A Phase 1/2 Study of Pumitamig alone or in Combination with Ipilimumab in First-Line HCC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 May 2026 → ongoing

Decision date (initial)

2026-04-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-523602-33-00

WHO UTN

U1111-1327-4912

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Safety, Efficacy, Dose response

The main goal of phase 1 is to see if it is safe for people with liver cancer to take pumitamig with ipilimumab, and to find the best dose to use, while the main goal of phase 2 is to see which treatment works better at shrinking liver cancer: pumitamig with ipilimumab, pumitamig alone, or atezolizumab with bevacizumab.

Secondary objectives 1

1. Secondary goals are to check how safe the treatments are, how the body handles the medicine, if the body fights against the medicine, and how well each treatment works for liver cancer.

Conditions and MedDRA coding

Advanced or unresectable Hepatocellular Carcinoma (HCC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age of Participant must be ≥ 18 years of age, or legal adult age according to the local regulation inclusive, at the time of signing the ICF.
2. People with a certain kind of advanced liver cancer (HCC) that can't be removed by surgery.
3. People who can still do most everyday things on their own.
4. People whose liver is working well.
5. People who haven't had certain treatments for their liver cancer before.
6. People who have at least one tumor that shows up on a scan.

Exclusion criteria 6

1. People with rare types of liver cancer.
2. People who have serious bleeding problems or are likely to bleed easily.
3. People who have had an organ transplant or have immune system diseases.
4. People with high blood pressure that can’t be controlled, even with medicine.
5. People whose urine has too much protein (sign of kidney problems).
6. People taking strong blood-thinning medicines.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The main goal of phase 1 will check and count for how many people have problems or serious problems from the medicine, if anyone must stop taking it because of these problems, and if any problems cause death.
2. The main goal of phase 2 will be to check and count how many people's liver cancer gets much smaller or completely goes away with the treatment (OR (Objective Response) confirmed CR (complete response) or PR (partial response)).

Secondary endpoints 6

1. To check how many people’s liver cancer gets much smaller or goes away (cancer shrinkage).
2. To count how many people have problems or serious problems from the medicines, including those who stop treatment or die because of them (safety)
3. To measure how much pumitamig is in the blood after treatment and before the next dose (pumitamig levels).
4. To measure how much ipilimumab is in the blood before the next dose (ipilimumab levels).
5. To see if people’s bodies make fighters against the medicines (anti-drug antibodies).
6. To see how long people live without the cancer getting worse, and how long the cancer stays smaller or goes away (progression delay (PFS, Progression-Free Survival and duration (DOR, Duration of Response).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 6

Locations

5 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications