Brief Title: CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s])

Primary Outcome 1 - Timeframe: 28 days after infusion

Primary Outcome 2 - Measure: 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

Primary Outcome 2 - Timeframe: Up to 24 months after infusion

CONDITION

• 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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Lauren Harshman, MD

Phone: +1-617-812-1431

Email: [email protected]

LOCATION