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

NCT07650357 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CLSP-5282-101
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Advanced Solid Tumor; Non Small Cell Lung Cancer; Pancreatic Carcinoma; Colorectal Cancer

Keywords

T-Cell Engager; TCE; Clasp-5282; KRas G12V mutation; HLA A*03:01

Outcome Measures

Primary Outcomes (2)

• 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\[s\]).

  28 days after infusion

• Part B Monotherapy Expansion

  To evaluate the preliminary antitumor activity of CLSP-5282

  Up to 24 months after infusion

Secondary Outcomes (12)

• Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0

  Up to 30 days after last infusion

• Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0

  Up to 30 days after last infusion

• Determine Maximum Plasma Concentration of CLSP-5282

  Pre-dose and up to 168 hours post-dose

• Half-life (t1/2) of CLSP-5282

  Pre-dose and up to 168 hours post-dose

• Assess the immunogenicity of CLSP-5282

  Up to 24 months after infusion

Study Arms (2)

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.

Drug: CLSP-5282

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.

Drug: CLSP-5282

Interventions

CLSP-5282 DRUG

CLSP-5282 to be administered by IV infusion

Part A Monotherapy Dose Escalation; Part B Monotherapy Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clasp Therapeutics, Inc.: lead

Study Sites (4)

Duke Cancer Institute

Durham, North Carolina, 27701, United States

Location

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lauren Harshman, MD

  Clasp Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Lauren Harshman, MD

CONTACT

+1-617-812-1431; LHarshman@clasptx.com

Lauren Harshman

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)