XTX301 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A First-in-Human, Multicenter, Phase 1, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05684965
• Other study ID #: XTX301-01/02-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 11, 2023
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: Xilio Development, Inc.
• Contact: Teleen Norman
• Phone: 203-584-5310
• Email: tnorman[@]xiliotx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a first-in-human, multicenter, Phase 1, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.

Description:

This is a first-in-human, multicenter, Phase 1, open-label study designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and efficacy of XTX301, a tumor-activated interleukin-12, as monotherapy in patients with advanced solid tumors.

Part 1A will examine XTX301 monotherapy in a standard 3+3 dose escalation design. Based on the results of Part 1A, patients with select advanced solid tumors will be enrolled in Part 1B, which will evaluate XTX301 monotherapy in relation to specific PD biomarkers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available.

Part 1B- Any histologically or cytologically confirmed solid tumor malignancy among the tumor types outlined below, that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available. Patients with the following tumor types are eligible for Part 1B: melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, triple-negative breast cancer (TNBC), MSI-H/dMMR colorectal cancer,T-cell lymphoma, MSI-H/dMMR endometrial cancer, prostate cancer, ovarian cancer, pancreatic cancer, and microsatellite stable colorectal cancer.

• ECOG performance status of 0-2

• Adequate organ function

• Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment

• Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery before receiving study drug

Exclusion Criteria:

• Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)

• Known liver metastasis based on imaging

• Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture

• Active primary central nervous system (CNS) malignancy, CNS metastases, and/or carcinomatous meningitis

• Active autoimmune disease

• History of Grade = 3 immune-related adverse events associated with prior immunotherapy unless these were adequately resolved with therapy within 14 days

• A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of study drug

• Active hepatitis B or active hepatitis C infection

• Prior treatment with gene therapy, organ transplant, or hematopoietic stem-cell transplant

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• XTX301
XTX301 monotherapy

Locations

Country	Name	City	State
United States	The Gabrail Pharmacology Phase 1 Research Center	Canton	Ohio
United States	University Hospital Cleveland Medical Center	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Yale Cancer Center	New Haven	Connecticut
United States	University of Pittsburgh Medical Center-Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	University of California, Davis Comprehensive Cancer Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	HealthPartners Frauenshuh Cancer center	Saint Louis Park	Minnesota
United States	Tranquil Clinical Research	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Xilio Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose Limiting Toxicities (DLTs) (Part 1A only)		Cycle 1 Day 1 up to just prior to the second dose of the study drug at Cycle 2 Day 1 (approximately 21 days)
Primary	Incidence of treatment-emergent adverse events (TEAEs) and changes in clinical laboratory values (Part 1A & 1B)		Up to 24 months
Secondary	Plasma concentrations of XTX301		Up to 24 months
Secondary	Maximum observed plasma concentration (Cmax)		Up to 24 months
Secondary	Time of maximum observed concentration (Tmax)		Up to 24 months
Secondary	Trough concentration (Ctrough)		Up to 24 months
Secondary	Area under the curve (AUC)		Up to 24 months
Secondary	Half-life (T1/2)		Up to 24 months
Secondary	Systemic clearance (CL)		Up to 24 months
Secondary	Volume of distribution (Vd)		Up to 24 months
Secondary	Antidrug antibody (ADA) occurrence and titer in serum		Up to 24 months
Secondary	Investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1		Up to 24 months