Advanced Solid TumorPhase 1/2NCT05052268
XTX202 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing XTX202 in people with Advanced Solid Tumor, run by Xilio Development, Inc. at 15 sites in United States.
Trial summary
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- XTX202
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 15 sitesUnited States
- Study dates
- 18 Jan 2022to 25 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California Los Angeles
Los Angeles, California, 90095
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, 07960
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, 08903
Hoag Memorial Hospital Presbyterian- Newport Beach
Newport Beach, California, 92663
UPMC Hillman Cancer Center Pavilion
Pittsburgh, Pennsylvania, 15213
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
Moffitt Cancer Center
Tampa, Florida, 33612
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors
Read the 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 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202.
Based on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.
- Conditions
- Advanced Solid Tumor
- Being tested
- XTX202
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTX202Drug
XTX202 Monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion | Experimental | Part 1A Dose Escalation of XTX202 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 doses (RP2Ds).
Part 1B Evaluation of XTX202 in patients with selected advanced solid tumors to further characterize the pharmacodynamic profile of XTX202 Receives: Drug: XTX202 |
| Phase 2 XTX202 Dose Expansion | Experimental | 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. Receives: Drug: XTX202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following:
- Any treatment-related Grade ≥ 3 toxicity
- Any Grade febrile neutropenia
- The following nonhematologic exceptions:
- Grade 3 nausea or vomiting lasting < 3 days
- Grade 3 fatigue lasting < 7 days
- Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days
Measured: 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)
Incidence of Treatment-emergent Adverse Events (Phase 1 Only)
Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0.
Measured: Up to 24 months
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 2 Only)
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1.
In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Measured: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Measured: up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Measured: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value
Measured: Up to 24 months
Secondary outcomes (28)
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response will be based on Investigator's assessment according to RECIST v1.1.
Measured: Up to 24 months
Duration of Response (DOR) (Phase 2 Only)
Duration of response is defined as time from first documentation of a subsequently confirmed objective response (CR or PR) to the date of the first documentation of radiographic disease progression according to Investigator assessment by RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.
Measured: Up to 24 months
Disease Control Rate (Phase 2 Only)
Disease Control Rate (DCR) is defined as percentage of participants with confirmed BOR of CR, PR or SD (minimum duration of 6 weeks) according to RECIST v1.1, after the first dose of study treatment.
In the analysis set used for DCR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: Up to 24 months
Overall Survival (OS) (Phase 2 Only)
OS is defined as the time from first administration of study treatment to death due to any cause. For participants without a record of death, OS will be censored at the date they were last known alive.
In the analysis set used for OS, participants are assigned to a treatment group based on the initial dose received.. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Measured: Up to 24 months
Progression-free Survival (PFS) (Phase 2 Only)
PFS is defined as the time from first administration of study treatment until first documentation of radiographic PD according to RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.
In the analysis set used for PFS, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Measured: Up to 24 months
Incidence of Treatment-emergent Adverse Events (Phase 2 Only)
Treatment-emergent adverse event is defined as any adverse event (AE) that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. AEs are graded using the NCI CTCAE version 5.0.
Measured: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Measured: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Measured: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Measured: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Measured: Up to 24 months
Plasma Concentrations of Total XTX202
Plasma Concentration of Total XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Plasma Concentrations of Intact XTX202
Plasma Concentration of Intact XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Total XTX202 Plasma Trough Concentration
Plasma Trough Concentration of Total XTX202 Following Multiple IV Administrations of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Measured: From Cycle 1 to up to Cycle 18 (21 days per cycle)
Intact XTX202 Plasma Trough Concentration
Plasma Trough Concentration of Intact XTX202 Following Multiple IV Administrations of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: from Cycle 1 to up to Cycle 18 (21 days per cycle)
Maximum Observed Plasma Concentration (Cmax) of Total XTX202
Cmax following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Intact XTX202
Cmax following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Total XTX202
Time of maximum observed concentration (Tmax) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Intact XTX202
Time of maximum observed concentration (Tmax) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202
Area under the curve (AUC)of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202
Area under the curve (AUC) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Total XTX202
Half-life (T1/2) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Intact XTX202
Half-life (T1/2) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Total XTX202
Systemic clearance (CL) of Total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Intact XTX202
Systemic clearance (CL) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Total XTX202
Volume of distribution (Vd) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Intact XTX202
Volume of distribution (Vd) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only)
Overall ADA Incidence Following a Single IV Administration of XTX202
In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: from Cycle 1 Day 1 to up to 24 months
Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only)
Overall ADA Incidence Following a Single IV Administration of XTX202.
In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Measured: From Cycle 1 Day 1 to up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start18 Jan 2022
- Primary completion22 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xilio Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052268
- Sponsor's protocol ID
- XTX202-01/02-001
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2021
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05052268
- Acronym / sponsor ID
- XTX202-01/02-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Xilio Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors
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 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202.
Based on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion | Experimental | Drug: XTX202Part 1A Dose Escalation of XTX202 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 doses (RP2Ds). Part 1B Evaluation of XTX202 in patients with selected advanced solid tumors to further characterize the pharmacodynamic profile of XTX202 |
| Phase 2 XTX202 Dose Expansion | Experimental | Drug: XTX202Part 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Disease Criteria
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XTX202XTX202 Monotherapy | Drug | Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion, Phase 2 XTX202 Dose Expansion |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A 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)
All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following: * Any treatment-related Grade ≥ 3 toxicity * Any Grade febrile neutropenia * The following nonhematologic exceptions: * Grade 3 nausea or vomiting lasting < 3 days * Grade 3 fatigue lasting < 7 days * Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days
Incidence of Treatment-emergent Adverse Events (Phase 1 Only)
Time frame: Up to 24 months
Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0.
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 2 Only)
Time frame: Up to 24 months
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1. In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry
Time frame: Up to 24 months
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology
Time frame: up to 24 months
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function
Time frame: Up to 24 months
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation
Time frame: Up to 24 months
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value
28 secondary outcomes
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Time frame: Up to 24 months
Duration of Response (DOR) (Phase 2 Only)
Time frame: Up to 24 months
Disease Control Rate (Phase 2 Only)
Time frame: Up to 24 months
Overall Survival (OS) (Phase 2 Only)
Time frame: Up to 24 months
Progression-free Survival (PFS) (Phase 2 Only)
Time frame: Up to 24 months
Incidence of Treatment-emergent Adverse Events (Phase 2 Only)
Time frame: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology
Time frame: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry
Time frame: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function
Time frame: Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation
Time frame: Up to 24 months
Plasma Concentrations of Total XTX202
Time frame: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Plasma Concentrations of Intact XTX202
Time frame: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Total XTX202 Plasma Trough Concentration
Time frame: From Cycle 1 to up to Cycle 18 (21 days per cycle)
Intact XTX202 Plasma Trough Concentration
Time frame: from Cycle 1 to up to Cycle 18 (21 days per cycle)
Maximum Observed Plasma Concentration (Cmax) of Total XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Intact XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Total XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Intact XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Total XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Intact XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Total XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Intact XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Total XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Intact XTX202
Time frame: up to 21 days following a single IV infusion of XTX202 on Cycle 1
Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only)
Time frame: from Cycle 1 Day 1 to up to 24 months
Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only)
Time frame: From Cycle 1 Day 1 to up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XTX202 in people with Advanced Solid Tumor, run by Xilio Development, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.