Investigational Drug
Visugromab
TrialFetch AI Analysis
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Overview
Visugromab (CTL-002) is an investigational antibody being studied for cancer treatment. Human results have been reported, principally from a phase 1/2a trial combining it with nivolumab in people whose advanced cancers had progressed during prior PD-1/PD-L1 immunotherapy. The published results are preliminary: the trial had no randomized control group, so they cannot establish how much benefit visugromab adds to nivolumab. (link.springer.com)
Mechanism of action
Visugromab neutralizes growth differentiation factor 15 (GDF-15), a protein that can impede immune-cell entry into tumors. The intended effect is to improve antitumor T-cell activity and potentially counter resistance to PD-1 blockade. Tumor samples collected during the trial showed increased T-cell infiltration and activity, supporting the proposed mechanism but not proving clinical benefit. (link.springer.com)
Efficacy
In a 2026 long-term analysis of 77 patients treated with visugromab plus nivolumab, the objective response rate was 16.9% (13/77) across three cancer groups: 18.2% (4/22) in non-squamous non-small-cell lung cancer, 18.5% (5/27) in urothelial cancer, and 14.3% (4/28) in hepatocellular cancer. Median response duration among the 13 responders was 28.8 months; seven responses were ongoing at the analysis cutoff. These response rates should not be interpreted as evidence that the combination outperforms other treatments without a randomized comparison. (link.springer.com)
Safety
Among 84 patients in the safety analysis, 56.0% had an adverse event judged related to treatment, 11.9% had a grade 3 or higher treatment-related event, and 3.6% stopped treatment because of one. Two fatal events were assessed as at least possibly related to visugromab and/or nivolumab; the contribution of each drug could not be established. (link.springer.com)
Further reading
Last updated: Sep 2026
Active trials using Visugromab
Found 3 active trials using this drug:
TrialFetch AI summary: Adults with unresectable or metastatic HCC, ECOG 0–1, and Child-Pugh A liver function who have failed exactly one prior anti-PD-(L)1–containing regimen receive lenvatinib plus either visugromab and nivolumab or placebos. Visugromab is an investigational antibody that neutralizes GDF-15 to potentially enhance antitumor T-cell activity; nivolumab inhibits PD-1.
ClinicalTrials.gov ID: NCT07219459
TrialFetch AI summary: Adults with metastatic non-squamous NSCLC, ECOG 0–1, and no actionable alteration are eligible after progression on their sole prior metastatic regimen containing a PD-(L)1 inhibitor. The trial compares docetaxel alone with nivolumab plus investigational visugromab, a GDF-15–neutralizing antibody, with or without docetaxel.
ClinicalTrials.gov ID: NCT07246863
TrialFetch AI summary: Adults with untreated stage IV nonsquamous NSCLC, ECOG 0–1, and no actionable alteration warranting targeted therapy receive first-line pembrolizumab, pemetrexed, and carboplatin plus visugromab or placebo. Visugromab is an investigational antibody that neutralizes GDF-15 to potentially enhance antitumor T-cell activity.
ClinicalTrials.gov ID: NCT07098988
