A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors

2024-519862-33-00 Protocol CUSP06-1001 Human pharmacology (Phase I) - First administration to humans Not authorised

Status Not authorised · 2 EU/EEA countries · 2 sites · Protocol CUSP06-1001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Not authorised
Participants planned 197
Countries 2
Sites 2

Platinum-resistant ovarian cancer (PROC)

Key facts

Sponsor
Oncusp Therapeutics Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2025-06-18
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-519862-33-00
ClinicalTrials.gov
NCT06234423

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Platinum-resistant ovarian cancer (PROC)

VersionLevelCodeTermSystem organ class
20.0 PT 10033128 Ovarian cancer 100000004864
25.0 LLT 10086821 Advanced renal cell carcinoma 100000004848

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oncusp Therapeutics Inc.

Sponsor organisation
Oncusp Therapeutics Inc.
Address
433 Broadway
City
New York
Postcode
10013-2510
Country
United States

Scientific contact point

Organisation
Oncusp Therapeutics Inc.
Contact name
Priya Marreddy

Public contact point

Organisation
Oncusp Therapeutics Inc.
Contact name
Priya Marreddy

Locations

2 EU/EEA countries · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Not authorised 10 1
Spain Not authorised 10 1
Rest of world
United Kingdom, United States
177

Investigational sites

Denmark

1 site · Not authorised
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe

Spain

1 site · Not authorised
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-03-11 Denmark Not acceptable
2025-06-18
2025-06-18