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Not yet recruiting NCT07650357

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

Phase I Interventional Advanced Solid Tumor Non Small Cell Lung Cancer Pancreatic Carcinoma Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CLSP-5282.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Non Small Cell Lung Cancer, Pancreatic Carcinoma, Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SENTINEL-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors That Harbor the KRas G12V Mutation

Overview

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

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.

Interventions

  • Drug CLSP-5282
    CLSP-5282 to be administered by IV infusion

Primary outcome measures

  • Part A Monotherapy Dose Escalation [Time frame: 28 days after infusion]
  • Part B Monotherapy Expansion [Time frame: Up to 24 months after infusion]
Secondary outcome measures (12)
  • Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0 [Time frame: Up to 30 days after last infusion]
  • Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0 [Time frame: Up to 30 days after last infusion]
  • Determine Maximum Plasma Concentration of CLSP-5282 [Time frame: Pre-dose and up to 168 hours post-dose]
  • Half-life (t1/2) of CLSP-5282 [Time frame: Pre-dose and up to 168 hours post-dose]
  • Assess the immunogenicity of CLSP-5282 [Time frame: Up to 24 months after infusion]
  • Part A: Objective Response Rate (ORR) [Time frame: Up to 24 months after infusion]
  • Duration of response (DOR) [Time frame: Up to 24 months after infusion]
  • Time to Response [Time frame: Up to 24 months after infusion]
  • Disease Control Rate [Time frame: Up to 24 months after infusion]
  • Progression-free survival (PFS) [Time frame: Up to 24 months after infusion]
  • Time on Treatment [Time frame: Up to 24 months after infusion]
  • Overall Survival (OS) [Time frame: Up to 24 months after infusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Duke Cancer Institute — Durham
  • Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia
  • Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville
  • Mary Crowley Cancer Research — Dallas

Identifiers

NCT: NCT07650357 · CLSP-5282-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗