Clinical Trials List
Protocol NumberDB-1311-201
Active
2025-09-01 - 2030-06-30
Phase II
Recruiting7
ICD-10C7A.1
Malignant poorly differentiated neuroendocrine tumors
ICD-10C7A.8
Other malignant neuroendocrine tumors
ICD-10C7B.09
Secondary carcinoid tumors of other sites
ICD-10C7B.1
Secondary Merkel cell carcinoma
ICD-10C7B.8
Other secondary neuroendocrine tumors
ICD-10C80.0
Disseminated malignant neoplasm, unspecified
ICD-10D3A.8
Other benign neuroendocrine tumors
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9199.0
Disseminated malignant neoplasm
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
-
Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
-
Sponsor
DUALITYBIO INC. (Duality)
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- HSIN-CHEN LIN Division of Hematology & Oncology
- 謝合原 Division of Hematology & Oncology
- CHENG-HSIEN LIN Division of Hematology & Oncology
- YI-CHUN LIU Division of Hematology & Oncology
- Cheng-Lun Lai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 柯萬盛 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳宗哲 Division of Hematology & Oncology
- Ying-Chun Shen Division of Hematology & Oncology
- JIN-YUAN SHIH Division of Hematology & Oncology
- 許嘉林 Division of Hematology & Oncology
- 楊景堯 Division of Hematology & Oncology
- 蔡子修 Division of Hematology & Oncology
- 吳尚俊 Division of Hematology & Oncology
- YEN-TING LIN Division of Hematology & Oncology
- Chih-Hung Hsu Division of Hematology & Oncology
- Chiun Hsu Division of Hematology & Oncology
- 廖唯昱 Division of Hematology & Oncology
- 呂理駿 Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of Hematology & Oncology
- Jih-Hsiang Lee Division of Hematology & Oncology
- YU-YUN SHAO Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- TSUNG-HAO LIU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林昶廷 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- 蔡宗翰 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 林偉哲 Division of Hematology & Oncology
- 黃泰霖 Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 黃詩喻 Division of Hematology & Oncology
- 李易濰 Division of Hematology & Oncology
- 郭明濬 Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
- San-Chi Chen Division of Hematology & Oncology
- 周昱百 Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
- 林泰祺 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Hong Cheng
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced/Metastatic Solid Tumors
Objectives
To determine the RP2D of DB-1311 in combination with BNT327 by assessing the safety and tolerability in targeted participant populations.
To determine the RP2D of DB-1311 in combination with DB-1305 by assessing the safety and tolerability in targeted participant populations.
Test Drug
injection
Condensed Powder
Condensed Powder
Active Ingredient
DB-1311
BNT327
DB-1305
BNT327
DB-1305
Dosage Form
149
246
149
246
149
Dosage
--
Endpoints
Number of participants with Dose
Limiting Toxicities (DLTs)
Treatment-emergent adverse events
(TEAEs) and treatment-emergent
serious AE (TESAEs)
Limiting Toxicities (DLTs)
Treatment-emergent adverse events
(TEAEs) and treatment-emergent
serious AE (TESAEs)
Inclution Criteria
1. Adults aged ≥ 18 years or acceptable age according to local regulations at the time
of voluntarily signing informed consent.
2. At least one measurable lesion as assessed by the Investigator according to RECIST
v1.1 criteria.
3. Has a life expectancy of ≥ 3 months.
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
1 (see Section 8.4.3 for details).
. Has adequate organ function within 7 days prior to enrollment/randomization, defined
as below
6. Has adequate treatment washout period prior to the first dose of trial treatment,
defined as table below.
of voluntarily signing informed consent.
2. At least one measurable lesion as assessed by the Investigator according to RECIST
v1.1 criteria.
3. Has a life expectancy of ≥ 3 months.
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
1 (see Section 8.4.3 for details).
. Has adequate organ function within 7 days prior to enrollment/randomization, defined
as below
6. Has adequate treatment washout period prior to the first dose of trial treatment,
defined as table below.
Exclusion Criteria
Unless otherwise specified, the exclusion criteria are common to both part 1 and part 2.
Participants who meet any of the following criteria will be excluded from the trial:
1. Prior treatment with B7H3 targeted therapy.
2. Prior treatment with antibody-drug conjugate with topoisomerase inhibitor (e.g.,
trastuzumab deruxtecan).
3. Is a candidate to locoregional treatment (including surgical resection, stereotactic
radiation therapy or tumor ablation) with potential to induce complete or near
complete response and prolonged tumor control (sometimes described as “radical”
intent), per investigator’s assessment.
4. Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the
investigator, contra-indicates trial participation, limits compliance with trial procedures
or substantially increases the risk of incurring AEs, including:
a) Bleeding diathesis or active hemorrhage,
b) Active infection,
c) Child-Pugh class B or C cirrhosis,
d) Pulmonary disease with significant impact on lung function,
e) Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior
vena cava syndrome, carcinoid syndrome that is unstable and with available
alternative therapies),
f)
Psychiatric or abuse condition.
5.
Has uncontrolled or significant cardiovascular disease including any of the following:
a)
Medical history of unstable angina, acute coronary syndrome, cerebral vascular accident or other Grade ≥3 cardiovascular events, within 6 months before randomization/enrollment or symptomatic chronic heart failure (New York Heart Association Class II to IV, see Section 12.4.2). Participants with troponin levels above ULN at screening and without any myocardial infarction related symptoms should have a cardiologic consultation before randomization/enrollment to rule out myocardial infarction.
b)
Central or symptomatic peripheral pulmonary embolism within 3 months prior to randomization/enrollment. Participants with deep venous thrombosis and incidentally diagnosed peripheral pulmonary embolism are eligible if on a stable antithrombotic regimen.
c)
Uncontrolled hypertension (defined as systolic blood pressure [BP] ≥160 mm Hg or diastolic BP ≥100 mm Hg) maintained over time and despite antihypertensive treatment, or participants with a history of hypertensive crisis or hypertensive encephalopathy.
d)
Uncontrolled and/or clinically important cardiac arrhythmias.
e)
Corrected QTcF prolongation to >470 ms based on average of screening 12 lead ECG in triplicate.
f)
Have LVEF <50% by either ECHO or MUGA within 28 days before randomization/enrollment.
g)
Poorly controlled diabetes (fasting blood glucose ≥13.3 mmol/L [240 mg/dL]).
6.
Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.
7.
Has a history of (non-infectious) ILD/pneumonitis (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
8.
Has a history of underlying pulmonary disorder including, but not limited to, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
9.
Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
10.
Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy (defined as 2 brain images, same imaging modality, both of which are obtained after treatment to the brain metastases; these imaging scans should be obtained at least 4 weeks apart and show no evidence of intracranial progression), and are on stable or decreasing doses ofcorticosteroids equivalent to ≤10 mg/day prednisone are eligible for trial entry.
Participants with untreated, asymptomatic brain metastasis for whom local therapy is
not indicated per standard of care may be eligible if neurologically stable and (if
deemed necessary by the investigator) after discussion with the sponsor’s medical
monitor. Participants at imminent risk for spinal cord compression or leptomeningeal
disease are not eligible.
11. Has a known history or a positive test at screening of any of the following:
a) HIV-1 or HIV-2 infection.
Note: For dose expansion Arms of part 2 only, HIV-positive participants are eligible
if:
o Current CD4 count ≥350 cells/uL and viral load are monitored per standard of
care by a local health care provider, without a history of AIDS-defining
opportunistic infections within the past 12 months or are not on wellestablished
o Received antiretroviral therapy (ART) (excluding strong CYP3A4 inhibitors) for
at least 4 weeks and having an HIV viral load ≤400 copies/ml prior to study
treatment and will continue ART as clinically indicated while enrolled on study.
b) Has an active hepatitis B infection. If hepatitis B surface antigen and/or hepatitis B
core antibody test results are positive, HBV DNA testing is required and the viral
load should be below the limit quantification to be eligible. (Not applicable for HCC
participants, refer to inclusion criteria #14 for HCC participants).
c) Has an active Hepatitis C virus infection; individuals who have completed curative
antiviral treatment with Hepatitis C virus viral load below the limit of quantification
are allowed. If the test for HCV antibody is positive, then HCV RNA should be
tested.
12. Has unresolved toxicities from previous anticancer therapy, defined as toxicities
(other than alopecia) not yet resolved to Grade ≤1 or baseline. Toxicities that have
resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement
hormones) are allowed, if not associated with increased risk of complications per
investigator’s assessment.
13. Has a history of allergies, hypersensitivities, or intolerance to the trial treatments
including any excipients thereof.
14. Has a history of another primary malignancy within 3 years, except adequately
resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid
tumors curatively treated or have a known additional malignancy that is progressing
or requires treatment.
15. Use of any IMP within 28 days or five half-lives if known (whichever is longer) before
administration of first dose of trial treatment or ongoing participation in the active
treatment phase of another interventional clinical trial or prior randomization or
treatment in a previous trial with the same IMPs as the current trial, regardless of
treatment assignment.
16. Has a medical, psychological, or social condition or substance abuse which, in the
opinion of the investigator, could compromise their wellbeing if they participate in the
trial, or that could prevent, limit, or confound the protocol-specified assessments or
procedures, or that could impact adherence to protocol-described requirements.
17. Is vulnerable individual as per ICH E6 definition, i.e., are individuals whose
willingness to volunteer in a clinical trial may be unduly influenced by the expectation,
whether justified or not, of benefits associated with participation, or of a retaliatory
response from senior members of a hierarchy in case of refusal to participate. This
includes all sponsor, trial site, or third party (e.g., CRO, vendor) personnel directly
involved in the conduct of the trial and their family members or dependents, as well
as all trial site personnel otherwise supervised by the investigator.
18. Has a history of small bowel obstruction requiring hospitalization within the past 3
months prior to the first dose of the IMP.
19. Has a history of unrecovered sinus tracts/fistula in the oral cavity or other parts within
28 days prior to the first dose of the IMP.
Participants who meet any of the following criteria will be excluded from the trial:
1. Prior treatment with B7H3 targeted therapy.
2. Prior treatment with antibody-drug conjugate with topoisomerase inhibitor (e.g.,
trastuzumab deruxtecan).
3. Is a candidate to locoregional treatment (including surgical resection, stereotactic
radiation therapy or tumor ablation) with potential to induce complete or near
complete response and prolonged tumor control (sometimes described as “radical”
intent), per investigator’s assessment.
4. Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the
investigator, contra-indicates trial participation, limits compliance with trial procedures
or substantially increases the risk of incurring AEs, including:
a) Bleeding diathesis or active hemorrhage,
b) Active infection,
c) Child-Pugh class B or C cirrhosis,
d) Pulmonary disease with significant impact on lung function,
e) Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior
vena cava syndrome, carcinoid syndrome that is unstable and with available
alternative therapies),
f)
Psychiatric or abuse condition.
5.
Has uncontrolled or significant cardiovascular disease including any of the following:
a)
Medical history of unstable angina, acute coronary syndrome, cerebral vascular accident or other Grade ≥3 cardiovascular events, within 6 months before randomization/enrollment or symptomatic chronic heart failure (New York Heart Association Class II to IV, see Section 12.4.2). Participants with troponin levels above ULN at screening and without any myocardial infarction related symptoms should have a cardiologic consultation before randomization/enrollment to rule out myocardial infarction.
b)
Central or symptomatic peripheral pulmonary embolism within 3 months prior to randomization/enrollment. Participants with deep venous thrombosis and incidentally diagnosed peripheral pulmonary embolism are eligible if on a stable antithrombotic regimen.
c)
Uncontrolled hypertension (defined as systolic blood pressure [BP] ≥160 mm Hg or diastolic BP ≥100 mm Hg) maintained over time and despite antihypertensive treatment, or participants with a history of hypertensive crisis or hypertensive encephalopathy.
d)
Uncontrolled and/or clinically important cardiac arrhythmias.
e)
Corrected QTcF prolongation to >470 ms based on average of screening 12 lead ECG in triplicate.
f)
Have LVEF <50% by either ECHO or MUGA within 28 days before randomization/enrollment.
g)
Poorly controlled diabetes (fasting blood glucose ≥13.3 mmol/L [240 mg/dL]).
6.
Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.
7.
Has a history of (non-infectious) ILD/pneumonitis (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
8.
Has a history of underlying pulmonary disorder including, but not limited to, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
9.
Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
10.
Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy (defined as 2 brain images, same imaging modality, both of which are obtained after treatment to the brain metastases; these imaging scans should be obtained at least 4 weeks apart and show no evidence of intracranial progression), and are on stable or decreasing doses ofcorticosteroids equivalent to ≤10 mg/day prednisone are eligible for trial entry.
Participants with untreated, asymptomatic brain metastasis for whom local therapy is
not indicated per standard of care may be eligible if neurologically stable and (if
deemed necessary by the investigator) after discussion with the sponsor’s medical
monitor. Participants at imminent risk for spinal cord compression or leptomeningeal
disease are not eligible.
11. Has a known history or a positive test at screening of any of the following:
a) HIV-1 or HIV-2 infection.
Note: For dose expansion Arms of part 2 only, HIV-positive participants are eligible
if:
o Current CD4 count ≥350 cells/uL and viral load are monitored per standard of
care by a local health care provider, without a history of AIDS-defining
opportunistic infections within the past 12 months or are not on wellestablished
o Received antiretroviral therapy (ART) (excluding strong CYP3A4 inhibitors) for
at least 4 weeks and having an HIV viral load ≤400 copies/ml prior to study
treatment and will continue ART as clinically indicated while enrolled on study.
b) Has an active hepatitis B infection. If hepatitis B surface antigen and/or hepatitis B
core antibody test results are positive, HBV DNA testing is required and the viral
load should be below the limit quantification to be eligible. (Not applicable for HCC
participants, refer to inclusion criteria #14 for HCC participants).
c) Has an active Hepatitis C virus infection; individuals who have completed curative
antiviral treatment with Hepatitis C virus viral load below the limit of quantification
are allowed. If the test for HCV antibody is positive, then HCV RNA should be
tested.
12. Has unresolved toxicities from previous anticancer therapy, defined as toxicities
(other than alopecia) not yet resolved to Grade ≤1 or baseline. Toxicities that have
resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement
hormones) are allowed, if not associated with increased risk of complications per
investigator’s assessment.
13. Has a history of allergies, hypersensitivities, or intolerance to the trial treatments
including any excipients thereof.
14. Has a history of another primary malignancy within 3 years, except adequately
resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid
tumors curatively treated or have a known additional malignancy that is progressing
or requires treatment.
15. Use of any IMP within 28 days or five half-lives if known (whichever is longer) before
administration of first dose of trial treatment or ongoing participation in the active
treatment phase of another interventional clinical trial or prior randomization or
treatment in a previous trial with the same IMPs as the current trial, regardless of
treatment assignment.
16. Has a medical, psychological, or social condition or substance abuse which, in the
opinion of the investigator, could compromise their wellbeing if they participate in the
trial, or that could prevent, limit, or confound the protocol-specified assessments or
procedures, or that could impact adherence to protocol-described requirements.
17. Is vulnerable individual as per ICH E6 definition, i.e., are individuals whose
willingness to volunteer in a clinical trial may be unduly influenced by the expectation,
whether justified or not, of benefits associated with participation, or of a retaliatory
response from senior members of a hierarchy in case of refusal to participate. This
includes all sponsor, trial site, or third party (e.g., CRO, vendor) personnel directly
involved in the conduct of the trial and their family members or dependents, as well
as all trial site personnel otherwise supervised by the investigator.
18. Has a history of small bowel obstruction requiring hospitalization within the past 3
months prior to the first dose of the IMP.
19. Has a history of unrecovered sinus tracts/fistula in the oral cavity or other parts within
28 days prior to the first dose of the IMP.
The Estimated Number of Participants
-
Taiwan
49 participants
-
Global
492 participants
