A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
Sponsored by Clasp Therapeutics, Inc.
About this study
Phase 1, open-label, multicenter study 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.
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 …
Where this study is enrolling (3)
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Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania
- Call 615-329-7640
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee
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- Call 972-566-3000
Mary Crowley Cancer Research
Dallas, Texas
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Who can participate
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
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Trial data sourced from ClinicalTrials.gov.