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Protocol NumberDB-1311-O-1001
Active

2024-04-01 - 2028-01-31

Phase I

Not yet recruiting1

Recruiting8

Terminated1

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-1311 in Subjects 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

Principal Investigator Wei-Hong Cheng 無
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 饒坤銘 無
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

  • 王功亮 Division of Obstetrics & Gynecology
  • 詹雅婷 Division of Obstetrics & Gynecology
  • 陳楨瑞 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Muh-Hwa Yang 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Mo Hou Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-CHEN WU Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YI-CHUN LIU Division of Radiation Therapy
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Advanced/Metastatic Solid Tumors

Objectives

To evaluate the safety and tolerability of DB-1311.  To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of DB-1311.

Test Drug

injection

Active Ingredient

DB-1311

Dosage Form

246

Dosage

50mg/mL

Endpoints

Dose-limiting toxicities (DLTs), serious
adverse events (SAEs), treatment
emergent adverse events (TEAEs), vital
sign measurements, clinical safety
laboratory parameters, electrocardiogram
(ECG) parameters, Eastern Cooperative
Oncology Group (ECOG) performance
status (PS), ECHO/MUGA findings.
Adverse events (AEs) will be graded
according to the National Cancer Institute-
Common Terminology Criteria for
Adverse Events Version 5.0 (NCI-CTCAE
v5.0).

Inclution Criteria

Unless otherwise specified, the inclusion criteria are common to both Phase 1 and Phase 2a.
Subjects must meet all of the following criteria:
1. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local
regulations at the time of voluntarily signing of informed consent).
2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that
has relapsed or progressed on or after standard systemic treatments, or is intolerable with
standard treatment; or for which no standard treatment is available.
3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1
criteria (measurable disease as defined by RANO 2.0 criteria for GBM subjects). Castrate-
resistant prostate cancer (CRPC) subjects with bone only disease may be eligible on a case-by-
case basis after discussion with the Medical Monitor.
4. Has a life expectancy of ≥ 3 months.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA)
within 28 days before enrollment.
7. Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as Table below.

Exclusion Criteria

Unless otherwise specified, the exclusion criteria are common to both Phase 1 and Phase 2a.
Subjects who meet any of the following criteria will be excluded from the study:
1. Prior treatment with B7-H3 targeted therapy.
2. Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab
deruxtecan).
3. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart
Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
4. Has a medical history of myocardial infarction or unstable angina within 6 months before
enrollment.
5. Has an average of Fredericia’s formula-QT corrected interval (QTcF) prolongation to > 470
millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in
triplicate.
6. Use of concomitant medications known to prolong the QT interval. If the use is deemed
necessary, they should be administered with caution and closely monitoring the QT interval,
after discussed with the Sponsor.
7. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia,
pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial
lung diseases or who are suspected to have these diseases by imaging at screening.
8. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary
emboli within 3 months of the start of study treatment, severe asthma, severe COPD,
restrictive lung disease, and other clinically significant pulmonary compromise or
requirement for supplemental oxygen.
9. Clinically significant gastrointestinal disorder including, but not limited to, history of
gastrointestinal fistulation that need long-term intravenous nutrition; gastrointestinal
dysfunction that need long-term enteral nutrition through the tube feeding; gastrointestinal
obstruction/perforation that not recovered within 6 months prior to the enrollment.
10. Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high
risk of bleeding; A prior bleeding event due to esophageal and/or gastric varices within 6
months prior to initiation of study treatment (Only applicable to HCC subjects).
11. Metastatic disease that involves major blood vessels (e.g., patients with vascular invasion of
the major portal vein and inferior vena cava).
12. Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage,
peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to
the enrollment.
13. 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.

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    862 participants

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