96 Participants Needed

DR-0202 for Advanced Cancer

Recruiting at 9 trial locations
DB
Overseen ByDren Bio Central Contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and activity of a new treatment, DR-0202, for advanced cancers that have returned or do not respond to other treatments. Participants will receive varying doses of DR-0202 every two weeks to determine the most effective dose. The trial seeks individuals with specific types of advanced cancer, such as breast, lung, or ovarian cancer, who have tried at least two other treatments without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications before joining the trial. There is a required 'washout period' (time without taking certain medications) for systemic chemotherapy and anticancer therapies, which is 4 weeks or 5 half-lives of the drug, whichever is shorter. However, low-dose corticosteroids and some other medications are allowed, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that DR-0202 is likely to be safe for humans?

Research has shown that DR-0202 is a new treatment being tested for safety in people with advanced cancer. This phase 1 trial aims to determine if DR-0202 is safe for humans and to find the right dose.

Specific data on how patients handle DR-0202 is not yet available, but early trials like this typically focus on identifying any side effects. As this is the first step in human testing, researchers are still gathering safety information. The treatment might have side effects, but researchers closely monitor participants to ensure their safety.

If a treatment has been used safely in other trials or is approved for other conditions, it can provide some confidence in its safety. However, DR-0202 remains under study, so new information will emerge as the study progresses.12345

Why do researchers think this study treatment might be promising for cancer?

DR-0202 is unique because it offers a range of dosage levels, allowing researchers to fine-tune its effectiveness and safety for advanced cancer patients. Unlike traditional chemotherapy, which often targets all rapidly dividing cells, DR-0202 is designed to be more selective, potentially reducing side effects. Researchers are excited about this treatment because it may provide a more personalized approach to cancer therapy, giving patients tailored dosages to maximize benefits while minimizing risks.

What evidence suggests that this trial's treatment, DR-0202, could be effective for advanced cancer?

Research has shown that DR-0202 is a new treatment called a bispecific antibody, which targets two different proteins simultaneously. This method may enhance the immune system's ability to attack cancer cells. In some lab studies, DR-0202 slowed the growth of certain cancer cells. Although human studies provide limited information, these early results suggest that DR-0202 might help treat advanced cancers unresponsive to other treatments. More research is needed to confirm these initial findings. Participants in this trial will receive different dosages of DR-0202 to evaluate its effectiveness and safety.12567

Who Is on the Research Team?

WJ

Wan Jen Hong, MD

Principal Investigator

Dren Bio

Are You a Good Fit for This Trial?

This trial is for adults with various advanced or metastatic cancers that have come back or didn't respond to treatment. Specific types include breast, endometrial, bladder, gastroesophageal junction, thyroid, lung (non-small cell), squamous cell carcinoma of the head and neck region including throat cancer, cervical, ovarian, stomach, prostate and pancreatic cancers.

Inclusion Criteria

Willing to provide archival tumor tissue samples or agree to a baseline biopsy
Radiographically measurable disease
Life expectancy of ≥ 3 months
See 6 more

Exclusion Criteria

Abnormal ECG or myocardial infarction within 6 months prior to C1D1
Significant, uncontrolled concomitant disease
QT interval for heart rate using Fridericia's formula (QTcF) > 480 msec or history of additional risk factors for Torsades de Pointes
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation/Expansion

Participants receive varying doses of DR-0202 every 2 weeks until progression or withdrawal

Expected to be an average of 1 year
Bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DR-0202
Trial Overview The study tests DR-0202's safety and effectiveness in patients with certain carcinomas. It's a phase 1a/1b trial involving multiple centers where participants receive escalating doses of DR-0202 to find the right balance between safety and activity against cancer.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: DL8 of DR-0202Experimental Treatment1 Intervention
Group II: DL7 of DR-0202Experimental Treatment1 Intervention
Group III: DL6 of DR-0202Experimental Treatment1 Intervention
Group IV: DL5 of DR-0202Experimental Treatment1 Intervention
Group V: DL4 of DR-0202Experimental Treatment1 Intervention
Group VI: DL3 of DR-0202Experimental Treatment1 Intervention
Group VII: DL2 of DR-0202Experimental Treatment1 Intervention
Group VIII: DL1 of DR-0202Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dren Bio

Lead Sponsor

Trials
6
Recruited
280+

Citations

NCT06999187 | A Study of DR-0202 in Patients With ...Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+/HER2-/+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, ...
DR-0202 for Advanced CancerThis trial is for adults with various advanced or metastatic cancers that have come back or didn't respond to treatment. Specific types include breast, ...
A Study of DR-0202 in Patients With Locally Advanced or ...A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in ...
MTS Trials - BreastCancerTrials.orgPurpose: To study the safety, effects (good and bad), and anti-cancer activity of DR-0202, an experimental bispecific antibody. Who is this for?: People with ...
News / Dren BioThe platform's lead program, DR-0201 (now known as SAR448501), was acquired by Sanofi in May 2025. Its second platform candidate, DR-0202, advanced into ...
A Study of DR-0202 in Patients With Locally Advanced orThe goal is to see how safe this treatment is and how well it works for patients whose cancer has returned or hasn't responded to previous treatments. The trial ...
DR-0202 - Drug Targets, Indications, Patents... Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas. 100 Clinical Results associated with DR-0202.
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