A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1
- Status
- Not yet recruiting
- Start
- 2026-07
- End
- 2029-07
- Enrollment
- 140
- Sites
- 4
- Sponsor class
- INDUSTRY
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Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Detailed description · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: CLSP-5282. CLSP-5282 to be administered by IV infusion
Arm · public domain (ClinicalTrials.gov) · T1
Part A Monotherapy Dose Escalation (experimental): Dose Escalation of CLSP-5282 in HLA A\*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
Arm · public domain (ClinicalTrials.gov) · T1
Part B Monotherapy Expansion (experimental): Dose expansion of CLSP-5282 in 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 conducted at the RDE.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Part A Monotherapy Dose Escalation. To characterize the safety and tolerability of CLSP-5282 and to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE\[s\]). Time frame: 28 days after infusion.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Part B Monotherapy Expansion. To evaluate the preliminary antitumor activity of CLSP-5282 Time frame: Up to 24 months after infusion.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0. Time frame: Up to 30 days after last infusion.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0. Time frame: Up to 30 days after last infusion.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Determine Maximum Plasma Concentration of CLSP-5282. Time frame: Pre-dose and up to 168 hours post-dose.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Half-life (t1/2) of CLSP-5282. Time frame: Pre-dose and up to 168 hours post-dose.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Assess the immunogenicity of CLSP-5282. Time frame: Up to 24 months after infusion.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Part A: Objective Response Rate (ORR). Time frame: Up to 24 months after infusion.
Eligibility · public domain (ClinicalTrials.gov) · T1
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
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 140 participants (estimated).