Phase 2
N=95
XTX202 in Patients With Advanced Solid Tumors
Advanced Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT05052268 ↗Enrolled (actual)
95
Serious AEs
14.7%
Results posted
May 2026
Primary outcome: Primary: Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only) — 0; 0; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- XTX202 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xilio Development, Inc.
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only) |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Incidence of Treatment-emergent Adverse Events (Phase 1 Only) |
1; 2; 3; 8; 13; 8 | — |
| PRIMARY Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 2 Only) |
0; 0; 16.7; 0 | — |
| PRIMARY Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry |
1; 0; 0; 1; 0; 0 | — |
| PRIMARY Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology |
0; 0; 0; 1; 3; 1 | — |
| PRIMARY Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Response (DOR) (Phase 2 Only) |
NA | — |
| SECONDARY Disease Control Rate (Phase 2 Only) |
100; 50; 50; 53.8 | — |
| SECONDARY Overall Survival (OS) (Phase 2 Only) |
NA; NA; NA; NA | — |
| SECONDARY Progression-free Survival (PFS) (Phase 2 Only) |
4.1; 4.1; 3.1; 2.7 | — |
| SECONDARY Incidence of Treatment-emergent Adverse Events (Phase 2 Only) |
2; 15; 5; 15 | — |
| SECONDARY Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology |
0; 1; 1; 1; 0; 0 | — |
| SECONDARY Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Plasma Concentrations of Total XTX202 |
NA; NA; 0; 0; 0; 0 | — |
| SECONDARY Plasma Concentrations of Intact XTX202 |
NA; 0; 0; 0; 0; 0 | — |
| SECONDARY Total XTX202 Plasma Trough Concentration |
NA; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Intact XTX202 Plasma Trough Concentration |
NA; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Total XTX202 |
4410; 7130; 8400; 18500; 27700; 45700 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Intact XTX202 |
4300; 6810; 9550; 18300; 27300; 45800 | — |
| SECONDARY Time of Maximum Observed Concentration (Tmax) of Total XTX202 |
2.05; 1.00; 168; 0.710; 0.658; 0.981 | — |
| SECONDARY Time of Maximum Observed Concentration (Tmax) of Intact XTX202 |
2.05; 1.00; 126; 0.694; 0.680; 1.05 | — |
| SECONDARY Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202 |
479000; 653000; 1050000; 1490000; 2310000; 3770000 | — |
| SECONDARY Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202 |
469000; 639000; 1010000; 1440000; 2160000; 3630000 | — |
| SECONDARY Half-life (T1/2) of Total XTX202 |
NA; 200; 207; 238; 187; 207 | — |
| SECONDARY Half-life (T1/2) of Intact XTX202 |
NA; 210; 208; 229; 192; 205 | — |
| SECONDARY Systemic Clearance (CL) of Total XTX202 |
NA; 0.0461; 0.0487; 0.0418; 0.0406; 0.0537 | — |
| SECONDARY Systemic Clearance (CL) of Intact XTX202 |
NA; 0.0475; 0.0489; 0.0418; 0.0426; 0.0556 | — |
| SECONDARY Volume of Distribution (Vd) of Total XTX202 |
NA; 13.2; 14.6; 13.5; 10.8; 13.7 | — |
| SECONDARY Volume of Distribution (Vd) of Intact XTX202 |
NA; 14.1; 14.8; 13.2; 11.7; 14.0 | — |
| SECONDARY Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only) |
0; 1; 3; 4; 5; 3 | — |
| SECONDARY Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only) |
0; 0; 1; 0 | — |
Summary
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria
- Disease Criteria
- Phase 1, Part 1a: 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 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort".
- Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. 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 at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care.
- ECOG performance status of 0 or 1
- Adequate organ function
- Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.
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
Data sourced from ClinicalTrials.gov (NCT05052268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.