BNT323/DB-1303 for Endometrial Cancer

(Fern-EC-01 Trial)

Recruiting at 28 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: BioNTech SE

Must not be taking: Immunosuppressants, Topoisomerase inhibitors

Disqualifiers: Small bowel obstruction, Uncontrolled illness, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Approximately 6 months

504 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BNT323/DB-1303, for women whose endometrial cancer has returned after treatment with immune checkpoint inhibitors. The study compares this treatment to standard chemotherapy options, such as doxorubicin or paclitaxel, to determine which helps patients live longer without cancer progression. It seeks women with endometrial cancer that has specific protein markers (HER2) and who have already undergone at least one round of platinum-based chemotherapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medication, you must stop it 14 days before the first dose, except for certain low-dose corticosteroids. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BNT323/DB-1303 was well-tolerated in earlier studies. In one study, patients with advanced endometrial cancer received this treatment, which worked well without causing serious side effects. Over 30 patients received doses of 7.0 mg/kg or 8.0 mg/kg, which proved safe. Another study involving individuals with advanced solid tumors also reported that the treatment was well-tolerated and showed positive results. These findings suggest that BNT323/DB-1303 is generally safe for humans. ^{1 2 3 4 5}

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

Most treatments for endometrial cancer, like doxorubicin and paclitaxel, focus on killing rapidly dividing cells through chemotherapy. But BNT323/DB-1303 stands out because it targets cancer cells more precisely. Researchers are excited about BNT323/DB-1303 because it is an antibody-drug conjugate, which means it can deliver a potent drug directly to cancer cells while minimizing damage to healthy cells. This targeted approach has the potential to be more effective and cause fewer side effects than traditional chemotherapy, making it a promising new option for patients.

What evidence suggests that BNT323/DB-1303 might be an effective treatment for endometrial cancer?

Research shows that BNT323/DB-1303 may help treat advanced endometrial cancer. The U.S. FDA has recognized its potential by granting it Breakthrough Therapy designation. In this trial, participants will receive either BNT323/DB-1303 or a single-agent chemotherapy (doxorubicin or paclitaxel) as chosen by the investigator. Earlier studies found that most patients continued using BNT323/DB-1303, suggesting it is generally well-tolerated and effective. Early results from these studies indicate that patients experienced longer periods without cancer progression compared to those on standard treatments. This suggests that BNT323/DB-1303 could be a promising option for people with this type of cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

This trial is for individuals with recurring uterine cancer who have previously been treated with immune checkpoint inhibitors. Participants must not have true sarcomas, should expect to live at least 12 weeks, and have measurable disease. They need an ECOG status of 0 or 1 and must have had platinum-based therapy before.

Inclusion Criteria

Measurable disease defined by RECIST 1.1

Life expectancy of ≥12 weeks at screening

I am a woman over 18 years old or meet the age requirement in my area.

Exclusion Criteria

Pregnant, breastfeeding, planning pregnancy during the study, or within 7 months after the last dose of study treatment

History of allergies, hypersensitivities, or intolerance to the study treatments or other monoclonal antibodies

I cannot take certain chemotherapies like paclitaxel and doxorubicin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Treatment

Participants receive BNT323/DB-1303 or investigator's choice of chemotherapy until disease progression or other discontinuation criteria are met

Approximately 6 months

Safety Follow-up

Participants are monitored for safety and adverse events after treatment

Up to 35 days after the last dose

Efficacy Follow-up

Participants are monitored for progression-free survival and overall survival

Up to approximately 32 months

Long-term Survival Follow-up

Participants are monitored for overall survival

Up to approximately 55 months

What Are the Treatments Tested in This Trial?

Interventions

• BNT323/DB-1303

Trial Overview The study compares the effectiveness of a new therapy called BNT323/DB-1303 against standard chemotherapy in patients with endometrial cancer that has come back after treatment. It focuses on how long patients live without their disease getting worse.

How Is the Trial Designed?

Group I: BNT323/DB-1303 Experimental Treatment 1 Intervention

Group II: Doxorubicin or paclitaxel Active Control 2 Interventions

Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

DualityBio Inc.

Industry Sponsor

Trials

12

Recruited

5,800+

Citations

1. investors.biontech.de investors.biontech.de/news-releases/news-release-details/biontech-and-dualitybio-receive-fda-breakthrough-therapy

BioNTech and DualityBio Receive FDA Breakthrough Therapy ... The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer.

2. onclive.com onclive.com/view/fda-grants-breakthrough-therapy-designation-to-bnt323-db-1303-in-endometrial-cancer

FDA Grants Breakthrough Therapy Designation to BNT323 ... The median duration of treatment was 2.6 months (range, 0.7-10.4), and 90.6% of patients remained on treatment at the data cutoff. Patients had ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06340568

NCT06340568 | A Clinical Study of the Anti-cancer Effects ... The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT05150691

A Phase 1/2a Study of DB-1303/BNT323 in Advanced ... Plan to present clinical data from an ongoing Phase 1/2a trial (NCT05150691) evaluating BNT323/DB-1303 in HER2-expressing advanced endometrial cancer in 2025.

5. investors.biontech.de investors.biontech.de/news-releases/news-release-details/biontech-and-dualitybio-announce-phase-3-trial-adc-candidate

BioNTech and DualityBio Announce Phase 3 Trial of ADC ... “The positive Phase 3 data and trastuzumab pamirtecan meeting the primary endpoint at the interim analysis indicate the potential of the BNT323/ ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.3023

Safety and efficacy of DB-1303 in patients with advanced/ ... DB-1303 was well tolerated with encouraging preliminary antitumor activity in heavily pretreated pts with advanced/metastatic solid tumors.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05150691

NCT05150691 | A Phase 1/2a Study of DB-1303/BNT323 ... This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors ...