ClinicalTrials.gg
RecruitingNCT05150691Updated Aug 27, 2026

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

A Phase 1/2 interventional study of DB-1303/BNT323 and Pertuzumab Injection in HER2-positive Advanced Solid Tumor, sponsored by DualityBio Inc.. Recruiting at 102 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by DualityBio Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
796
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.

02

Conditions studied

  • HER2-positive Advanced Solid Tumor

Keywords

  • HER2
  • HER2-positive
  • HER2-positive Breast Cancer
  • HER2-positive Gastric Cancer
  • HER2-positive Endometrial Cancer
  • HER2-positive Biliary Tract Cancer
  • HER2-positive Advanced Solid Tumor
  • HER2 low
  • HER2 high
  • metastatic cancer
  • HER2-positive GEJ
  • Uterine serous papillary carcinoma
  • USPC
  • recurrent cancer
  • carcinoma
  • neoplasms
  • breast neoplasms
  • gastrointestinal neoplasms
  • endometrial neoplasms
  • biliary tract neoplasms
  • Antineoplastic Agents, Biological
  • stomach cancer
  • bile duct cancer
  • Cholangiocarcinoma
  • liver cancer
  • liver neoplasms
  • NSCLC
  • Non-Small Cell Lung Cancer
  • NSCLC HER2 mutation
  • HER2 Low Breast Cancer
03

In context

Neoplasm Metastasis

4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.

This study's planned enrollment of 796 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

DualityBio Inc. is the lead sponsor of 12 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has a documented -positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or malignant solid tumor that is to or intolerable with standard treatment, or for which no standard treatment is available.
  • At least 1 (per 1.1)
  • Provide signed
  • performance status (PS) of 0-1.
  • ≥ 50% by ECHO or MUGA
  • Adequate organ functions
  • Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor for HER2 testing.
  • 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 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

Exclusion Criteria:

  • History of symptomatic CHF ( [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  • History of myocardial infarction or unstable angina within 6 months before Day 1.
  • Average > 450 ms in males and > 470 ms in females
  • History of lung diseases
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • infection with AIDS defining illness or active viral hepatitis.
  • Clinically active
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to version 5.0, Grade ≤ 1 or baseline.
  • A known to either the drug substances or inactive ingredients in the drug product.
  • Part 2 (expansion) Only:Multiple primary within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
796 participants (estimated)

Study arms

  • Experimental
    DB-1303/BNT323 Dose Level 1

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Level 2

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Level 3

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Level 4

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Level 5

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 1

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 2

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 3

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 4

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 5

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Level 6

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Level 7

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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 6

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 7

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 8

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 9

    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

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 10

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential

    Biological: DB-1303/BNT323 · Drug: Ritonavir · Drug: Itraconazole

  • Experimental
    DB-1303/BNT323 Dose Expansion 11

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 12

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323 · Drug: Pertuzumab Injection

  • Experimental
    DB-1303/BNT323 Dose Expansion 13

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 14

    China Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 15

    China Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 16

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

  • Experimental
    DB-1303/BNT323 Dose Expansion 17

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Biological: DB-1303/BNT323

Interventions

06

What researchers measure

Primary outcomes

  1. Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.

    Percentage of participants in Part 1 with DLTs

    Time frame: up to 21 days after C1D1

  2. Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0

    Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).

    Time frame: Up to Safety Follow-Up visit, approximately 35 days post-treatment

  3. Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

    Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  4. Phase 1: Maximum Tolerated Dose (MTD) of DB-1303

    MTD on the data collected during Part 1

    Time frame: Up to Safety Follow-Up visit, approximately 35 days post-treatment

  5. Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303

    RP2D of DB-1303 based on the data collected during Part 1

    Time frame: Up to Safety Follow-Up visit, approximately 35 days post-treatment

  6. Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0

    Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  7. Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

    Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  8. Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.

    The percentage of subjects who had a best response of CR or PR, for Part 2 only which was maintained ≥4 weeks.

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  9. Phase 2 (Dose Expansion 10 only): To evaluate the effect of ritonavir on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors

    Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Ritonavir)

    Time frame: up to safety follow-up visit, approx. 35 days post-treatment

  10. Phase 2 (Dose Expansion 10 only): To evaluate the effect of itraconazole on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors.

    Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Itraconazole)

    Time frame: up to safety follow-up visit, approx. 35 days post-treatment

Secondary outcomes

  1. Phase 1 & Phase 2: Pharmacokinetic-AUC

    Area under the concentration-time curve from time 0 to infinity of DB-1303

    Time frame: Up to safety follow up visit, approx. 35 days post-treatment

  2. Phase 1 & Phase 2: Pharmacokinetic-Cmax

    Maximum observed plasma concentration (Cmax) of DB-1303

    Time frame: Up to safety follow up visit, approx. 35 days post-treatment

  3. Phase 1 & Phase 2: Pharmacokinetic-Tmax

    Time to Cmax of DB-1303

    Time frame: Up to safety follow up visit, approx. 35 days post-treatment

  4. Phase 1 & Phase 2: Pharmacokinetic-T1/2

    Terminal elimination half-life

    Time frame: Up to safety follow up visit, approx. 35 days post-treatment

  5. Phase 1 & Phase 2: Pharmacokinetic-Ctrough

    Trough concentration of DB-1303

    Time frame: Up to safety follow up visit, approx. 35 days post-treatment

  6. Phase 1 & Phase 2: Pharmacodynamics-ADA

    Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.

    Time frame: Up to safety follow up visit, approx. 35 days post-treatment

  7. Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1

    Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  8. Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1

    The duration of time from date of first CR or PR to date of progressive disease or death due to any cause, whichever comes first using RECIST V1.1

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  9. Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1

    The duration of time when receiving the first dose of study drug to the first date that is evaluated as either CR or PR using RECIST V1.1

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  10. Phase 2: Time on Therapy

    The duration of time from participant receiving first dose of study drug to the last dose + 21 days

    Time frame: Up to 21 days after the participant's last dose

  11. Phase 2: Percent change in target lesions as assessed by RECIST 1.1

    The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  12. Phase 1 and 2 Cohort b only: Progression-Free Survival

    Time from subject receiving the first dose to disease progression or death by any cause

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  13. Phase 1 and 2 Cohort b only: Overall Survival

    Time from subject receiving the first dose to death by any cause

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  14. Phase I: Percentage of Objective Response Rate (ORR) as assessed by investigator based on RECIST 1.1

    The percentage of subjects who had a best response of CR or PR

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  15. Phase 2 Cohort b Only: Percentage of ORR as assessed by IRC and as assessed by investigator based on RECIST 1.1 for HER2-expressing subjects and in subjects with prior ICI treatment

    The percentage of subjects who had a best response of CR or PR, for Cohort 2b only

    Time frame: Up to follow-up period, approximately 1 year post-treatment

  16. To evaluate the safety of DB-1303 with/without ritonavir or itraconazole

    Percentage of Participants with Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAE), TEAEs \>/= G3, or TEAEs leading to dose reduction, interruption or discontinuation, Adverse Events of Special Interest, (AESIs), abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).

    Time frame: Up to follow-up period, approximately 1 year post-treatment

07

Study locations

46 of 102 sites recruiting
  • Helios Clinical Research
    Cerritos, California 90703, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • California Research Institute
    Los Angeles, California 90027, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sharp Memorial Hospital
    San Diego, California 92123, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Washington Cancer Institute at MedStar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Advanced Research LLC
    Coral Springs, Florida 33065, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Oncology Institute of Hope and Innovation
    Lakeland, Florida 33812, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • D&H Cancer Research Center LLC
    Margate, Florida 33063, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • HCA Mercy Hospital
    Miami, Florida 33133, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • BRCR Medical Center Inc.
    Plantation, Florida 33322, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • BRCR Medical Center Inc.
    Tamarac, Florida 33321, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Southeastern Regional Medical Center, LLC
    Newnan, Georgia 30265, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kapi'olani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of Chicago
    Chicago, Illinois 60637, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Women's Cancer Care
    Covington, Louisiana 70433, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Holy Cross Hospital
    Silver Spring, Maryland 20910, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Massachusetts General Hospital
    Boston, Massachusetts 02214, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Profound Research LLC/Michigan Hematology & Oncology Consultants
    Dearborn, Michigan 48126, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • David C. Pratt Cancer Center
    St Louis, Missouri 63141, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Women's Cancer Center of Nevada
    Las Vegas, Nevada 89106, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Northwell Health
    Lake Success, New York 11042, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
    New York, New York 10016, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists
    Shirley, New York 11967, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Regional Medical Oncology Center
    Wilson, North Carolina 27893, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Gabrail Cancer Center
    Canton, Ohio 44718, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of Oklahoma
    Oklahoma City, Oklahoma 73104, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Rittenhouse Hematology Oncology
    Philadelphia, Pennsylvania 19107, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • AHN West Penn Hospital
    Pittsburgh, Pennsylvania 15224, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Tennessee Oncology
    Nashville, Tennessee 37203, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Clinical Trial Network
    Houston, Texas 77074, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Oncology and Hematology of South Texas, PA
    Laredo, Texas 78041, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • NEXT Virginia
    Fairfax, Virginia 22031, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Swedish Cancer Institute
    Seattle, Washington 98104, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Scientia Clinical Research LTD
    Randwick, New South Wales 2031, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Macquarie Clinical Trials Unit
    Sydney, New South Wales 2109, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Integrated Clinical Oncology Network Pty Ltd (Icon)
    South Brisbane, Queensland 4101, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Monash Health
    Melbourne, Victoria 3168, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The first affiliated hospital of Bengbu medical college
    Bengbu, Anhui, China
    Recruiting
  • Anhui provincial hospital
    Hefei, Anhui, China
    Recruiting
  • The Second Hospital of Anhui Medical University
    Hefei, Anhui, China
    Recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing Municipality, China
    Recruiting
  • Cancer Hospital Chinese Academy of Medical Science
    Beijing, Beijing Municipality, China
    Recruiting
  • The First Hospital of Jilin University
    Hongcun, Changchun, China
    Recruiting
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing Municipality, China
    Recruiting
  • The First affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality, China
    Recruiting
  • The First affiliated hospital of Xiamen University
    Xiamen, Fujian, China
    Recruiting
  • Gansu Provincial Maternity and Child-care Hospital
    Lanzhou, Gansu, China
    Recruiting
  • Huizhou First Hospital
    Guangzhou, Guangdong, China
    Recruiting
  • Sun Yat-Sen Memorial Hospital of Zhongshan University
    Guangzhou, Guangdong, China
    Recruiting
  • The First affiliated hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting
  • Cancer Hospital of Guangxi Medical University
    Nanning, Guangxi, China
    Recruiting
  • The First people's hospital of Yulin
    Yulin, Guangxi, China
    Recruiting
  • Affiliated Hospital of Hebei University
    Baoding, Hebei, China
    Recruiting
  • Henan cancer Hospital
    Zhengzhou, Hehan, China
    Recruiting
  • Anyang Tumor Hospital
    Anyang, Henan, China
    Recruiting
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
    Recruiting
  • Union hospital Tongji Medical college Huazhong university of science and technology
    Wuhan, Hubei, China
    Recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan, China
    Recruiting
  • Hunan People's Provincial Hospital
    Changsha, Hunan, China
    Recruiting
  • Xiangya Hospital Central South University
    Changsha, Hunan, China
    Recruiting
  • Changzhou Tumor Hospital
    Changzhou, Jiangsu, China
    Withdrawn

    Not enrolling at this site — choose another above.

  • Affiliated Hospital of Jiangnan University
    Wuxi, Jiangsu, China
    Recruiting
  • The Affiliated Hospital of Xuzhou Medical College
    Xuzhou, Jiangsu, China
    Recruiting
  • Xuzhou Cancer Hospital
    Xuzhou, Jiangsu, China
    Withdrawn

    Not enrolling at this site — choose another above.

  • Jiangxi maternal and child health hospital
    Nanchang, Jiangxi, China
    Recruiting
  • The Third Hospital of Nanchang
    Nanchang, Jiangxi, China
    Recruiting
  • Jilin Cancer Hospital
    Changchun, Jilin, China
    Recruiting
  • Liaoning cancer hospital & Institute
    Shenyang, Liaoning, China
    Recruiting
  • The First Hospital of China Medical University
    Shenyang, Liaoning, China
    Recruiting
  • The First Affiliated Hospital Of Xi'an Jiaotong University
    Xi'an, Shaanxi, China
    Recruiting
  • Central hospital affiliated to Shandong first medical university
    Jinan, Shandong, China
    Recruiting
  • Jinan Central Hospital
    Jinan, Shandong, China
    Recruiting
  • Shandong Cancer hospital & institute
    Jinan, Shandong, China
    Recruiting
  • Affiliated hospital of Jining medical university
    Jining, Shandong, China
    Recruiting
  • Linyi Tumor Hospital
    Liaocheng, Shandong, China
    Recruiting
  • Zibo Central hospital
    Zibo, Shandong, China
    Recruiting
  • Yantai Yuhuangding Hospital
    Yantai, Shangdong, China
    Withdrawn

    Not enrolling at this site — choose another above.

  • Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Shanghai Tenth people's Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
  • The Obstetrics & Gynecology Hospital Affiliated to Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Tianjin Medical university cancer institute & hospital
    Tianjin, Tianjin Municipality, China
    Recruiting
  • Yunnan Provincial Cancer Hospital
    Kunming, Yunnan, China
    Recruiting
  • 1st affliated hospital of Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting
  • The second affiliated hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting
  • Women's hospital school of medicine Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang, China
    Recruiting
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang, China
    Withdrawn

    Not enrolling at this site — choose another above.

  • BRCR Global Puerto Rico LLC.
    Mayagüez, 00682, Puerto Rico
    Withdrawn

    Not enrolling at this site — choose another above.

  • Seoul National University Bundang Hospital
    Gyeonggi-do, Bundang-gu 13620, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Samsung Medical Center
    Seoul, Gangnam-gu 06351, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • National Cancer Center
    Gyeonggi-do, Ilsandong-gu 10408, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Severance Hospital
    Seoul, Seodaemun-gu 03722, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Asan Medical Center
    Seoul, Songpa-gu 05505, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Taipei Veterans General Hospital
    Taipei, Beitou District 11217, Taiwan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Changhua Christian Hospital
    Changhua, Changhua County 50006, Taiwan
    Active, not recruiting

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  • Taipei Medical University Hospital
    Taipei, Xinyi District 110301, Taiwan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Taipei Medical University-Shuang Ho Hospital
    Taipei, Zhonghe District 235041, Taiwan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Mackay Memorial Hospital-Taipei
    Taipei, Zhongshan District 10449, Taiwan
    Active, not recruiting

    Not enrolling at this site — choose another above.

Showing the first 100 of 102 sites across 6 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05150691
Lead sponsor
DualityBio Inc.
Collaborators
BioNTech SE
Responsible party
Sponsor
First posted
Dec 9, 2021
Start date
Jan 31, 2022
Primary completion
Aug 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Britney Winterberger
Contact
britney.winterberger@tigermedgrp.com
+1-513-403-8568

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Trastuzumab pamirtecan

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