Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
Research type
Research Study
Full title
A Dose Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 as a single agent and combination therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
IRAS ID
1005594
Contact name
Karen Hodsdon
Contact email
Sponsor organisation
Exelixis, Inc
Eudract number
2021-006543-10
Clinicaltrials.gov Identifier
Research summary
XB002 is an intravenous, investigational anti-cancer agent that is being studied in people for the first time. The goal of this early study is to learn about the effects of XB002 alone and in combination therapy by testing its safety, ability of the body to accept study treatment, measure XB002 and/or its break-down products levels in the blood, and how the body and cancer react to the drug. Patients enrolled in the cohort expansion stage will receive XB002 at the recommended safe dose, found in the first stage of this study, or will receive XB002 in combination with nivolumab. The purpose of the cohort expansion stage is to find out whether study treatment is effective in treating non-squamous non-small cell lung cancer, ovarian cancer, cervical cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, urothelial cancer, esophageal squamous cell carcinoma, metastatic castration-resistant prostate cancer, triple-negative breast cancer and HR positive breast cancer. Before taking part in this study, patients will complete their screening tests to determine if they are eligible to participate in the study. The duration of participation in this study will depend on the ability to safely tolerate the treatment, the response to treatment and on the patient and doctor’s decision to continue treatment. Patients will be on treatment for about 4-6 months, but it is possible to receive treatment for up to 24 months. XB002 can be continued for more than 24 months if it is determined that a patient is receiving clear clinical benefit. There are required tests and procedures for all patients on this study; some are part of the routine care of patients with cancer, though they may be conducted more often because this is a research study, and some are for research purposes only.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0404
Date of REC Opinion
20 Jan 2023
REC opinion
Further Information Favourable Opinion