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 1Interventional Study
Advanced Solid TumorUnresectable Solid TumorMetastatic Solid TumorColorectal AdenocarcinomaPancreatic AdenocarcinomaLung CancerOvarian CancerBreast CancerHead and Neck Squamous Cell CarcinomaProstate CancerBladder 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.