Our
Clinical Trials

We believe people living with cancer and their healthcare providers play a central role in developing the medicines of tomorrow. This page is dedicated to providing key information around CatalYm’s clinical trials, our focus indications and how we are advancing the clinical development of visugromab.

Patients and caregivers can find a layperson-friendly overview of our candidate visugromab and how it works, general information on what clinical trials are and how they are conducted, as well as practical details to consider when exploring potential trial participation.

Healthcare professionals who would like to learn more about trial eligibility criteria, participating sites, and patient referral options can browse through our clinical trials below or via ClinicalTrials.gov.

Our Clinical Trials

GDFATHER-NSCLC-01

Non-squamous metastatic NSCLC

Actively recruiting
Study Goal
Evaluate visugromab in combination with standard-of-care chemoimmunotherapy versus chemoimmunotherapy alone as a first-line treatment for patients with newly diagnosed metastatic non-squamous non-small cell lung cancer.
NCT Number
NCT07098988
Indication
Non-squamous metastatic NSCLC
Treatment Line
1L
Status
Actively recruiting

Phase 2b

2b
Preclinical Phase 1 Phase 2 Phase 3
2b

The trial builds on proof-of-concept data from the GDFATHER Phase 1/2a program, where visugromab in combination with nivolumab demonstrated deep and durable responses in patients with advanced tumors that had progressed after prior anti-PD-(L)1 therapy, including an ORR of 18.2% in the non-squamous NSCLC cohort. CatalYm announced first patient dosing in September 2025.

GDFATHER-NSCLC-02

Non-squamous metastatic NSCLC

Actively recruiting
Study Goal
Evaluate visugromab and nivolumab, with or without docetaxel, versus docetaxel alone as a second-line treatment for patients with metastatic non-squamous NSCLC who have progressed following initial systemic treatment including an approved immune checkpoint inhibitor.
NCT Number
NCT07246863
Indication
Non-squamous metastatic NSCLC
Treatment Line
2L
Status
Actively recruiting

Phase 2b

2b
Preclinical Phase 1 Phase 2 Phase 3
2b

The trial builds on proof-of-concept data from the GDFATHER Phase 1/2a program, which demonstrated that visugromab in combination with nivolumab can generate deep and durable responses in patients with advanced solid tumors that progressed after prior anti-PD-(L)1 therapy, including an ORR of 18.2% in the non-squamous NSCLC cohort. CatalYm announced first patient dosing in December 2025.

GDFATHER-HCC-01

Hepatocellular carcinoma

Actively recruiting
Study Goal
Evaluate visugromab in combination with chemoimmunotherapy as a second-line treatment for patients with unresectable or metastatic hepatocellular carcinoma who have progressed following first-line anti-PD-(L)1-based therapy. The trial will assess visugromab with nivolumab and lenvatinib versus placebo plus lenvatinib.
NCT Number
NCT07219459
Indication
Hepatocellular carcinoma
Treatment Line
2L
Status
Actively recruiting

Phase 2b

2b
Preclinical Phase 1 Phase 2 Phase 3
2b

The trial builds on proof-of-concept data from the GDFATHER Phase 1/2a program, which demonstrated deep and durable responses with visugromab in combination with nivolumab in patients with advanced tumors that had progressed after prior anti-PD-(L)1 therapy, including a confirmed ORR of 14.3% in the HCC cohort. CatalYm announced first patient dosing in April 2026.

VINCIT

Cancer-associated cachexia

Actively recruiting
Study Goal
Evaluate visugromab versus placebo in patients with cachexia associated with advanced cancers, including non-small cell lung cancer, colorectal cancer and some other gastrointestinal tumors.
NCT Number
NCT07112196
Indication
Cancer cachexia
Treatment Line
1L+
Status
Actively recruiting

Phase 2/3

2/3
Preclinical Phase 1 Phase 2 Phase 3
2/3

VINCIT advances visugromab into Phase 2/3 development for cancer-associated cachexia, building on promising weight gain data from the GDFATHER Phase 1/2a trial in advanced solid tumors. CatalYm announced first patient dosing in April 2026.

GDFATHER-NEO

Muscle-invasive bladder cancer

Active, completed enrollment
Study Goal
Evaluate neoadjuvant visugromab in combination with nivolumab compared with nivolumab alone in cisplatin-ineligible or cisplatin-refusing patients with newly diagnosed muscle-invasive bladder cancer who are scheduled to undergo radical cystectomy or re-transurethral resection of the bladder tumor.
NCT Number
NCT06059547
Indication
Muscle-invasive bladder cancer
Treatment Line
Neoadjuvant
Status
Active, completed enrollment

Phase 2

2
Preclinical Phase 1 Phase 2 Phase 3
2

Primary proof-of-concept data from GDFATHER-NEO were presented at ESMO 2025, demonstrating a substantial increase in anti-tumor activity in the visugromab-nivolumab arm compared to nivolumab alone.

GDFATHER

Advanced solid tumors

Active, completed enrollment
Study Goal
Evaluate visugromab in combination with nivolumab in heavily pretreated patients with advanced solid tumors who had progressed after prior anti-PD-(L)1 treatment.
NCT Number
NCT04725474
Indications
Non-squamous NSCLC, UC, HCC and other solid tumors
Treatment Line
2L+
Status
Active, completed enrollment

Phase 1/2a

1/2a
Preclinical Phase 1 Phase 2 Phase 3
1/2a

Clinical proof-of-concept data were published in Nature in 2024, and long-term follow-up data were presented at ESMO 2025, demonstrating overall response rates of 18.2% in non-squamous NSCLC, 18.5% in UC and 14.3% in HCC as well as median duration of response that exceeded 32 months in non-squamous NSCLC, 28 months in UC and 19 months in HCC, with more than half of responses ongoing at data cut-off.

Our Clinical Trial Sites

Map showing CatalYm clinical trial sites
Actively recruiting Active, not recruiting Other sites
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