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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Clasp Therapeutics, Inc.,

Study Record Dates

2028-06