A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CLSP-1025.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Colorectal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Detailed description
This Phase 1, open-label, multicenter study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of CLSP-1025 when administered to HLA-A\*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation. The study will be conducted in 2 parts: Part A Monotherapy Dose Escalation to determine the recommended dose(s) for expansion (RDE\[s\]) and Part B Monotherapy Expansion to explore the preliminary antitumor activity as well as further characterize the safety, tolerability, PK, and PD of CLSP-1025 at the RDE(s).
Interventions
- Drug CLSP-1025
CLSP-1025 will be administered by IV infusion
Primary outcome measures
- Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s]) [Time frame: 28 days after infusion]
- 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 mutation [Time frame: Up to 24 months after infusion]
Secondary outcome measures (12)
- Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0 [Time frame: Up to 24 months after infusion]
- Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0 [Time frame: Up to 24 months after infusion]
- Number of patients with clinically significant changes in QTcF Interval [Time frame: Up to 24 months after infusion]
- Maximum plasma concentration (Cmax) of CLSP-1025 [Time frame: Pre-dose and up to 168 hours post-dose]
- Minimum plasma concentration (Cmin) of CLSP-1025 [Time frame: Pre-dose and up to 168 hours post-dose]
- Area under the curve at the end of the dosing interval (AUCtau) of CLSP-1025 [Time frame: Pre-dose and up to 168 hours post-dose]
- Half-life (t1/2) of CLSP-1025 [Time frame: Pre-dose and up to 168 hours post-dose]
- Assess the immunogenicity of CLSP-1025 [Time frame: Up to 24 months after infusion]
- Part A: Objective Response Rate (ORR) [Time frame: Up to 24 months after infusion]
- Duration of response (DOR) [Time frame: Up to 24 months after infusion]
- Time to Response [Time frame: Up to 24 months after infusion]
- Disease Control Rate [Time frame: Up to 24 months after infusion]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- HonorHealth Research Institute — Scottsdale
- The University of Arizona Cancer Center — Tucson
- USC - Norris Comprehensive Cancer Center — Los Angeles
- University of California Davis Comprehensive Cancer Center — Sacramento
- University of California San Francisco — San Francisco
- University of Miami - Sylvester Comprehensive Cancer Center — Miami
- The University of Chicago Comprehensive Cancer Center — Chicago
- University of Kentucky Markey Cancer Center — Lexington
- … and 13 more centers
Identifiers
NCT: NCT06778863 · CLSP-1025-101