What is the mechanism of action of this treatment?

Common treatments for solid tumors, particularly those similar to XTX202, include targeted therapies and immunotherapies. Targeted therapies work by inhibiting specific molecules and pathways critical for tumor growth and survival, such as tyrosine kinase inhibitors that block signaling pathways essential for cancer cell proliferation. Immunotherapies, like checkpoint inhibitors, enhance the body's immune response against tumor cells by blocking proteins that suppress immune activity. These mechanisms are important for solid tumor patients as they provide more precise and potentially more effective treatment options with fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for solid tumors that target pathways or markers associated with tumor growth and survival, such as targeted therapies and immunotherapies, often have a range of side effects. These can include hematologic toxicities like decreased neutrophil count and anemia, gastrointestinal issues such as nausea and diarrhea, and fatigue. Specific agents may also have unique side effects; for example, T-DXd is associated with interstitial lung disease, and pembrolizumab can cause immune-related adverse events like pneumonitis and colitis. It is important for patients to be closely monitored for these side effects during treatment.

What prior FDA approvals exist?

Several novel therapeutic agents have been approved by the FDA for the treatment of solid tumors, focusing on targeting specific pathways or markers associated with tumor growth and survival. For instance, pembrolizumab and nivolumab are immune checkpoint inhibitors that target the PD-1 pathway, enhancing the body's immune response against tumors. Atezolizumab, another immune checkpoint inhibitor, targets the PD-L1 pathway. Additionally, cabozantinib, a tyrosine kinase inhibitor, targets multiple pathways including VEGFR, MET, and AXL, which are involved in tumor growth and angiogenesis. These drugs exemplify the trend towards precision medicine in oncology, aiming to disrupt specific molecular mechanisms driving cancer progression.

What other types of research exist?

Promising novel alternatives to XTX202 for solid tumor patients include: <ol> <li>GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas, which targets specific tumor markers.</li> <li></li> </ol> ONC201, a selective DRD2 antagonist, showing efficacy in H3 K27M-mutant diffuse midline gliomas. 3. Pembrolizumab, an immune checkpoint inhibitor, used in various solid tumors including sarcomas and mesotheliomas. 4. Nivolumab plus ipilimumab, another combination of immune checkpoint inhibitors, showing promise in metastatic sarcomas and mesotheliomas. 5. Cabozantinib, a tyrosine kinase inhibitor, effective in medullary thyroid cancer and potentially other solid tumors.

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XTX202 for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by Xilio Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically or cytologically confirmed solid tumor malignancy with specific tumor histologies (RCC of clear cell histology, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer) who have derived benefit from previous immunotherapy

Patients with 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

Must not have

History of clinically significant pulmonary disease

History of clinically significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing XTX202, a new drug designed to treat advanced cancers. It targets patients with late-stage solid tumors that may not respond to other treatments. The drug remains inactive until it reaches the tumor, where it then activates to help the immune system fight the cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects of XTX202 are not detailed here since it's a first-in-human study, common side effects of similar drugs include fatigue, nausea, skin reactions at injection sites, fever-like symptoms such as chills or sweating; organ inflammation; increased risk of infections due to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I have kidney cancer that worsened after treatment with specific immune and targeted therapies.

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I have a BRAF V600 mutation and have been treated with targeted therapy.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious lung condition.

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I have a history of serious heart problems.

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I have been treated with IL-2 therapy before.

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I have been diagnosed with an immune system disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2 XTX202 Dose ExpansionExperimental Treatment1 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 ExpansionExperimental Treatment1 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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors, particularly those similar to XTX202, include targeted therapies and immunotherapies. Targeted therapies work by inhibiting specific molecules and pathways critical for tumor growth and survival, such as tyrosine kinase inhibitors that block signaling pathways essential for cancer cell proliferation. Immunotherapies, like checkpoint inhibitors, enhance the body's immune response against tumor cells by blocking proteins that suppress immune activity. These mechanisms are important for solid tumor patients as they provide more precise and potentially more effective treatment options with fewer side effects compared to traditional chemotherapy.