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

Summary

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.

Interventions

• CLSP-5282 · DRUG

  CLSP-5282 to be administered by IV infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (4)

• Duke Cancer Institute, Durham, North Carolina
• Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania
• Sarah Cannon Research Institute (SCRI) Oncology Partners, Nashville, Tennessee
• Mary Crowley Cancer Research, Dallas, Texas