A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Purpose
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.
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A: Monotherapy Dose Escalation of CLSP-1025 |
Dose escalation of CLSP-1025 in HLA-A*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation |
|
|
Experimental Part B: Monotherapy Dose Expansion of CLSP-1025 |
Dose expansion of CLSP-1025 in HLA-A*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
Contact:
615-936-8422
615-936-8422
More Details
- Status
- Recruiting
- Sponsor
- Clasp Therapeutics, Inc.
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).