In short
Clinical trials are investigating VISUGROMAB in several cancer settings and in cancer-associated cachexia. These studies are checking how well it works, how safe it is, and which patients may benefit, including people with advanced lung cancer, bladder cancer, liver cancer, and weight loss related to cancer.
Key points
- Clinical trials of VISUGROMAB are being done in several cancer settings and in cancer-associated cachexia. Most studies are Phase 2, with one Phase 1 study in advanced relapsed or refractory solid tumors and one Phase 4 study in cachexia. The target groups include people with metastatic non-squamous non-small cell lung cancer, muscle-invasive bladder cancer, unresectable or metastatic hepatocellular carcinoma, and advanced solid tumors. The trials are testing VISUGROMAB alone or with other treatments such as nivolumab, pembrolizumab, docetaxel, carboplatin, pemetrexed, and lenvatinib. Main outcomes include tumor response, progression-free survival, surgery findings, body weight, appetite, and safety measures.
Trial overview
Several interventional trials are studying VISUGROMAB in people with cancer and in people with cancer-associated cachexia.
Most of these studies are Phase 2 trials, one is a Phase 1 trial, and one is a Phase 4 trial.
The studies are authorised and use a mix of VISUGROMAB alone, VISUGROMAB with other cancer treatments, or placebo comparisons.
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.
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.
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.
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.
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.
This study includes people who cannot receive cisplatin-based chemotherapy or refuse it.
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.
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.
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.
“First-in-human” means this is the first time the treatment was tested in people in this study program.
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.
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.
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.
This study includes participants with compensated liver function, called Child-Pugh A, which means the liver is still working well enough for this classification.
The trial compares VISUGROMAB plus nivolumab and lenvatinib against double placebo and lenvatinib in people who had already failed anti-PD-(L)1 treatment.
The primary outcome is progression-free survival, which measures how long people live without the cancer getting worse or death occurring first.
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.
This trial compares VISUGROMAB with placebo matching VISUGROMAB and includes a large planned enrollment of 626 participants.
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.
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.
The liver cancer trial focuses on progression-free survival, while the cachexia study focuses on body weight and appetite changes.
The Phase 1 trial also records safety data such as adverse events, laboratory results, vital signs, ECG findings, physical exam results, and performance status.
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.