Table of contents

• Trial overview
• Lung cancer studies
• Bladder cancer study
• Advanced solid tumors study
• Liver cancer study
• Cancer-associated cachexia study
• Outcomes and safety measures

Trial overview

Several interventional trials are studying VISUGROMAB in people with cancer and in people with cancer-associated cachexia.^{[1][2][3][4][5][6]}

Most of these studies are Phase 2 trials, one is a Phase 1 trial, and one is a Phase 4 trial.^{[1][2][3][4][5][6]}

The studies are authorised and use a mix of VISUGROMAB alone, VISUGROMAB with other cancer treatments, or placebo comparisons.^{[1][2][3][4][5][6]}

Lung cancer studies

Two Phase 2 trials are studying VISUGROMAB in metastatic non-squamous non-small cell lung cancer, which means lung cancer that has spread and is not the squamous type.^[1][3]

One trial is in second-line treatment, meaning it is for participants whose earlier treatment has already been used, and it compares VISUGROMAB plus nivolumab with or without docetaxel against placebo-based treatment.^[1]

The second lung cancer trial is in first-line treatment, meaning it is used at the start of treatment, and it compares VISUGROMAB plus immunochemotherapy against placebo plus the same immunochemotherapy.^[3]

Both lung cancer trials measure objective response rate, which is the share of participants whose tumors shrink enough to count as a complete or partial response.^[1][3]

Bladder cancer study

One Phase 2 study is testing VISUGROMAB in muscle invasive bladder cancer for participants who are set to undergo radical cystectomy, which is surgery to remove the bladder.^[2]

This study includes people who cannot receive cisplatin-based chemotherapy or refuse it.^[2]

The trial compares VISUGROMAB plus an anti-PD-1 checkpoint inhibitor with the anti-PD-1 treatment alone in the neoadjuvant setting, which means treatment given before surgery.^[2]

The main outcomes are pathological complete response and radiological response rate, so the study looks at both tissue findings after treatment and tumor changes on scans.^[2]

Advanced solid tumors study

One first-in-human Phase 1 study is testing CTL-002, which is named as VISUGROMAB in the trial data, in people with advanced-stage, relapsed/refractory solid tumors.^[4]

“First-in-human” means this is the first time the treatment was tested in people in this study program.^[4]

The study includes participants with bladder cancer, hepatocellular cancer, non-small cell lung cancer, melanoma, colorectal cancer with microsatellite stable or mismatch-repair competent disease, and a mixed “basket” cohort of solid tumors.^[4]

The trial looks at early anti-tumor activity and also checks safety and tolerability using side effects, lab tests, vital signs, ECGs, physical exams, neurological checks, and ECOG performance status.^[4]

Liver cancer study

One Phase 2 trial is studying VISUGROMAB in unresectable or metastatic hepatocellular carcinoma, which is liver cancer that cannot be removed with surgery or has spread.^[5]

This study includes participants with compensated liver function, called Child-Pugh A, which means the liver is still working well enough for this classification.^[5]

The trial compares VISUGROMAB plus nivolumab and lenvatinib against double placebo and lenvatinib in people who had already failed anti-PD-(L)1 treatment.^[5]

The primary outcome is progression-free survival, which measures how long people live without the cancer getting worse or death occurring first.^[5]

Cancer-associated cachexia study

One Phase 4 study is testing VISUGROMAB in cancer-associated cachexia, a condition linked to cancer that causes weight loss and poor appetite.^[6]

This trial compares VISUGROMAB with placebo matching VISUGROMAB and includes a large planned enrollment of 626 participants.^[6]

The main outcomes are change in body weight and change in appetite after 12 weeks, using the 5-item anorexia subscale of the FAACT tool for appetite measurement.^[6]

Outcomes and safety measures

The lung cancer and bladder cancer trials focus on tumor response, including complete response, partial response, and radiological response on scans.^[1][2][3]

The liver cancer trial focuses on progression-free survival, while the cachexia study focuses on body weight and appetite changes.^[5][6]

The Phase 1 trial also records safety data such as adverse events, laboratory results, vital signs, ECG findings, physical exam results, and performance status.^[4]

Across these studies, VISUGROMAB is being tested in different patient groups, so the main goal is to learn where it may help most and how it performs in each setting.^{[1][2][3][4][5][6]}