A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Clasp Therapeutics, Inc.
Study ID
NCT06778863
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • CLSP-1025 — DRUG
    CLSP-1025 will be administered by IV infusion

Study Details

Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.

Key Dates

First listed
Jan 16, 2025
Start date
Feb 28, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Part A: Monotherapy Dose Escalation of CLSP-1025
    Dose escalation of CLSP-1025 in HLA-A\*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation
  • Experimental: Part B: Monotherapy Dose Expansion of CLSP-1025
    Dose expansion of CLSP-1025 in HLA-A\*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation

Primary Outcome Measure

Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s]) [ Time Frame: 28 days after infusion ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
833-354-6667
The University of Arizona Cancer CenterTucsonArizona85719
USC - Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
[email protected]
323-865-0451
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
916-703-5558
University of California San FranciscoSan FranciscoCalifornia94143
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136
407-765-9589
The University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
855-403-0533
University of Kentucky Markey Cancer CenterLexingtonKentucky40536
859-257-4488
Johns Hopkins - Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
410-955-8964
Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
646-608-4042
NYU Langone HealthNew YorkNew York10016
212-263-4432
Duke Cancer InstituteDurhamNorth Carolina27701
866-385-3123
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
215-214-1515
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107
Aliya Rogers
[email protected]
Sarah Cannon Research Institute (SCRI) Oncology PartnersNashvilleTennessee37203
615-329-7640
Vanderbilt University Medical CenterNashvilleTennessee37232
615-936-8422
Baylor University Medical CenterDallasTexas75246
888-507-3732
Mary Crowley Cancer ResearchDallasTexas75230
972-566-3000
MD Anderson Cancer CenterHoustonTexas77030
888-989-5374
Fred Hutchinson Cancer CenterSeattleWashington98109
855-557-0555

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