A Phase 1 open-label, first-in-human, multi-center, dose escalation and dose expansion study of CLN-619 administered alone or in combination with pembrolizumab in patients with advanced solid tumors.

Start 27 Jun 2022 · End 30 Dec 2025 · Status Ended · 2 EU/EEA countries · 8 sites · Protocol CLN-619-001

Overview

Sponsor-declared trial summary

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

Status Ended

Participants planned 400

Countries 2

Sites 8

Solid tumors, Non-Small Cell Lung Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, breast cancer, gastrointestinal cancer

Key facts

Sponsor: Cullinan Mica Corp.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 27 Jun 2022 → 30 Dec 2025
Decision date (initial): 2024-03-29
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-511744-27-00
EudraCT number: 2021-002473-26
ClinicalTrials.gov: NCT05117476

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Solid tumors, Non-Small Cell Lung Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, breast cancer, gastrointestinal cancer

Version	Level	Code	Term	System organ class
20.0	PT	10033128	Ovarian cancer	100000004864
21.1	LLT	10008229	Cervical cancer	10029104
21.0	LLT	10049280	Solid tumour	10029104
20.0	PT	10006187	Breast cancer	100000004864
21.0	PT	10014733	Endometrial cancer	100000004864
21.0	PT	10061451	Colorectal cancer	100000004864
21.0	LLT	10015362	Esophageal cancer	10029104
21.1	PT	10017758	Gastric cancer	100000004864
21.1	PT	10061873	Non-small cell lung cancer	100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cullinan Mica Corp.

Sponsor organisation: Cullinan Mica Corp.
Address: 1 Main Street Suite 1350
City: Cambridge
Postcode: 02142-1531
Country: United States

Scientific contact point

Organisation: Cullinan Mica Corp.
Contact name: Study Responsible Physician

Public contact point

Organisation: Cullinan Mica Corp.
Contact name: Study Responsible Physician

Locations

2 EU/EEA countries · 8 investigational sites

By country

Country	MS status	Planned subjects	Sites
Poland	Ended	120	3
Spain	Ended	120	5
Rest of world United States, Australia	—	160	—

Investigational sites

Poland

3 sites · Ended

Med Polonia Sp. z o.o.

N/A, Obornicka 262, 60-693, Poznan

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Early Phase Research Division, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Biokinetica S.A.

N/A, Ul. Nadwislanska 37, 05-410, Jozefow

Spain

5 sites · Ended

Complejo Hospitalario Universitario Insular Materno Infantil

Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria

Clinica Universidad De Navarra

Oncology, Avenue Pio XII 36, 31008, Pamplona

Hospital Universitario Fundacion Jimenez Diaz

Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital Hm Nou Delfos

Oncology, Avinguda De Vallcarca 151, 08023, Barcelona