Phase I study of PM534 to patients with advanced solid tumors

ISRCTN	ISRCTN97337444
DOI	https://doi.org/10.1186/ISRCTN97337444
Clinical Trials Information System (CTIS)	2024-519013-57-00
Integrated Research Application System (IRAS)	1011534
Protocol number	PM534-A-002-24
Sponsor	PharmaMar (Spain)
Funder	PharmaMar

Submission date: 14/05/2026
Registration date: 20/05/2026
Last edited: 20/05/2026

Recruitment status: Recruiting
Overall study status: Deferred
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date

Contact information

Pharma Mar S.A. Clinical Development Oncology Unit
Public

Avenida De Los Reyes 1
Poligono Industrial La Mina
Colmenar Viejo, Madrid
28770
Spain

Phone	+34918466000
Email	clinicaltrials@pharmamar.com

Pharma Mar S.A. Clinical Development Oncology Unit
Scientific

Avenida De Los Reyes 1
Poligono Industrial La Mina
Colmenar Viejo, Madrid
28770
Spain

Phone	+34 918466000
Email	clinicaltrials@pharmamar.com

Dr Martin Forster
Principal investigator

University College Hospital
250 Euston Road
London
NW1 2PG
Spain

Phone	+44 2034479091
Email	m.forster@ucl.ac.uk

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	To identify the dose-limiting toxicities (DLTs), and to determine the maximum tolerated dose (MTD) and the recommended dose (RD) and to evaluate the antitumor activity in solid tumors
Scientific title	The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Study acronym	PM534A2
Study objectives	The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Ethics approval(s)	Approved 22/10/2025, East of England - Cambridgeshire and Hertfordshire (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 020 7104 8096; cambsandherts.rec@hra.nhs.uk), ref: 25/EE/0192
Health condition(s) or problem(s) studied	The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Intervention	The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Primary outcome measure(s)	[Outcome name] measured using [Metric or method of measurement] at [Timepoint(s)] The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Key secondary outcome measure(s)
Completion date	08/08/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	15
Key inclusion criteria	The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Key exclusion criteria	The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.
Date of first enrolment	10/04/2026
Date of final enrolment	30/07/2027

Locations

Countries of recruitment

United Kingdom
England
Spain

Study participating centre

University College London Hospitals NHS Foundation Trust

250 Euston Road
London
NW1 2PG
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

15/05/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).