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NCT05150691RECRUITINGIRB Ready

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Sponsored by DualityBio Inc.

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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 that express HER2.

Who Can Participate

Inclusion Criteria

Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
At least 1 measurable lesion (per RECIST 1.1)
Provide signed informed consent
ECOG performance status (PS) of 0-1.
LVEF โ‰ฅ 50% by ECHO or MUGA
Adequate organ functions
Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
Life expectancy of โ‰ฅ 3 months. Additional Inclusion Criteria for Part 2 Expansion Group 9: 1\. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

796 participants

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Gender

ALL

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Sponsor

DualityBio Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

ACTIVE_NOT_RECRUITING

Cerritos

California

Location available
View Cerritos location page
ACTIVE_NOT_RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
ACTIVE_NOT_RECRUITING

San Diego

California

Location available
View San Diego location page
ACTIVE_NOT_RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
ACTIVE_NOT_RECRUITING

Coral Springs

Florida

Location available
View Coral Springs location page
ACTIVE_NOT_RECRUITING

Lakeland

Florida

Location available
View Lakeland location page
ACTIVE_NOT_RECRUITING

Margate

Florida

Location available
View Margate location page
ACTIVE_NOT_RECRUITING

Miami

Florida

Location available
View Miami location page
ACTIVE_NOT_RECRUITING

Plantation

Florida

Location available
View Plantation location page

๐Ÿ“ And 26 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for HER2-positive Cancer Treatment in Cerritos?

Join others in California exploring innovative treatment options through clinical research

HER2-positive Cancer Treatment Options in Cerritos, California

If you're searching for HER2-positive Cancer treatment in Cerritos, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Cerritos, Los Angeles, San Diego and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with HER2-positive Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 796 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for HER2-positive Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for HER2-positive Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This HER2-positive Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05150691. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.