A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)

CLSP-5282-101 is a Phase 1, open-label, multicenter study designed to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP-5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.

The study will be conducted in 2 parts:

Part A Monotherapy Dose Escalation to determine the MTD and/or RDE(s) to characterize safety and clinical activity of CLSP-5282.

Part B Monotherapy Expansion to explore the preliminary antitumor activity and further characterize the safety, tolerability, PK, and PD of CLSP-5282 at the RDE(s). Part B will include three indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort.

Inclusion criteria

• Adults at least 18 years of age on the day of signing informed consent.
• Willing and able to provide written informed consent for the study.
• Histologically or cytologically diagnosed, locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.
• Tumors must harbor the KRas G12V mutation confirmed by the site's local or preferred tissue or ctDNA testing platform in an accredited laboratory.
• Patients must be HLA-A*03:01 positive by central assay.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Adequate hematological, renal and hepatic function.
• Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation.

Exclusion criteria

• Patients who have received other KRas G12V directed cellular therapies or TCEs.
• Patients may not be on other anticancer therapies at the time of the first dose of CLSP-5282. Exceptions upon agreement with Sponsor.
• Any other primary malignancy within the 2 years prior to first dose of study treatment except for non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or prostate cancer in remission.
• Patients who have not fully recovered from adverse events due to previous anticancer therapies
• Patients with active infection requiring systemic antimicrobial therapy
• Known primary malignant brain tumors, active central nervous system metastases and/or carcinomatous meningitis