XMT-1536 In Patients with Solid Tumours
Research type
Research Study
Full title
A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b
IRAS ID
273531
Contact name
Susana Banerjee
Contact email
Sponsor organisation
Mersana Therapeutics Inc.,
Eudract number
2020-000630-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
XMT-1536 is an investigational drug and not approved as a treatment for cancer. XMT-1536 is a type of antibody drug conjugate (2 parts joined together into one drug). The first part is an antibody that binds to NaPi2b (sodium-dependent phosphate transporter), a protein on the surface of the cells of the tumour. The second part is a cancer medicine attached to the antibody. When the antibody binds to NaPi2b, it carries the cancer medicine directly into the tumour cells to kill them. Patients may take part in this study if they have been diagnosed with a NAPi2b expressing cancers and no other therapy has worked/stopped working.
This is a Phase 1b study and the first time that people have received XMT-1536. This study has two parts; dose escalation (DES) and dose expansion (EXP). DES tested different and increasing doses of XMT-1536 (3 patients per group) to determine the recommended maximum dose (that has tolerable side effects). DES is now complete and the maximum tolerable dose is 43 mg/m2. EXP, will further study this recommended dose from DES in patients with ovarian and non-small cell lung cancer. During EXP, the study doctors will review clinical safety data at least quarterly. It is possible that the Safety Review Committee will recommend increasing the expansion dose based on what it learned in the DES. This study looks at how well the study drug is tolerated by the body, what the body does to the study drug and how the study drug affects the body. Patients will undergo physical exams, vital signs, blood/urine sampling, tumour scans, biopsies, eye and heart examinations and other assessments.
Sixty-two patients were dosed (DES) from 7 centres in the US and approximately 120 patient (EXP) will be dosed from 40 centres globally. Patients may continue in the study if they are benefitting.REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/1158
Date of REC Opinion
1 Dec 2020
REC opinion
Further Information Favourable Opinion