CLSP-1025 for Solid Tumors with p53 R175H Mutation

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

Recruiting Phase 1 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Clasp Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for adult patients with specific advanced solid tumors that have not responded to standard treatments. Participants will receive the treatment CLSP-1025 and attend regular study visits while following the study protocol.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I can provide written informed consent.
  • I have advanced or metastatic solid tumors that have worsened after standard treatment or have no standard treatment available.
  • My tumors have a TP53 R175H mutation confirmed by a lab test.
  • I am HLA-A*02:01 positive.
  • I have an ECOG performance status of 0 to 1.
  • I have adequate blood, kidney, and liver function.
  • I can complete study visits and follow study requirements.

You may not be able to join if

  • I have Li-Fraumeni syndrome or another known germline p53 R175H mutation.
  • I have received other therapies targeting p53 R175H.
  • I have not fully recovered from side effects of prior cancer treatments.
  • I have an active infection that needs systemic antibiotic treatment.
  • I have another primary cancer diagnosed within the last 2 years, except for some types of skin cancer or previous prostate cancer in remission.
  • I have known active brain metastases or carcinomatous meningitis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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 thera…
Contacts

Lauren Harshman, MD

+1-617-812-1431

LHarshman@clasptx.com

CONTACT