Jiangsu Vcare Unveils Phase I Clinical Trial Results of TRK Inhibitor VC004 at 2024 ASCO

　　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.