PROCLAIM CX-2009 in adults with metastatic/advanced solid tumours
Research type
Research Study
Full title
A Phase 1-2, Open-Label, Dose-Finding, Proof Of Concept, First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of CX-2009 In Adults With Metastatic Or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)
IRAS ID
228055
Contact name
Hendrik-Tobias Arkenau
Contact email
Sponsor organisation
CytomX Therapeutics, Inc
Eudract number
2017-000625-12
Clinicaltrials.gov Identifier
EudraCT no, 2017-000625-12; IND Number, 130533; NCT, NCT03149549
Duration of Study in the UK
3 years, 7 months, 22 days
Research summary
CytomX Therapeutics, Inc. have developed a new antibody based cancer medication, CX-2009. CX-2009 is a masked antibody which is attached to a cancer killing medication (DM4). The antibody recognises an antigen (marker on cells) called CD166. CD166 is common on many cell types but is also highly expressed in tumour cells. CX-2009 is designed to be tumour specific as the antibody has a mask that is only removed by proteins within the tumour environment, but not in the rest of the body. Once CX-2009 is in the tumour, the mask is removed and the antibody is able to bind to CD166 on cells in the tumour. Once the antibody binds to the tumour cells, it will deliver the cancer killing therapy, DM4. Breast, prostate, non-small cell lung, ovarian, endometrial, head and neck, and bile duct cancer have been selected for this study for their known high levels of CD166 expression.
The first part of the study will determine the safety and maximum tolerated dose (MTD) of CX-2009. The first subject in each dose cohort will be dosed at least 24 hours prior to any other subjects in that cohort being dosed, to allow for observation of possible severe and/or serious acute (IE: infusion-related) toxicities. Patients in each dose cohort will be assessed for 21 days after their first dose for occurrence of dose limiting toxicities (DLT). If no DLT occur, enrolment will continue at the next highest dose. Incrementally higher doses will be assessed until a maximum tolerated dose is defined or the highest dose (6mg/kg) has been tested and deemed safe, whichever is lower. If a MTD is not reached, the study guidelines have set the highest dose to be administered at 6mg/kg.
The second part of the study will be looking at giving participants, the maximum tolerable dose to see if they have a response to the treatment. There will be 14 subjects enrolled in each of the 7 selected tumour types.
Participants will receive an intravenous infusion of CX-2009 every 21 days without any other cancer treatment.REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0491
Date of REC Opinion
30 Jan 2018
REC opinion
Further Information Favourable Opinion