VC004 / Jiangsu Vcare Pharma - LARVOL DELTA

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