Velmarto (eratrectinib) / Jiangsu Vcare Pharma - LARVOL DELTA

August 6, the NMPA granted approval to Geneseeq’s PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO (Eratrectinib), a next‑generation highly selective TRK inhibitor independently developed by Vcare PharmaTech (PRNewswire) - "The approval provides critical support for the precise identification and clinical medication of patients with NTRK fusion‑positive solid tumors....As the original companion diagnostic for Eratrectinib, PanTRKare addresses key testing challenges including the pan‑tumor distribution, low incidence and complex fusion patterns of NTRK1/2/3 fusions, enabling accurate detection of NTRK fusion variants across diverse cancer types."

China approval • Diagnostic • Solid Tumor

A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of VC004 Capsules for Pain in Bone Metastases (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P1 trial • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

On June 4, the official website of the NMPA announced that Vcare PharmaTech’s Class 1 new drug, Eratrectinib (VELMARTO), has been approved for marketing in China (Jiangsu Vcare Press Release) - "It is indicated for adult and adolescent patients with advanced solid tumors harboring NTRK gene fusions."

China approval • Solid Tumor

Safety, efficacy, and pharmacokinetics of eratrectinib (VC004) in solid tumors with NTRK fusions: phase 1 results from a phase 1/2 study. (PubMed, Exp Hematol Oncol) - P2 | "Eratrectinib demonstrated manageable safety profile and promising efficacy in patients with NTRK fusion positive solid tumors, representing a new treatment option for this patient population. Further studies to confirm the efficacy and safety of eratrectinib are ongoing. Trial registration NCT04614740 (ClinicalTrials.gov)."

Journal • P1/2 data • PK/PD data • Dyslipidemia • Hematological Disorders • Hypertriglyceridemia • Oncology • Solid Tumor • NTRK

Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors (clinicaltrials.gov) - P3 | N=54 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2024 ➔ Mar 2025

Enrollment open • Trial initiation date • Oncology • Solid Tumor

A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors (clinicaltrials.gov) - P3 | N=54 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P3 trial • Oncology • Solid Tumor

A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P1 trial • Oncology • Solid Tumor

Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Aug 2024 | Trial primary completion date: Dec 2024 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P1 trial • Oncology • Solid Tumor

Safety, efficacy and pharmacokinetics of VC004, a highly selective next-generation pan-TRK inhibitor, in patients with locally advanced/metastatic solid tumors. (ASCO 2024) - P2 | "VC004 showed a manageable safety profile and promising efficacy against NTRK fusion-positive tumors. The phase 2 study has recently been initiated."

Clinical • Metastases • PK/PD data • Anemia • Dyslipidemia • Hematological Disorders • Hypertriglyceridemia • Metabolic Disorders • Oncology • Solid Tumor • NTRK

ETV6::NTRK3 gene fusion in a patient with metastatic lung atypical carcinoid successfully treated with repotrectinib: A case report. (PubMed, Lung Cancer) - "To the best of our knowledge, we reported the first case demonstrating anti-tumor activity of repotrectinib in a patient with AC carring an ETV6-NTRK3 gene fusion, indicating that repotrectinib may be an efficient therapeutic option for tumors with NTRK gene rearrangements."

Biomarker • Clinical • Journal • Metastases • Observational data • P1 data • P2 data • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ETV6 • NTRK • NTRK1 • NTRK2 • NTRK3

Food Effect on the Pharmacokinetics of VC004, a Tropomyosin Receptor Kinase Inhibitor: A Randomized Crossover Trial in Healthy Chinese Subjects. (PubMed, Clin Drug Investig) - "The intake of high calorie food decreased the absorption rate and increased the T of VC004, while the AUC values were similar in both groups. No serious adverse event was reported. In conclusion, food does not alter the pharmacokinetics and safety profile of VC004 in a clinically meaningful manner."

Journal • PK/PD data • Oncology • Solid Tumor • NTRK

Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Nov 2022 | Trial primary completion date: Sep 2023 ➔ Oct 2022

Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P1 trial • Oncology • Solid Tumor

The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P2; N=115; Recruiting; Sponsor: Jiangsu vcare pharmaceutical technology co., LTD; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor • Thyroid Gland Carcinoma • NTRK

The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P2; N=115; Not yet recruiting; Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Clinical • New P2 trial • Oncology • Solid Tumor • Thyroid Gland Carcinoma • NTRK