ITC-6146RO / IntoCell - LARVOL DELTA

A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy (clinicaltrials.gov) - P1 | N=102 | Not yet recruiting | Sponsor: IntoCell, Inc

First-in-human • New P1 trial • Breast Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

On December 2, Intocell announced that it has received approval from the Ministry of Food and Drug Safety for its Phase 1 clinical trial plan (IND) for the investigational treatment 'ITC-6146RO' targeting advanced solid tumors. (The Asia Business Daily) - "The clinical trial will enroll up to 102 patients with advanced or metastatic cancers who have failed standard therapies. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of ITC-6146RO."

New P1 trial • Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

IntoCell Receives FDA IND Approval for Advanced Solid Tumor Treatment 'ITC-6146RO' (The Asia Business Daily) - "This clinical trial will enroll up to 102 patients with advanced or metastatic cancer who have failed standard of care (SoC) therapies. ITC-6146RO will be administered to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy....The phase 1a study will assess dose escalation, while phase 1b will evaluate dose expansion. The recommended phase 2 dose will be determined during phase 1. In phase 1b, anti-tumor effects in mCRPC, NSCLC, and TNBC will be evaluated."

IND • New P1 trial • Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

IntoCell submits phase 1 trial plan for cancer drug ITC-6146RO in Korea (Chosun Biz) - "IntoCell plans to conduct a phase 1 clinical trial evaluating safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor effects targeting patients with progressive or metastatic cancer who have failed standard treatment as soon as it receives IND approval."

New P1 trial • Oncology