Back to search results

A Study of DR-0202 for Advanced Cancers

This study is testing a drug called DR-0202, which is a bispecific antibody. It's for people with locally advanced or metastatic (spread to other parts of the body), relapsed (came back after treatment), or refractory (didn't respond to treatment) carcinomas. This includes specific types of breast cancer (Triple Negative, HER2-negative), non-small cell lung cancer, cervical cancer, and castrate-resistant prostate cancer, among others. To join, you must have tried at least two previous treatments and have no standard treatment options left. The main goal is to see how safe DR-0202 is and what side effects it might cause. The study plans to enroll 96 participants. The current recruitment status is unclear.

Study design
This is a Phase 1a/1b, multicenter, open-label study. It will involve a dose escalation and expansion to evaluate DR-0202 in approximately 96 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured during DR-0202 treatment through study completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06999187

A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

Recruiting
PHASE1Ages 18+InterventionalTreatment
Dren Bio
~96 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:DR-0202

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over 28-day DLT Period and Treatment Duration / Study Completion

Conditions

Triple Negative Breast Cancer
HER2-negative Breast Cancer
Non Small Cell Lung Cancer
Cervical Cancer
Castrate Resistant Prostate Cancer
Pancreatic Ductal Adenocarcinoma
Head-and-neck Squamous Cell Carcinoma
Endometrial Cancer
Ovarian Cancer
Gastric Cancer
Gastroesophageal-junction Cancer
Urothelial Carcinoma

Explore related trials

Breast CarcinomaCervical CarcinomaEndometrial CarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic Ductal AdenocarcinomaProstate CarcinomaSolid NeoplasmUrothelial Carcinoma

Where it's being run

10 sites across 7 states
Texas3
Florida2
Colorado1
North Carolina1
Oklahoma1
South Carolina1
Virginia1

Study leadership

  • Wan Jen Hong, MD · STUDY_DIRECTOR · Dren Bio

Who to contact

Dren Bio Central Contact
[email protected]
415-737-5277
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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:
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):
Active infection requiring systemic treatment, defined as requiring IV antimicrobial, antifungal, or antiviral agents within 2 weeks prior to C1D1. Prophylactic antimicrobial treatment is allowed. Infections eligible per Exclusion Criterion 16 may be enrolled.
Active clinical interstitial pneumonitis (e.g., shortness of breath, requirement of supplemental oxygen, dry cough) or as confirmed by means of diagnostic imaging within 6 months prior to C1D1.
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

What this trial measures

  • 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)28-day DLT Period and Treatment Duration / Study Completion

    * 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)