Jiangsu Vcare Unveils Phase I Clinical Trial Results of TRK Inhibitor VC004 at 2024 ASCO
Published Time:
2024-06-07 17:08
Source:
On June 2, 2024，Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) unveiled the Phase I clinical trial results of its self-developed next-generation TRK inhibitor, VC004, for the treatment of locally advanced/metastatic solid tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Abstract ID: #3101
This study is a first-in-human, multicenter, single-arm, open-label Phase I/II clinical trial (ClinicalTrials.gov Identifier: NCT04614740). The Phase I portion is designed to evaluate the safety, efficacy, and pharmacokinetic (PK) profile of VC004 in patients with locally advanced/metastatic solid tumors.
Key Findings: During the Ib dose-expansion phase, 35 patients (median age: 57.0 years; 97% with ECOG score ≤1) treated with VC004 50 mg twice daily (recommended Phase II dose, RP2D) achieved unconfirmed and confirmed ORRs of 75.9%(95% CI: 56.5–89.7) and 69.0%(95% CI: 49.2–84.7), respectively, as assessed by RECIST v1.1 criteria.
In the subgroup of patients naive to TRK-TKI treatment, the unconfirmed and confirmed ORRs reached 80.8%(95% CI: 60.6–93.4) and 73.1%(95% CI: 52.2–88.4), respectively. Median DoR and PFS were not yet reached. Notably, 28.6% of TRK-TKI treatment-naive patients maintained responses for ≥12 months, and 75.8% achieved PFS ≥9 months. Among three patients who progressed after prior TRK-TKI therapy, two exhibited tumor shrinkage, including one partial response (PR; 39.6%). Of six patients with baseline brain metastases, two experienced intracranial lesion reductions of 61.8% and 25%, while non-target lesions achieved complete resolution in two others after four months of treatment.
Safety Profile, TRAEs were predominantly Grade 1–2, with no fatal TRAEs reported. Common TRAEs (≥20%) included dizziness, weight gain, hypertriglyceridemia, anemia, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), hypercholesterolemia, and hyperuricemia. No new safety signals were observed compared to other TRK inhibitors.
VC004 demonstrated dose-proportional exposure across doses of 25–200 mg and favorable oral bioavailability.
VC004 exhibited safety comparable to first-generation TRK-TKIs and robust efficacy against NTRK fusion-positive tumors. Significant clinical benefits were observed not only in TRK-TKI treatment-naive patients but also in those with TRK-TKI resistant disease or baseline brain metastases.
Note: All data are preliminary and subject to confirmation in ongoing trials.
Related News
28
2025
/
04
Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced the successful enrollment of the first participant in its Phase II clinical trial for VC005 topical gel, a self-developed next-generation highly selective JAK1 inhibitor, for the treatment of mild-to-moderate atopic dermatitis (AD). The trial aims to evaluate the efficacy of VC005 gel in adult patients with mild-to-moderate AD, providing a critical data for dose selection in future clinical studies and further assesses the drug's safety profile.
View Details
11
2025
/
04
Recently, following joint review by Nanjing Jiangbei New Area Sci-Tech Bureau and Nanjing Municipal Science and Technology Bureau, the"Nanjing Key Laboratory for Artificial Intelligence (AI) Drug Design"established byJiangsu Vcare Pharmatech Co., Ltd.(Jiangsu Vcare) was approved as a 2025 Nanjing Key Laboratory. This marks authoritative recognition of Jiangsu Vcare’s scientific capabilities, with the Lab having achieved significant progress in drug design and molecular discovery.
View Details
26
2025
/
03
Jiangsu Vcare Launches Phase II Trial for VC005 Topical Gel in Mild-to-Moderate Atopic Dermatitis
On March 26, 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) officially launched the Phase II clinical trial for its self-developed, highly selective JAK1 inhibitor VC005 gel for the topical treatment of mild-to-moderate atopic dermatitis (AD). The completed Phase I clinical study of VC005 gel demonstrated excellent safety and significant efficacy.
View Details
27
2025
/
01
Jiangsu Vcare Honored As: National-Level Specialized, Refined, Unique, and Innovative "Little Giant" Enterprises; Top 100 China Pharma Innovation Seed Enterprises; Jiangsu Listed Sci-Tech Enterprise Cultivation Program; Jiangsu Chemical Innovative Drug Engineering Research Center; Top 500 China Hidden Unicorn Enterprises
View Details
26
2025
/
01
In January 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced that its self-developed next-generation anti-resistant TRK inhibitor VC004 capsule has officially entered the domestic NDA preparation phase, initiating pre-NDA communications with regulatory authorities. Marking this milestone, Jiangsu Vcare has joined the top tier of domestic self-developed drugs targeting this pathway at remarkable speed.
View Details
22
2025
/
01
Jiangsu Vcare Secures Nearly CNY 200 Million in Series C+ Financing
Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) closed its Series C+ financing round, raising nearly CNY 200 million. The round was jointly invested by Xinghe Venture Capital, Jinlong Investment, SDIC Capital, and Yangtze River Industry Group. The proceeds will accelerate clinical advancement of Jiangsu Vcare’s innovative drug pipelines, strengthen its integrated CRO/CDMO service ecosystem, enhance independent innovation capabilities, and advance strategic initiatives in synthetic biology and green chemistry. This brings Jiangsu Vcare’s total equity financing to over CNY 1 billion, demonstrating sustained capital market confidence.
View Details
Company Address:
No. 136, Huakang Road, Jiangbei New Area, Nanjing, P. R. China
Subsidiary NJVcare Website：
Scan to see
Copyright © JIANGSU VCARE PHARMATECH CO.,LTD.
Powerby：www.300.cn nanjing.300.cn