Study of CUSP06 in Pts With Platinum-Refractory/Resistant Ovarian Cancer and Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1, First-in-Human Study of CUSP06, a Cadherin-6 (CDH6)-directed Antibody-Drug Conjugate, in Patients with Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
IRAS ID
1011303
Contact name
Priya Marreddy
Contact email
Sponsor organisation
OnCusp Therapeutics
Eudract number
2024-519862-33
Clinicaltrials.gov Identifier
Research summary
This study will test an investigational medication called CUSP06. CUSP06 is being tested to see if it can help patients with advanced or aggressive cancers that affect different organs, including the ovaries, kidneys, bile ducts, uterus, and thyroid. Despite standard treatment options (e.g., chemotherapy or immunotherapy [increasing the body’s natural defenses against cancer]), these cancers remain challenging to treat, meaning there is a need for more effective treatments.
This study will try to find out:
- How safe CUSP06 drug is, i.e., what side effects CUSP06 causes and how bad they are.
- If CUSP06 works, i.e., if CUSP06 can slow down cancer growth and fight cancer cells in the body.
- What the body does to CUSP06 i.e., how the body breaks down CUSP06, and how long CUSP06 stays in the body.
- How the immune system responds to CUSP06, i.e., if the body tries to fight off study drug in the same way it fights off infections.
This is an open-label study. Participants will start in one of 2 study parts (1a or 1b) based on the study’s current stage at the time they join. Each study part has 4 periods: Screening period, treatment period, safety follow-up visit and long-term follow-up.
CUSP06 will be administered as intravenous infusion. Some participants may also receive a prophylactic dose of an approved medication G-CSF (administered as an injection below the skin or an IV infusion) to reduce their chance of developing low white cell levels.
Only participants ≥18 years of age who are able and willing to provide written informed consent can take part. The study will include participants with advanced cancers who have already received standard therapy or for whom no standard therapy is available.
Study procedures include blood draws, blood pressure, pulse, temperature, their heart rhythm, and perform a heart ultrasound and if archival tissue is not available, then a fresh tissue biopsy will be taken.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0085
Date of REC Opinion
12 Jun 2025
REC opinion
Further Information Unfavourable Opinion