RecruitingPhase 1

A Study of CLSP-1025 in Adult Patients With 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 1 study tests different doses of CLSP-1025, a drug designed to help immune cells target cancer. It is for adults with solid tumors that have a gene change called p53 R175H and an immune system marker called HLA-A*02:01.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old when signing the consent form.
  • Be willing and able to give written consent to join.
  • Have a solid tumor that has spread nearby or to other parts of the body and has worsened after standard treatment, or has no standard treatment.
  • Have a tumor with the TP53 R175H gene change, confirmed by an approved lab test.
  • Test positive for the HLA-A*02:01 immune system marker through the study's central lab.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have blood counts, kidney function, and liver function that meet study requirements.
  • Be willing and able to follow study rules and complete visits and tests, as judged by the study doctor.

Who can't join

  • Have Li-Fraumeni syndrome, an inherited condition that raises cancer risk, or another known inherited p53 R175H gene change.
  • Have received another treatment aimed at p53 R175H.
  • Have not fully recovered from side effects of past cancer treatments.
  • Have an active infection that needs medicine that works throughout the body.
  • Have had another separate cancer in the past 2 years, except non-melanoma skin cancer, cancer limited to where it started, or prostate cancer in remission.
  • Have known active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key 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 Key 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 sites (21)

AZ

CA

FL

IL

KY

MD

NC

NJ

NY

PA

TN

TX

WA