina, 29605, United States
Dren Investigational Site
Austin, Texas, 78758, United States
Dren Investigational Site
Dallas, Texas, 75230, United States
Dren Investigational Site
San Antonio, Texas, 78229, United States
Dren Investigational Site
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wan Jen Hong, MD
Dren Bio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 31, 2025
Study Start
June 3, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 7, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share