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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must be at least 18 years of age at the time of signing the informed consent. - Patients must be willing and able to provide written informed consent - Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists - Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test - Patients must be HLA-A*02:01 positive by central assay - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment - 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 with Li-Fraumeni syndrome or other known germline p53 R175H mutation - Patients who have received other p53 R175H-directed therapies - Patients who have not fully recovered from adverse events due to previous anticancer therapies - Patients with active infection requiring systemic antimicrobial therapy - Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission. - Known active central nervous system metastases and/or carcinomatous meningitis

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: CLSP-1025
    CLSP-1025 will be administered by IV infusion
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
  • Drug: CLSP-1025
    CLSP-1025 will be administered by IV infusion

Recruiting Locations

HonorHealth Research Institute
Scottsdale 5313457, Arizona 5551752 85258
Contact:
833-354-6667

The University of Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85719
Contact:
UACC-ClinicalTrialsInfo@arizona.edu

USC - Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
Contact:
323-865-0451
clinical.trials@med.usc.edu

University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817
Contact:
916-703-5558

University of California San Francisco
San Francisco 5391959, California 5332921 94143
Contact:
hdfccc.cip@ucsf.edu

University of Miami - Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136
Contact:
407-765-9589

The University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861 60637
Contact:
855-403-0533

University of Kentucky Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
Contact:
859-257-4488

Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21287
Contact:
410-955-8964

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Oncology Clinical Research Referral Office
551-996-1777
OncologyResearchReferral@hmhn.org

NYU Langone Health
New York 5128581, New York 5128638 10016
Contact:
212-263-4432

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
646-608-4042

Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27701
Contact:
866-385-3123

Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Aliya Rogers
axr028@jefferson.edu

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111
Contact:
215-214-1515

Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
Contact:
615-329-7640

Mary Crowley Cancer Research
Dallas 4684888, Texas 4736286 75230
Contact:
972-566-3000

Baylor University Medical Center
Dallas 4684888, Texas 4736286 75246
Contact:
888-507-3732

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
888-989-5374

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109
Contact:
855-557-0555

More Details

NCT ID
NCT06778863
Status
Recruiting
Sponsor
Clasp Therapeutics, Inc.

Study Contact

Lauren Harshman, MD
+1-617-812-1431
LHarshman@clasptx.com

Detailed Description

This Phase 1, open-label, multicenter study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of CLSP-1025 when administered to HLA-A*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation. The study will be conducted in 2 parts: Part A Monotherapy Dose Escalation to determine the recommended dose(s) for expansion (RDE[s]) and Part B Monotherapy Expansion to explore the preliminary antitumor activity as well as further characterize the safety, tolerability, PK, and PD of CLSP-1025 at the RDE(s).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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