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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Clasp Therapeutics, Inc.
Study ID
NCT07650357
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLSP-5282 — DRUG
    CLSP-5282 to be administered by IV infusion

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Monotherapy Dose Escalation
    Dose Escalation of CLSP-5282 in HLA A\*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
  • Experimental: Part B Monotherapy Expansion
    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 Measure

Part A Monotherapy Dose Escalation [ Time Frame: 28 days after infusion ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27701-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107
Aliya Rogers
[email protected]
Sarah Cannon Research Institute (SCRI) Oncology PartnersNashvilleTennessee37203
615-329-7640
Mary Crowley Cancer ResearchDallasTexas75230
972-566-3000

Find similar trials in Durham, NC

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By specialty
OncologyGI oncologyLung oncologyLung disease
By research site
Duke Cancer Institute· Durham, NCThomas Jefferson University, Sidney Kimmel Cancer Center· Philadelphia, PASarah Cannon Research Institute (SCRI) Oncology Partners· Nashville, TNMary Crowley Cancer Research· Dallas, TX

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