Phase 1 Study of U3-1287

Phase 1

• Conditions: Advanced solid tumors not curable with, or not eligible for standard treatment(s)

• Registration Number: JPRN-jRCT2080221225
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Histologically or cytologically diagnosed advanced solid tumors as listed below which are not curable with, or not eligible for standard treatment(s): Lung, breast, colorectal, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, hepatocellular, esophageal, malignant melanoma, or sarcoma
-ECOG performance status: 0-1

Exclusion Criteria

-History of any of the following diseases within 6 months prior to study enrollment or comorbid medical conditions: heart failure, myocardial infarction, cerebral infarction, active angina, arrhythmia requiring medication, coronary/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, or clinically significant pulmonary disease (e.g., COPD or asthma)
-Patients with any severe or uncontrolled comorbid medical conditions in spite of medications
-Has brain metastasis with clinical symptoms or requiring treatment
-Has history of bleeding diathesis (e.g., hemoptysis)
-Has history of serious drug hypersensitivity such as anaphylactoid reaction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Pharmacokinetics<br>-To evaluate the safety profile according to CTCAE<br>-To evaluate the pharmacokinetics according to the protocol

Secondary Outcome Measures

Name	Time	Method
-Incidence of anti-U3-1287 antibody<br>-Determination of the recommended dose for subsequent clinical studies<br>-Preliminary assessment of anti-tumor activity of U3-1287<br>-Exploratory study on U3-1287-related biomarkers<br><br>-To evaluate anti-tumor activity in accordance with RECIST<br>-To study potential U3-1287-related biomarkers according to the protocol