A Phase 1 Study of JNJ-89862175, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 Antibody Drug Conjugate, for Advanced Solid Tumors.

Start 16 Dec 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol 89862175LUC1001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ongoing, recruiting

Participants planned 360

Countries 1

Sites 2

Advanced Solid Tumors

Key facts

Sponsor: Janssen Cilag International
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 16 Dec 2025 → ongoing
Decision date (initial): 2025-11-21
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Advanced Solid Tumors

Version	Level	Code	Term	System organ class
21.1	LLT	10065252	Solid tumor	10029104

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation: Janssen Cilag International
Address: Turnhoutseweg 30
City: Beerse
Postcode: 2340
Country: Belgium

Scientific contact point

Organisation: Janssen Cilag International
Contact name: CTIS Point of Contact

Public contact point

Organisation: Janssen Cilag International
Contact name: CTIS Point of Contact

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	120	2
Rest of world Korea, Republic of, United States	—	240	—

Investigational sites

France

2 sites · Ongoing, recruiting

Institut Gustave Roussy

Drug Development Department (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif

Centre Leon Berard

Department of medical oncology, 28 Rue Laennec, 69008, Lyon

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
France	2025-12-16		2026-01-05

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-09-04	France	Acceptable 2025-11-13	2025-11-21
2	SUBSTANTIAL MODIFICATION	SM-1	2026-01-16	France	Acceptable 2026-03-12	2026-03-12