A Phase 1a/1b Study of LY4052031 in Participants with Solid Tumors
Research type
Research Study
Full title
A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants with Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors
IRAS ID
1010148
Contact name
Yolanda Villalobos
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
Nectin-4 is a protein that is widely expressed in several tumours and is shown to contribute to tumour cell growth. Nectin-4 is expressed in more than 80% of bladder cancers and in at least 50% of breast, ovarian, oesophageal, pancreatic, and cervical cancers, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinomas (HNSCC). These tumours, once relapsed, are considered incurable and represent diseases with high unmet medical need, particularly in the advanced setting.
The drug called enfortumab vedotin, which targets Nectin-4, has been approved in several countries for the treatment of advanced bladder cancer, but it is associated with important side effects that limit its use, including skin toxicity and peripheral neuropathy. Enfortumab vedotin is administered weekly and to date, it has not been shown to be effective in other cancer types.
LY4052031 is an investigational drug designed to treat solid cancers that are likely to have the protein, Nectin-4, on the cancer cells. It is structurally different from enfortumab vedotin. This study will be the first time LY4052031 will be given to humans and the main goal is to evaluate safety and identify the optimal dose of LY4052031 for cancer patients. In pre-clinical animal studies LY4052031 is well-tolerated and has shown antitumor activity. This study will evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of LY4052031 in selected tumour types including bladder cancer, oesophageal cancer, pancreatic cancer, triple negative breast cancer (TNBC), NSCLC, ovarian cancer, cervical cancer, HNSCC, and prostate cancer. The participants will receive LY4052031 as an infusion into an arm vein or via a port-a-cath, once every 21 days or 3 weeks.
About 220 people in total will take part in this entire research study in about 25 centres within North America, Europe, Australia, and Asia.
The Sponsor of the study is Loxo Oncology, Inc. on behalf of Eli Lilly and Company.REC name
North West - Haydock Research Ethics Committee
REC reference
24/NW/0216
Date of REC Opinion
1 Aug 2024
REC opinion
Further Information Favourable Opinion