XTX301 in Patients With Advanced Solid Tumors

Sponsor

Xilio Development, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05684965

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: XTX301	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2027

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1A - XTX301 Monotherapy Dose Escalation Part 1A Dose Escalation of XTX301 administered in ascending doses to patients with advanced solid tumors to assess the safety and tolerability and determine the recommended Phase 2 dose (RP2D).	Drug: XTX301 XTX301 monotherapy
Experimental: Part 1B - XTX301 Monotherapy in Select Tumor Types Part 1B XTX301 will contribute to the assessment of safety and feasibility of XTX301 and will additionally allow pharmacodynamic assessment of XTX301.	Drug: XTX301 XTX301 monotherapy

Arm

Intervention/Treatment

Experimental: Part 1A - XTX301 Monotherapy Dose Escalation

Part 1A Dose Escalation of XTX301 administered in ascending doses to patients with advanced solid tumors to assess the safety and tolerability and determine the recommended Phase 2 dose (RP2D).

Drug: XTX301

XTX301 monotherapy

Experimental: Part 1B - XTX301 Monotherapy in Select Tumor Types

Part 1B XTX301 will contribute to the assessment of safety and feasibility of XTX301 and will additionally allow pharmacodynamic assessment of XTX301.

Drug: XTX301

XTX301 monotherapy

Outcome Measures

Primary Outcome Measures

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)]
Incidence of treatment-emergent adverse events (TEAEs) and changes in clinical laboratory values (Part 1A & 1B) [Up to 24 months]

Secondary Outcome Measures

Plasma concentrations of XTX301 [Up to 24 months]
Maximum observed plasma concentration (Cmax) [Up to 24 months]
Time of maximum observed concentration (Tmax) [Up to 24 months]
Trough concentration (Ctrough) [Up to 24 months]
Area under the curve (AUC) [Up to 24 months]
Half-life (T1/2) [Up to 24 months]
Systemic clearance (CL) [Up to 24 months]
Volume of distribution (Vd) [Up to 24 months]
Antidrug antibody (ADA) occurrence and titer in serum [Up to 24 months]
Investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, 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 1A: archival tumor tissue available or provide a fresh tumor biopsy. 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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tranquil Clinical Research	Webster	Texas	United States	77598

Sponsors and Collaborators

Xilio Development, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xilio Development, Inc.

ClinicalTrials.gov Identifier:

NCT05684965

Other Study ID Numbers:

XTX301-01/02-001

First Posted:

Jan 13, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jan 31, 2023