Clinical Trials List
2024-08-15 - 2026-12-31
Phase I/II
Not yet recruiting5
Recruiting4
ICD-10C45.9
Mesothelioma, unspecified
ICD-10C79.9
Secondary malignant neoplasm of unspecified site
ICD-10C7A.00
Malignant carcinoid tumor of unspecified site
ICD-10C7A.094
Malignant carcinoid tumor of the foregut NOS
ICD-10C7A.095
Malignant carcinoid tumor of the midgut NOS
ICD-10C7A.096
Malignant carcinoid tumor of the hindgut NOS
ICD-10C7A.1
Malignant poorly differentiated neuroendocrine tumors
ICD-10C7A.8
Other malignant neuroendocrine tumors
ICD-10C7B.00
Secondary carcinoid tumors, unspecified site
ICD-10C80.1
Malignant (primary) neoplasm, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9199.1
Malignant neoplasm of unspecified site (primary) (secondary)
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
-
Sponsor
臺灣泰格國際醫藥股份有限公司
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 沈書慧 Division of Radiology
- Mei-Ju Chen Division of Ophthalmology
- Yi-Jen Chen Division of Obstetrics & Gynecology
- Huann-Cheng Horng Division of Obstetrics & Gynecology
- 楊思婷 Division of Obstetrics & Gynecology
- Yen-Hou Chang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 張端瑩 Division of Hematology & Oncology
- 黃柏翔 Division of Hematology & Oncology
- 林柏翰 Division of General Internal Medicine
- 陳怡君 Division of Hematology & Oncology
- YEN-SHEN LU Division of Hematology & Oncology
- 林季宏 Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- 羅喬 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 廖立民 Division of Hematology & Oncology
- Yao-Yu Hsieh 無
- 莊博雅 Division of Hematology & Oncology
- TSU-YI CHAO Division of Hematology & Oncology
- KA-WAI TAM 無
- HUI-WEN LIU Division of Hematology & Oncology
- 蘇智銘 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Pertuzumab
Dosage Form
246
Dosage
420mg/vial
Endpoints
o Dose-limiting toxicity (DLT)
o Serious adverse event (SAE)
o Treatment emergent adverse event
(TEAE)
o ≥Grade 3 TEAE
o TEAE leading to dose
reduction/interruption/discontinuation
o TEAE of special interest (AESI)
o Vital signs
o 12-lead electrocardiograms (ECGs)
o Safety laboratory tests
o Eastern Cooperative Oncology Group
(ECOG) performance status (PS)
o Left ventricular ejection fraction (LVEF)
measured by echocardiography or
multiple-gated acquisition
(ECHO/MUGA)
Inclution Criteria
2. Has at least one measurable lesion as assessed by the investigator according to response
evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
3. Is capable of comprehending study procedures and risks outlined in the informed consent
and is able to provide written consent.
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
5. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition
(MUGA) within 28 days before Day 1.
6. Has adequate organ function within 7 days prior to initiation of the first Treatment Cycle
(without receiving erythropoietin [EPO], granulocyte colony-stimulating factor [G-CSF],
or granulocyte-macrophage colony stimulating factor [GM-CSF] within 14 days and
blood, red blood cell [RBC], platelet transfusion within 7 days prior to the testing), defined
as:
Hematology:
Platelet count ≥ 100 000/mm3 without transfusion
Hemoglobin (Hb) ≥ 8.5 g/dL
Absolute neutrophil count (ANC) ≥ 1500/mm3 without granulocyte colony stimulating
factor support.
Renal Function:
Creatinine clearance ≥ 50 mL/min (calculated using Cockcroft-Gault equation, see Section
10.7, or according to local institutional standard method)
Hepatic Parameters:
AST/ALT ≤ 3 × ULN (if liver metastases are present, ≤ 5 × ULN)
Total bilirubin ≤ 1.5 × ULN
PT and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
7. Has adequate washout period prior to initiation of the first Treatment Cycle defined as:
Chemotherapy (including antibody drug therapy) ≥ 3 weeks (≥ 2 weeks for 5-fluorouracil-
based agents, folinate agents and/or weekly Paclitaxel. ≥ 6 weeks for nitrosoureas or
mitomycin C).
Immunotherapy ≥ 4 weeks.
Hormonal therapy ≥ 2 weeks except gonadotropin-releasing hormone (GnRH) agonists or
antagonists for prostate cancer or oral contraceptives.
Exclusion Criteria
1. Has a medical history of symptomatic CHF (New York Heart Association [NYHA]
classes II-IV) or serious cardiac arrhythmia requiring treatment.
2. Has a medical history of myocardial infarction or unstable angina within 6 months before
Day 1.
3. Has an average of Fredericia’s formula-QT corrected interval (QTcF) prolongation to >
450 millisecond (ms) in males and > 470 ms in females based on a 12-lead
electrocardiogram (ECG) in triplicate.
4. Have a history of (non-infectious) ILD/pneumonitis that required steroids, have current
ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at
screening.
5. Have a lung-specific intercurrent clinically significant illness including, but not limited to,
any underlying pulmonary disorder (i.e., pulmonary emboli within 3 months prior to the
first dose of study drug, severe asthma, severe chronic obstructive pulmonary disorder,
restrictive lung disease, significant pleural effusion etc.), and any autoimmune, connective
tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis,
Sjogren’s syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).
6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or
antifungals.
7. Has human immunodeficiency virus (HIV) infection with acquired immune deficiency
syndrome (AIDS) defining illness; subjects who have had HIV infection with a cluster of
differentiation 4 (CD4)+ T cell count > 350 cells/µL and no history of an AIDS-defining
illness are eligible for entry. Subjects who have active viral (any etiology) hepatitis are
excluded. Subjects with serologic evidence of chronic hepatitis B virus (HBV) infection
(defined by a positive hepatitis B surface antigen [HBsAg] test and a positive hepatitis B
core antibody test) who have a viral load below the limit quantification (HBV DNA titer <
1000 cps/mL or 200 IU/mL) and are not currently on viral suppressive therapy may be
eligible and after discussion between the Investigator and the Sponsor Medical Monitor
(or his/her designee). Subjects with a history of hepatitis C virus (HCV) infection have to
complete curative antiviral treatment and have a viral load below the limit of
quantification to be eligible for study entry.
The Estimated Number of Participants
-
Taiwan
10 participants
-
Global
688 participants
