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
HonorHealth Research Institute
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Contact:
833-354-6667
833-354-6667
USC - Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
NYU Langone Health
New York, New York 10016
New York, New York 10016
Contact:
212-263-4432
212-263-4432
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
646-608-4042
646-608-4042
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
615-329-7640
615-329-7640
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Contact:
888-989-5374
888-989-5374
More Details
- NCT ID
- NCT06778863
- 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).