RightFit
RecruitingPhase 1 / Phase 2

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

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests the safety of DB-1303/BNT323 at different doses and how well people can tolerate it. It is for people with advanced solid cancers, usually with a protein called HER2, whose standard treatments have not worked, cannot be tolerated, or are not available.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a solid cancer confirmed by lab testing that is advanced, cannot be removed by surgery, has come back, or has spread. Standard treatment has not worked, cannot be tolerated, or is not available.
  • The cancer must have HER2, except in group 2h, which requires cancer with no HER2.
  • Have at least one tumor that can be measured.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have a heart that pumps out at least 50% of its blood with each beat, and organs that work well enough.
  • Provide past HER2 test results or a tumor sample, or have a new biopsy—a procedure to take a tumor sample—for HER2 testing.
  • Sign a consent form and be expected to live at least 3 months.
  • For Part 2, Group 9: Have advanced cancer of the uterus lining, including certain related types. It must have worsened during or after at least one treatment, including platinum chemotherapy and an immune checkpoint drug. Have had no more than 3 treatment courses for advanced disease; hormone treatment does not count.

Who can't join

  • Have a history of heart failure with symptoms or a serious abnormal heartbeat that needs treatment.
  • Had a heart attack or unstable chest pain within 6 months before starting, or have a heart rhythm test result called QTcF above 450 milliseconds for males or 470 for females.
  • Have a history of serious lung disease.
  • Have an uncontrolled infection needing medicine through a vein, HIV with an AIDS-related illness, or active viral hepatitis—a liver infection.
  • Have cancer that has spread to the brain and is currently active.
  • Have side effects from past cancer treatment that have not returned to mild levels or your usual baseline.
  • Have a known allergy to the study drug or any of its ingredients.
  • For Part 2 only: Have had more than one separate cancer within 3 years. Exceptions include fully removed non-melanoma skin cancer, cancer that stayed where it started and was treated to cure it, other solid cancers treated to cure them, or cancer in the other breast.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 ≥ 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 ≥ 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 advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line. Exclusion Criteria: * History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment. * History of myocardial infarction or unstable angina within 6 months before Day 1. * Average QTcF \> 450 ms in males and \> 470 ms in females * History of clinically significant lung diseases * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. * HIV infection with AIDS defining illness or active viral hepatitis. * Clinically active brain metastases * Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline. * A known hypersensitivity to either the drug substances or inactive ingredients in the drug product. * Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

Study sites (35)

CA

DC

FL

GA

HI

IL

LA

MA

MD

MI

MO

NC

NV

NY

OH

OK

PA

TN

TX

VA

WA