XTX202 in Patients With Advanced Solid Tumors

Sponsor
Xilio Development, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05052268
Collaborator
(none)
120
5
2
27.4
24
0.9

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jan 18, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 only) [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) [Up to 24 months]

  3. Incidence of changes in clinical laboratory values (Phase 1 only) [Up to 24 months]

  4. Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 2 only) [Up to 24 months]

Secondary Outcome Measures

  1. Plasma concentrations of XTX202 (total and intact) [Up to Cycle 7 (21 days per cycle)]

  2. Maximum observed plasma concentration (Cmax) [Up to Cycle 7 (21 days per cycle)]

  3. Time of maximum observed concentration (Tmax) [Up to Cycle 7 (21 days per cycle)]

  4. Trough concentrations (Ctrough) [Up to Cycle 7 (21 days per cycle)]

  5. Area under the curve (AUC) [Up to Cycle 7 (21 days per cycle)]

  6. Half-life (T1/2) [Up to Cycle 7 (21 days per cycle)]

  7. Systemic clearance (CL) [Up to Cycle 7 (21 days per cycle)]

  8. Volume of distribution (Vd) [Up to Cycle 7 (21 days per cycle)]

  9. Antidrug antibody (ADA) occurrence and titer in serum (Phase 1 only) [Up to 24 months]

  10. Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 1 only) [Up to 24 months]

  11. Duration of response (DOR) (Phase 2 only) [Up to 24 months]

  12. Disease control rate (Phase 2 only) [Up to 24 months]

  13. Progression-free survival (PFS) (Phase 2 only) [Up to 24 months]

  14. Overall survival (OS) (Phase 2 only) [Up to 24 months]

  15. Incidence of treatment-emergent adverse events (Phase 2 only) [Up to 24 months]

  16. Incidence of changes in clinical laboratory values (Phase 2 only) [Up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 HealthPartners Cancer Center at Regions Hospital Saint Paul Minnesota United States 55101
3 Carolina BioOncology Institute Huntersville North Carolina United States 28078
4 The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute Columbus Ohio United States 43210
5 Sarah Cannon Research Institute Nashville Tennessee United States 37203

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:
NCT05052268
Other Study ID Numbers:
  • XTX202-01/02-001
First Posted:
Sep 22, 2021
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022