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

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

  • Advanced Solid Tumor
  • Unresectable Solid Tumor
  • Metastatic Solid Tumor
  • Colorectal Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Lung Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Prostate Cancer
  • Bladder Cancer

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, Arizona 85258
Contact:
833-354-6667

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

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

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

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

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

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

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

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

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).

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center