Triple Negative Breast CancerPhase 1NCT06999187
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
A Phase 1 study testing DR-0202 in people with Triple Negative Breast Cancer and HER2-negative Breast Cancer, run by Dren Bio at 10 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, HER2-negative Breast Cancer, Non Small Cell Lung Cancer
- What is being tested?
- DR-0202
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Jun 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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):
- Participants who are HIV-positive with undetectable HIV RNA and at least 3 months on antiretroviral therapy.
- Participants with a positive serologic test for HBV (i.e., positive HBcAb and negative HBsAg) and have a negative PCR test.
- Participants who are HCV-positive who have completed at least 1 month of highly effective antiviral therapy and have a negative PCR test.
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Dren Investigational Site
Austin, Texas, 78758
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Dallas, Texas, 75230
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Denver, Colorado, 80218
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Fairfax, Virginia, 22031
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Greenville, South Carolina, 29605
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Huntersville, North Carolina, 28078
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Oklahoma City, Oklahoma, 73104
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Orlando, Florida, 32827
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
San Antonio, Texas, 78229
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
- Recruiting
Dren Investigational Site
Sarasota, Florida, 34232
Dren Bio Central Contact, 415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com
About this study
Official title: 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
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
- Triple Negative Breast Cancer, HER2-negative Breast Cancer, Non Small Cell Lung Cancer, Cervical Cancer, Castrate Resistant Prostate Cancer, Pancreatic Ductal Adenocarcinoma
- Being tested
- DR-0202
- Medical subject headings
- Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck, Endometrial Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR-0202Drug
DR-0202 is a bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| DL1 of DR-0202 | Experimental | Participants in this arm will receive DL1 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
| DL2 of DR-0202 | Experimental | Participants in this arm will receive DL2 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
| DL3 of DR-0202 | Experimental | Participants in this arm will receive DL3 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
| DL4 of DR-0202 | Experimental | Participants in this arm will receive DL4 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
| DL5 of DR-0202 | Experimental | Participants in this arm will receive DL5 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
| DL6 of DR-0202 | Experimental | Participants in this arm will receive DL6 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
| DL7 of DR-0202 | Experimental | Participants in this arm will receive DL7 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
| DL8 of DR-0202 | Experimental | Participants in this arm will receive DL8 milligrams of DR-0202 every 2 weeks until progression or withdrawal Receives: Drug: DR-0202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28-day DLT Period and Treatment Duration / Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start3 Jun 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dren Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wan Jen Hong, MD, Study director, Dren Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999187
- Sponsor's protocol ID
- DR-0202-ONC-001
- Status last verified
- Aug 2025
- First submitted
- 12 May 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06999187
- Acronym / sponsor ID
- DR-0202-ONC-001
- Conditions
- Triple Negative Breast Cancer, HER2-negative Breast Cancer, Non Small Cell Lung Cancer, Cervical Cancer, Castrate Resistant Prostate Cancer, Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Dren BioIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| DL1 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL1 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
| DL2 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL2 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
| DL3 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL3 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
| DL4 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL4 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
| DL5 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL5 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
| DL6 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL6 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
| DL7 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL7 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
| DL8 of DR-0202 | Experimental | Drug: DR-0202Participants in this arm will receive DL8 milligrams of DR-0202 every 2 weeks until progression or withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DR-0202DR-0202 is a bispecific antibody | Drug | DL1 of DR-0202, DL2 of DR-0202, DL3 of DR-0202, DL4 of DR-0202, DL5 of DR-0202, DL6 of DR-0202, DL7 of DR-0202, DL8 of DR-0202 |
Primary outcome
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
* 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wan Jen Hong, MD study director
Dren Bio
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DR-0202 in people with Triple Negative Breast Cancer and HER2-negative Breast Cancer, run by Dren Bio at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dren Bio Central Contact (415-737-5277, DR-0202-ONC-001_inquiries@drenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.