← Back to Search

Unknown

XTX202 for Solid Tumors

Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug for patients with advanced solid tumors. It is the first time this drug is being tested in humans.

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.Check my eligibility
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.See study design
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
Select...
I have a specific type of cancer and benefited from previous immunotherapy.
Select...
My cancer is advanced or has spread, and standard treatments have failed or aren't suitable.
Select...
I have melanoma that can't be removed by surgery and it got worse after treatment including an anti-PD-1.
Select...
I have kidney cancer that worsened after treatment with specific immune and targeted therapies.
Select...
I have a BRAF V600 mutation and have been treated with targeted therapy.
Select...
I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A only)
Incidence of changes in clinical laboratory values (Phase 1 only)
Incidence of treatment-emergent adverse events (Phase 1 only)
+1 more
Secondary outcome measures
Antidrug antibody (ADA) occurrence and titer in serum (Phase 1 only)
Area under the curve (AUC)
Disease control rate (Phase 2 only)
+13 more

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

Find a Location

Who is running the clinical trial?

Xilio Development, Inc.Lead Sponsor
2 Previous Clinical Trials
270 Total Patients Enrolled

Media Library

XTX202 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05052268 — Phase 1 & 2
Solid Tumors Research Study Groups: Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion, Phase 2 XTX202 Dose Expansion
Solid Tumors Clinical Trial 2023: XTX202 Highlights & Side Effects. Trial Name: NCT05052268 — Phase 1 & 2
XTX202 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05052268 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for individuals to join this clinical trial?

"According to the info on clinicaltrials.gov, this research effort is still recruiting participants. It was originally posted 18th of January 2022 and had its most recent update 2nd of November that same year."

Answered by AI

How many locations can participants access this clinical experiment?

"Currently, 8 medical centres are recruiting patients into this study. Huntersville, Boston and Newport Beach are some of the cities participating in the trial; additional sites can be found on the website. We suggest that you pick a centre close to your home to reduce any travel costs associated with enrolling in this study."

Answered by AI

How many total participants are enrolled in this clinical experiment?

"The sponsor, Xilio Development, Inc., will be running the trial out of multiple sites including Carolina BioOncology Institute in Huntersville and Massachusetts General Hospital. To execute this study successfully, a total 189 participants that meet its inclusion criteria are required."

Answered by AI
~7 spots leftby Apr 2024