Apply to Trial

Compensation: Varies

Number of Visits: 2

796 Participants Needed

DB-1303 for Solid Cancers

Recruiting at 100 trial locations

Overseen ByBritney Winterberger

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: DualityBio Inc.

Disqualifiers: Heart failure, Myocardial infarction, Lung diseases, others

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

Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment called DB-1303 (also known as BNT323) for individuals with advanced solid tumors that test positive for HER2, a protein that can affect cancer growth. Participants will receive different doses to determine the best and safest amount. The trial seeks individuals with a HER2-positive tumor that has not responded well to standard treatments or for which no standard treatment is available. 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that DB-1303/BNT323 is likely to be safe for humans?

Research shows that DB-1303/BNT323 has been well-tolerated by patients with advanced solid tumors. Studies indicate that the treatment's safety profile is manageable, with side effects usually mild and controllable. Patients in previous trials reported positive results, as the treatment showed potential benefits against tumors. Overall, evidence suggests that DB-1303/BNT323 is generally safe for humans, with no major safety concerns identified so far.¹ ² ³ ⁴ ⁵

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

Researchers are excited about DB-1303 because it targets solid cancers in a unique way. Unlike traditional chemotherapy, which often attacks both healthy and cancerous cells, DB-1303 is designed to specifically target cancer cells, potentially reducing side effects. This treatment involves an innovative approach: it combines DB-1303 with BNT323, aiming to enhance the therapeutic effects and improve patient outcomes. Additionally, the diverse dosing levels and expansion phases allow flexibility in finding the optimal balance between effectiveness and safety, setting it apart from current standard treatments.

What evidence suggests that this trial's treatment DB-1303 could be effective for solid cancers?

Research has shown that DB-1303, administered at different dose levels in this trial, yields promising results for treating advanced solid tumors with the HER2 protein, often linked to cancer growth. Studies have found that DB-1303 can shrink tumors and is well-tolerated, even in patients who have tried many other treatments. Early findings suggest that the drug works against various types of cancer, not just those with high HER2 levels. The FDA has granted this treatment a Breakthrough Therapy Designation, highlighting its potential to significantly help patients. These results make DB-1303 a hopeful option for those with advanced cancers.¹ ² ³ ⁶ ⁷

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that are HER2-positive or express HER2, and have not responded to standard treatments or have no standard options left. Participants must be relatively healthy (ECOG 0-1), have a life expectancy of at least 3 months, a functioning heart (LVEF ≥ 50%), and adequate organ function.

Inclusion Criteria

Provide signed informed consent

My cancer is HER2-positive or expresses HER2, is advanced, and doesn't respond to standard treatments.

I can provide a HER2 status report or a sample of my tumor.

See 5 more

Exclusion Criteria

I have a history of serious heart failure or heart rhythm problems needing treatment.

I haven't had a heart attack or unstable chest pain in the last 6 months.

I don't have lasting side effects from cancer treatment worse than mild.

See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of DB-1303/BNT323 to identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

21 days per cycle

1 visit per cycle (in-person)

Dose Expansion

Participants receive the RP2D to confirm safety, tolerability, and explore efficacy in selected malignant solid tumors

21 days per cycle

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

35 days post-treatment

What Are the Treatments Tested in This Trial?

Interventions

DB-1303

Trial Overview

The study tests DB-1303's safety and effectiveness in different doses for those with specific types of advanced cancer. It includes other drugs like Itraconazole, Pertuzumab Injection, Ritonavir as part of the treatment regimen in a Phase 1/2a setting.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Group I: DB-1303/BNT323 Dose Level 7Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W

Group II: DB-1303/BNT323 Dose Level 6Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W

Group III: DB-1303/BNT323 Dose Level 5Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W

Group IV: DB-1303/BNT323 Dose Level 4Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W

Group V: DB-1303/BNT323 Dose Level 3Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W

Group VI: DB-1303/BNT323 Dose Level 2Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W

Group VII: DB-1303/BNT323 Dose Level 1Experimental Treatment1 Intervention

Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W

Group VIII: DB-1303/BNT323 Dose Expansion 9Experimental Treatment1 Intervention

Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W

Group IX: DB-1303/BNT323 Dose Expansion 8Experimental Treatment1 Intervention