Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

Details

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).

Keywords

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, CLSP-1025, T Cell Engager, TCE, TP53, Neoplasms, Adenocarcinoma, Squamous Cell Carcinoma of Head and Neck

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • USC - Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clasp Therapeutics, Inc.
ID
NCT06778863
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated