The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors
NCT ID: NCT04614740
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
115 participants
INTERVENTIONAL
2020-11-20
2024-06-30
Brief Summary
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According to the tolerability and pharmacokinetic results of dose-escalation study , an appropriate dose or MTD will be selected, namely RP2D, to further assess anti-tumor efficacy and safety in patients with NTRK fusion-positive locally advanced/metastatic solid tumors . ORR will be chosen as the main efficacy indicator to evaluate the anti-tumor efficacy and safety of VC004 .
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VC004
1\. Dose escalation stage: subjects in the 50 mg, 100 mg, 200 mg, and 300 mg dose groups took a single oral dose on the first day; starting from the fourth day, each group of subjects took the corresponding dose twice a day. 2. Dose expansion stage: subjects in the 100mg and 200mg dose groups took the corresponding dose twice a day on an empty stomach; 3. Phase II clinical trial stage: oral administration twice a day before meals, and the dosage is to be determined.
VC004
25 mg capsules,50 mg capsules,100 mg capsules.
Interventions
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VC004
25 mg capsules,50 mg capsules,100 mg capsules.
Eligibility Criteria
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Inclusion Criteria
* Male or female, age ≥18 years old
* Patients with locally advanced or metastatic solid tumors diagnosed by histology or cytology, or currently have no standard treatment, have failed the standard treatment, or are intolerant to the standard treatment or are not suitable for the standard treatment at this stage。 The first part of the dose escalation stage: locally advanced or metastatic solid tumors, including but not limited to salivary gland cancer, thyroid cancer, soft tissue sarcoma, liposarcoma, etc.
* Subject's baseline lesion requirements: According to the definition of RECIST v1.1 or RANO, the subject must have at least one measurable lesion (applicable to NTRK fusion-positive locally advanced or metastatic solid tumors)。
* Subjects with primary central nervous system (CNS) tumors must meet the following criteria (only the first part of the dose expansion phase and the second part are applicable)
* According to the guidelines or CNS tumor type, have received treatment including radiotherapy and/or chemotherapy, and the interval between radiotherapy and the first treatment with study drug is at least 12 weeks.
* According to the definition of RANO, there is at least one measurable lesion in magnetic resonance imaging (MRI), which can be visualized on ≥2 axial films with a thickness of 5 mm, and the longitudinal diameters perpendicular to each other are\> 10 mm.
* The imaging examination was performed within 28 days before enrollment. If you receive glucocorticoid treatment, a stable dose of glucocorticoid is required at least 5 days before imaging evaluation.
* The Eastern Cooperative Oncology Group (ECOG) score is ≤2 points (0-1 points are required for the dose-escalation stage)
* The estimated survival time is ≥12 weeks.
* The subject must have appropriate organ and hematological functions (have not received blood transfusion, EPO, G-CSF or other medical supportive treatment within 14 days before the administration of the study drug)。
* Premenopausal women who are likely to have children must have a pregnancy test within 7 days before starting treatment. The pregnancy test must be negative and must be non-lactating; Infertile women may not undergo pregnancy tests and contraception, but they must meet the following requirements: age 50 years or older, not using hormone therapy and menopause for at least 12 months, or have undergone sterilization. All enrolled patients (whether male or female) should take adequate contraceptive measures throughout the treatment period and 180 days after the end of treatment.
Exclusion Criteria
* Patients have used any cytotoxic chemotherapeutic agents, targeted therapies, immunotherapies, or other anti-cancer drugs in the previous regimen within 4 weeks before the first administration ( e.g.Nitrosourea or mitomycin C for 6 weeks prior to first use of study drug, Oral fluorouracil and small-molecule targeted drugs are administered 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug, whichever is longer.).
* The time from receiving other experimental drugs or analogues to the first dose does not exceed the drug's 5 half-life or 14 days (whichever is longer).
* Patients have used chinese herbal medicines and chinese herbal preparations with antitumor as an indication, chinese herbal medicines and chinese herbal preparations with tumor adjuvant therapeutic effect within 14 days before the first administration.
* Patients have undergone major surgery within 4 weeks prior to the first dose or are expected to undergo major surgery during the trial (excluding vascular access establishment procedures, biopsy procedures)
* Adverse reactions caused by previous treatment have not recovered to ≤1 grade (the dose-escalation stage does not include ≤2 grade hair loss, and the dose expansion stage and phase II clinical trials are comprehensively evaluated by the investigator).
* Primary central nervous system malignancy (only the first part of the dose escalation phase).
* Patients are known to have symptomatic or untreated brain metastases or other central nervous system metastases.CNS lesions that remain stable or show improvement after treatment with complete resection and/or radiation therapy are excluded, but require no glucocorticoids to control neurological symptoms within 14 days prior to entry into this study.
* There is any clinical basis suggesting a severe or uncontrolled systemic disease for which the investigator believes the patient is unsuitable for trial participation or which would affect the patient's compliance with the study protocol, such as stable or decompensated respiratory disease, cerebrovascular disease, liver disease, renal disease, uncontrolled diabetes, aortic dissection, aortic aneurysm, active bleeding-prone body, or those requiring systemic anti-infective therapy.
* Any clinically serious gastrointestinal abnormality that may affect the ingestion, transit, or absorption of study drugs.
* Patients have clinically significant cardiovascular diseases, including：
* Left ventricular ejection fraction (LVEF) ≤ 50% by echocardiography during the screening period
* Heart Failure, New York Heart Association (NYHA) grade III and above
* Poorly controlled hypertension (BP ≥ 150/100 mmHg despite use of optimal therapy)
* Past or current cardiomyopathy
* Patients with atrial fibrillation and severe arrhythmia with ventricular rate\> 100 bpm
* Unstable ischemic heart disease (myocardial infarction (MI) within 6 months prior to starting study treatment, or angina that requires \>1 nitrate per week to control symptoms)
* QTcF interval ≥450ms for males and ≥470ms for females (Fredericka formula: QTcF = QT/RR0.33)
* Patients had been treated with a strong CYP3A inhibitor or inducer within 7 days prior to the first administration of the study drug.
* Currently existing hepatitis B (hepatitis B surface antigen \[HbsAg\] positive or core antibody \[HbcAb\] positive and HBV DNA positive), hepatitis C (HCV anti-positive and HCV RNA positive), human immunodeficiency virus (HIV) infection and syphilis infection.
* Patients whom the investigators determine are not suitable for participation in the study for other reasons.
* Subjects are unwilling or unable to follow the protocol process.
18 Years
ALL
No
Sponsors
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Jiangsu vcare pharmaceutical technology co., LTD
INDUSTRY
Responsible Party
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Principal Investigators
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yuankai shi
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Hainan Cancer Hospital
Haikou, Hainan, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical Univercity Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Zhujiang Hospital of Southern Medical University
Guangzhou, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
Tianjin Cancer Hospital
Tianjin, , China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, , China
Hubei Cancer Hospital
Wuhan, , China
Countries
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Central Contacts
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Facility Contacts
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Jingmo Yang
Role: primary
Yuanyuan Yin
Role: primary
Ping Huang
Role: primary
Yu Lei
Role: primary
Lin Na
Role: primary
Zhuo Sun
Role: primary
Xiang Li
Role: primary
Yuefang Cheng
Role: primary
Yun Jiang
Role: primary
Jungang Yin
Role: primary
Huijuan Li
Role: primary
Fei Teng
Role: primary
Guozhong Wang
Role: primary
Sanhua Na
Role: primary
Feiyan Li
Role: primary
Ning Li
Role: primary
Shixiang Zheng
Role: primary
Lixuan Wei
Role: primary
Jinhuai Xue
Role: primary
Bugela
Role: primary
Li
Role: primary
Other Identifiers
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VC004-101
Identifier Type: -
Identifier Source: org_study_id