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XTX301 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05684965
Recruitment Status : Not yet recruiting
First Posted : January 13, 2023
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Xilio Development, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : February 2027

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




Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLTs) (Part 1A only) [ Time Frame: Cycle 1 Day 1 up to just prior to the second dose of the study drug at Cycle 2 Day 1 (approximately 21 days) ]
  2. Incidence of treatment-emergent adverse events (TEAEs) and changes in clinical laboratory values (Part 1A & 1B) [ Time Frame: Up to 24 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05684965


Contacts
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Contact: Teleen Norman 203-584-5310 tnorman@xiliotx.com
Contact: Katarina Luptakova 617-372-2541 medicalaffairs@xiliotx.com

Sponsors and Collaborators
Xilio Development, Inc.
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Responsible Party: Xilio Development, Inc.
ClinicalTrials.gov Identifier: NCT05684965    
Other Study ID Numbers: XTX301-01/02-001
First Posted: January 13, 2023    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms