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Study of CLSP-1025 for Advanced Solid Tumors with p53 R175H Mutation

This study is testing a new treatment called CLSP-1025 for adults with advanced solid tumors that have a specific genetic change called the p53 R175H mutation. This includes cancers like colorectal and pancreatic adenocarcinoma. CLSP-1025 is given through an IV. The first part of the study will help doctors find the best dose of CLSP-1025. The second part will then look at how well CLSP-1025 shrinks tumors (objective response rate) in patients whose tumors have this specific mutation and who also have a certain immune system marker (HLA-A*02:01). To join, your tumor must have progressed after standard treatments or have no standard treatment options, and you must be at least 18 years old.

Study design
This is an open-label, multi-center study with an estimated 90 participants. It has two parts: one to find the right dose and another to further evaluate the treatment's effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate how well the treatment works for up to 24 months after the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06778863

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Clasp Therapeutics, Inc.
~90 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:CLSP-1025

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s])
Measured over 28 days after infusion
+1 more outcome measured

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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Bladder CarcinomaBreast CarcinomaColorectal AdenocarcinomaHead and Neck Squamous Cell CarcinomaLung CarcinomaMalignant Ovarian NeoplasmPancreatic AdenocarcinomaProstate CarcinomaSolid NeoplasmHLA Class I Histocompatibility Antigen, A-0201 Alpha ChainTP53 Gene

Where it's being run

21 sites across 13 states
California3
Texas3
Arizona2
New York2
Pennsylvania2
Tennessee2
Florida1
Illinois1

Who to contact

Lauren Harshman, MD
[email protected]
+1-617-812-1431
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s])28 days after infusion

    Rate of dose-limiting toxicities (DLTs) after infusion of CLSP-1025

  • Part B: Evaluate the Objective response rate (ORR) of CLSP-1025 as a monotherapy in HLA-selected patients with advanced solid tumors that express the p53 R175H mutationUp to 24 months after infusion

    Objective response rate (ORR) per RECIST V1.1 determined by Investigator assessment