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Locally Advanced Solid TumorPhase 1/2NCT04614740

The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors

A Phase 1/2 study testing VC004 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Jiangsu vcare pharmaceutical technology co., LTD at 21 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Dose-escalation study will be conducted in patients with locally advanced/metastatic solid tumors who have failed standard treatment, or cannot tolerate standard treatment, or have no recommended standard treatment, or do not apply standard treatment, to evaluate the safety, PK, tolerability and effectiveness of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VC004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
21 sitesChina
Study dates
20 Nov 2020to 30 Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects or legal representatives are willing and able to sign ICF approved by the ethics committee before starting any screening procedures；
  • 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.
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  • 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.

Who cannot join

  • Patients have previously received any of the following treatments:
  • 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).
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  • 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.

Trial locations and contacts

21 sites in 1 country.

xiaojuan lai contact

15358160458

lai_xiaojuan@vcarepharmatech.com

21 sites in 1 country

China21 sites, 21 recruiting

  • Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

    Ning Li

    Yuankai Shi

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Yun Jiang

    Gang Huang

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Yuanyuan Yin

    Yongsheng Li

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350001

    Ping Huang

    Yu Chen

    Not yet recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou

    Shixiang Zheng

    Ting Wei

    Recruiting

  • Hainan Cancer Hospital

    Haikou, Hainan, 570312

    Lin Na

    Zhixia Wei

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Feiyan Li

    Meiyu Fang

    Not yet recruiting

  • Harbin Medical Univercity Cancer Hospital

    Harbin, Heilongjiang, 150081

    Xiang Li

    Qingyuan Zhang

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230001

    Jingmo Yang

    Hu Li

    Not yet recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Huijuan Li

    Dongyuan Zhu

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650106

    Sanhua Na

    Yanbin Xiao

    Not yet recruiting

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu

    Jungang Yin

    Jun Qian

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

    Yu Lei

    Hongxue Wang

    Not yet recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

    Fei Teng

    Qing Xu

    Not yet recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Lixuan Wei

    Zhendong Li

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Zhuo Sun

    Da Jiang

    Not yet recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

    Guozhong Wang

    Shuqing Wei

    Not yet recruiting

  • Tianjin Cancer Hospital

    Tianjin

    Jinhuai Xue

    Guowen Wang

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

    Bugela

    Huarong Zhao

    Recruiting

  • Hubei Cancer Hospital

    Wuhan

    Li

    Youhua Zhu

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Yuefang Cheng

    Suxia Luo

    Recruiting

Other trials in China

About this study

Official title: Single-arm, Open, Multi-center Phase I/Phase II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetic and Effectiveness of VC004

Dose-escalation study will be conducted in patients with locally advanced/metastatic solid tumors who have failed standard treatment, or cannot tolerate standard treatment, or have no recommended standard treatment, or do not apply standard treatment, to evaluate the safety, PK, tolerability and effectiveness of VC004. According to the efficacy, safety and PK of dose-escalation study , the investigator and the sponsor jointly determine the dose for dose extension, and evaluate the anti-tumor effect of VC004 on NTRK fusion-positive subjects, and provide more information for RP2D.

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 .

Being tested
VC004
Keywords
Safety, Tolerability, Pharmacokinetic, Effectiveness
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VC004Drug

    25 mg capsules,50 mg capsules,100 mg capsules.

Study groups in NCT04614740
Study groupRoleWhat they receive
VC004Experimental1. 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.
Receives: Drug: VC004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety&Tolerability

    Adverse events (CTCAE5.0)and/or laboratory testsand/or electrocardiogramand/or echocardiogramand/or vital signsand/or physical examination

    Measured: 4 years

  2. Phase II recommended dose(RP2D)

    According to the tolerability and pharmacokinetic results of different dose groups completed during the dose escalation phase, an appropriate dose or MTD is selected as RP2D

    Measured: 1.5 years

  3. Maximum tolerated dose(MTD)(If any)

    If ≥2 cases of DLT are observed at a certain dose (up to 6 subjects), the dose will be considered an intolerable dose, and the previous dose group will be regarded as MTD

    Measured: 1.5 years

  4. Objective response rate(ORR)

    The proportion of subjects whose best overall response is CR or PR in the study assessed by IRC/investigator according to RECIST v1.1 or RANO

    Measured: 4 years

Secondary outcomes (8)

  1. Maximum Observed Plasma Concentration (Cmax)

    Measured: 0 min ，15 min，30 min，1 hour (h)，2 h，3 h，4 h，6 h，8 h，12 h，24 h，48 h

  2. Peak time(Tmax)

    Measured: 0 min ，15 min，30 min，1 hour (h)，2 h，3 h，4 h，6 h，8 h，12 h，24 h，48 h

  3. half-time（t1/2）

    Measured: 0 min ，15 min，30 min，1 hour (h)，2 h，3 h，4 h，6 h，8 h，12 h，24 h，48 h

  4. Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）

    Measured: 0 min ，15 min，30 min，1 hour (h)，2 h，3 h，4 h，6 h，8 h，12 h，24 h，48 h

  5. Apparent volume of distribution(Vz/F)

    Measured: 0 min ，15 min，30 min，1 hour (h)，2 h，3 h，4 h，6 h，8 h，12 h，24 h，48 h

  6. Duration of Remission (DOR)

    Time from the first recording of remission (CR or PR) to the first recording of disease progression or death (whichever occurs first)

    Measured: 2.5 years

  7. Progression-free survival (PFS)

    The time from the subject receiving the first study treatment to the appearance of disease progression or death from any cause (whichever occurs first)

    Measured: 2.5 years

  8. Overall survival (OS)

    The time from the date of first medication to the date of death from any cause

    Measured: 2.5years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2020
  2. Study start20 Nov 2020
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm clinical study
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04614740
Sponsor's protocol ID
VC004-101
Status last verified
Oct 2022
First submitted
12 Oct 2020
Last updated
13 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou S, Zhang C, Wang G, Qian J, Huang G, Wang J, Luo S, Zhu Y, Zhang Q, Wei T, Li Y, Li Z, Zhu D, Zhao H, Fang M, Zhou S, Xu Q, Chen Y, Nan K, Cui J, Zhu X, Gong Y, Wu Y, Lai X, Shi Y. Safety, efficacy, and pharmacokinetics of eratrectinib (VC004) in solid tumors with NTRK fusions: phase 1 results from a phase 1/2 study. Exp Hematol Oncol. 2026 Jun 26. doi: 10.1186/s40164-026-00799-9. Online ahead of print.

    PubMed 42351304

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VC004 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Jiangsu vcare pharmaceutical technology co., LTD at 21 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact xiaojuan lai (15358160458, lai_xiaojuan@vcarepharmatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety&Tolerability (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04614740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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