Open-label, long-term extension study of lerociclib (EQ132)
Research type
Research Study
Full title
An Open-Label, Long-Term Extension Study of Lerociclib (EQ132) in Participants with Advanced/Metastatic or Recurrent Solid Tumors.
IRAS ID
1008169
Contact name
Wheatley Spence
Contact email
Sponsor organisation
EQRx International, Inc.
Research summary
The primary purpose of this study is to enable participants who have advanced/metastatic or recurrent solid tumours, predominantly breast or endometrial cancer and who are actively receiving lerociclib in a qualifying parent clinical study to continue receiving treatment with lerociclib after the parent study has ended. Lerociclib is a drug that blocks proteins called cyclin-dependent kinases (CDK) 4 and 6, which allow cancer cells to divide and multiply. Drugs like lerociclib that block CDK4 and CDK6 may stop a tumour from growing for months or even years. It is given in combination with hormone therapies (fulvestrant with or without goserelin and letrozole), meaning drugs that block, or decrease hormone activity which also slow the growth or development of cancer. It is thought that combining these drugs is more effective than hormonal therapy alone. Fulvestrant with or without goserelin is for patients with breast cancer and letrozole predominantly for patients with endometrial cancer. This study will evaluate the long-term safety and long-term outcomes in participants. Participants in this long-term extension study will continue to receive lerociclib and endocrine therapy at the same dose and frequency as in the parent study, at the dose level at which they have been stable. Lerociclib is administered orally in a tablet form. Assessments and investigations will mostly follow standard of care practice and study specific activities will be minimal.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0540
Date of REC Opinion
27 Sep 2023
REC opinion
Further Information Unfavourable Opinion