XTX202 for Solid Tumors

Recruiting at 15 trial locations

Overseen By Katarina Luptakova, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Xilio Development, Inc.

Must not be taking: Il-2 therapy, Corticosteroids

Disqualifiers: Pulmonary, Cardiovascular, Immunodeficiency, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

95 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates XTX202, a new treatment for people with advanced solid tumors. It aims to determine the right dose and understand how the treatment works in the body. In Phase 1, the trial focuses on various advanced cancers, such as non-small cell lung cancer and melanoma. Phase 2 targets individuals with metastatic kidney cancer or melanoma who have not improved after standard treatments. This trial may suit those with these conditions who have not found success with standard treatments. As a Phase 1 and Phase 2 trial, it offers participants the opportunity to be among the first to receive a new treatment and evaluate its effectiveness in a smaller group.

Is there any evidence suggesting that XTX202 is likely to be safe for humans?

Research has shown that XTX202, a treatment for solid tumors, appears safe for humans. In earlier studies, patients with advanced solid tumors mostly experienced mild to moderate side effects, often referred to as treatment-related adverse events (TRAEs). For XTX202, these were mainly mild, which is reassuring.

Before human testing, XTX202 was tried on animals and showed positive results by targeting tumors without harming non-human primates, indicating potential human safety. The current clinical trial is in its early stages, focusing on safety, with careful monitoring to ensure patient safety. Overall, XTX202 has demonstrated a tolerable safety profile so far, with manageable side effects in studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about XTX202 because it offers a novel approach to treating advanced solid tumors, including metastatic renal cell carcinoma and melanoma. Unlike traditional treatments that often involve chemotherapy or targeted therapies, XTX202 is designed to potentially enhance the body's immune response against cancer cells. This treatment is particularly intriguing because of its unique mechanism targeting specific pathways that might lead to more effective and tailored cancer control. By focusing on pharmacodynamics and dose escalation, XTX202 aims to optimize its efficacy and safety profile, bringing hope for improved outcomes in patients who have exhausted standard-of-care options.

What evidence suggests that XTX202 might be an effective treatment for solid tumors?

Research has shown that XTX202, a new treatment for advanced solid tumors, appears promising in early studies. This trial includes a Phase 1 dose escalation and pharmacodynamics expansion arm, where researchers administer XTX202 in ascending doses to patients with advanced or metastatic solid tumors to determine the recommended Phase 2 doses. In a study with 62 patients, some maintained stable disease for over 18 months, particularly those with colorectal cancer that had spread to the liver. For kidney cancer, 70% of patients kept their disease under control for at least nine weeks. Among patients with melanoma, 56% experienced similar disease control. XTX202 is designed to specifically target tumors, potentially reducing side effects compared to other treatments. These early results suggest XTX202 could effectively manage certain advanced cancers. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have failed standard treatments or where no curative treatment exists. It's open to those in good physical condition (ECOG 0-1) and includes specific cancer types like RCC, melanoma, and lung cancer if they've benefited from immunotherapy before. Patients must not have significant heart disease, immune deficiencies, active infections needing systemic therapy recently, autoimmune diseases treated within the last two years, prior IL-2 therapy or serious lung disease.

Inclusion Criteria

I have a specific type of cancer and benefited from previous immunotherapy.

My cancer is advanced or has spread, and standard treatments have failed or aren't suitable.

I have melanoma that can't be removed by surgery and it got worse after treatment including an anti-PD-1.

Exclusion Criteria

I have not had an infection needing treatment in the last 4 weeks.

I have a serious lung condition.

I have an autoimmune disease treated with strong medication in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Phase 1 Part 1a involves dose escalation of XTX202 to determine the recommended phase 2 doses, followed by Part 1b to further characterize XTX202 in select tumors

12-16 weeks

Phase 2 Treatment

Phase 2 involves dose expansion of XTX202 in patients with metastatic renal cell carcinoma and melanoma

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• XTX202

Trial Overview XTX202 is being tested as a new potential treatment for various advanced solid tumors. The study has multiple phases: early ones assess safety and dosage in different cancers; later phases focus on effectiveness in kidney cancer (RCC) after anti-PD-1/TKI therapies and melanoma post checkpoint inhibitor therapy. Some patients may receive XTX202 before surgery to reduce tumor size.

How Is the Trial Designed?

Group I: Phase 2 XTX202 Dose Expansion Experimental Treatment 1 Intervention

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.

Group II: Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Xilio Development, Inc.

Lead Sponsor

Trials

3

Recruited

680+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2595

Phase 1/2 study of XTX202, a tumor-activated IL-2βγ, in ... Long-term disease control was observed with stable disease ongoing for >18 months in a pt with MSS colorectal cancer with liver metastases. In ...

2. ir.xiliotx.com ir.xiliotx.com/news-releases/news-release-details/xilio-announces-initial-monotherapy-safety-and-anti-tumor

Xilio Announces Initial Monotherapy Safety and Anti-Tumor ... As of a data cutoff date of October 26, 2023, 62 patients with advanced solid tumors had been administered XTX202 in an outpatient setting.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05052268

XTX202 in Patients With Advanced Solid Tumors 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 ...

4. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A695

611 XTX202–01/02–001, Phase 1/2 first-in human study of ... XTX202, a protein-engineered IL-2, exhibits tumor-selective activity in mice without peripheral toxicities in non-human primates.

5. clin.larvol.com clin.larvol.com/trial-detail/NCT05052268

XTX202 in Patients With Advanced Solid Tumors Investigators reported SD of at least nine-weeks duration in 7 RCC patients (70% disease control rate) and in 9 melanoma patients (56% disease control rate). In ...

6. xiliotx.com xiliotx.com/wp-content/uploads/2024/06/2024_ASCO_Clinical_XTX202_Poster.pdf

Phase 1/2 Study of XTX202, a Tumor-Activated IL- ... ... solid tumors (NCT05052268). Preliminary data demonstrated a tolerable safety profile in patients with advanced solid tumors, dose-proportional PK, tumor ...

7. xiliotx.com xiliotx.com/wp-content/uploads/2023/11/2023_SITC_Clinical_XTX202_Phase1-2.pdf

Conclusions for XTX202, a Tumor-Activated Engineered IL- ... XTX202 Safety: TRAEs Primarily Grade 1-2. 50% DCR at Doses ≥2.8 mg/kg ... XTX202 in advanced solid tumors is ongoing. (NCT05052268). Target Dose Range.