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XTX202 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05052268
Recruitment Status : Not yet recruiting
First Posted : September 22, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Xilio Development, Inc.

Brief Summary:
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: XTX202 Phase 1 Phase 2

Detailed Description:

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of XTX202, an engineered IL-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors.

Phase 1 will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Phase 1, patients with select advanced solid tumors will be enrolled in Phase 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors
Estimated Study Start Date : November 30, 2021
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Arm Intervention/treatment
Experimental: Phase 1 XTX202 Dose Escalation
Phase 1 Dose Escalation of XTX202 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 dose (RP2D).
Drug: XTX202
XTX202 Monotherapy

Experimental: Phase 2 XTX202 Dose Expansion

Part 2A will enroll patients with metastatic renal cell carcinoma who have progressed following standard-of-care treatment.

Part 2B will enroll patients with melanoma who have progressed following standard-of-care treatment.

Drug: XTX202
XTX202 Monotherapy




Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 only) [ Time Frame: Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days) ]
  2. Incidence of treatment-emergent adverse events (Phase 1 only) [ Time Frame: Up to 24 months ]
  3. Incidence of changes in clinical laboratory values (Phase 1 only) [ Time Frame: Up to 24 months ]
  4. Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 2 only) [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Plasma concentrations of XTX202 (total and intact) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  2. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  3. Time of maximum observed concentration (Tmax) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  4. Trough concentrations (Ctrough) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  5. Area under the curve (AUC) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  6. Half-life (T1/2) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  7. Systemic clearance (CL) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  8. Volume of distribution (Vd) [ Time Frame: Up to Cycle 7 (21 days per cycle) ]
  9. Antidrug antibody (ADA) occurrence and titer in serum (Phase 1 only) [ Time Frame: Up to 24 months ]
  10. Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 1 only) [ Time Frame: Up to 24 months ]
  11. Duration of response (DOR) (Phase 2 only) [ Time Frame: Up to 24 months ]
  12. Disease control rate (Phase 2 only) [ Time Frame: Up to 24 months ]
  13. Progression-free survival (PFS) (Phase 2 only) [ Time Frame: Up to 24 months ]
  14. Overall survival (OS) (Phase 2 only) [ Time Frame: Up to 24 months ]
  15. Incidence of treatment-emergent adverse events (Phase 2 only) [ Time Frame: Up to 24 months ]
  16. Incidence of changes in clinical laboratory values (Phase 2 only) [ 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 - Phase 1: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an approved anti-PD-1 and a TKI. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with an approved anti-PD-1 and an anti-CTLA4 checkpoint inhibitor
  • ECOG performance status of 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Received prior treatment with IL-2 therapy
  • History of clinically significant pulmonary disease
  • History of clinically significant cardiovascular disease
  • Has a diagnosis of immunodeficiency
  • Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
  • Has an active infection requiring systemic therapy within 4 weeks prior to study treatment

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): NCT05052268


Contacts
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Contact: Teleen Norman +203-584-5310 tnorman@xiliotx.com
Contact: Martin Huber, MD +1-857-524-2456 mhuber@xiliotx.com

Sponsors and Collaborators
Xilio Development, Inc.
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Responsible Party: Xilio Development, Inc.
ClinicalTrials.gov Identifier: NCT05052268    
Other Study ID Numbers: XTX202-01/02-001
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
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