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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial tests a new cancer drug to check if it's safe and how people tolerate it.
Who is the study for?
This trial is for adults with advanced solid tumors like melanoma, lung, breast, and prostate cancer that have not responded to standard treatments. Participants must be in a stable condition (ECOG 0-2), have good organ function, and be able to provide tumor tissue samples. People with liver metastasis, active brain cancers or infections like hepatitis B/C, recent transplants or severe immune-related reactions from past immunotherapies cannot join.Check my eligibility
What is being tested?
XTX301 is being tested as a solo treatment for various advanced solid tumors. This first-in-human study aims to see how safe it is and what effects it has on patients who've run out of standard treatment options. It involves taking biopsies before and after starting the drug to closely monitor its impact.See study design
What are the potential side effects?
Since XTX301 is new and this trial marks its initial use in humans, specific side effects are unknown but may include typical reactions related to cancer therapies such as fatigue, nausea, inflammation responses or potential immune system complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
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) (Part 1A only)
Incidence of treatment-emergent adverse events (TEAEs) and changes in clinical laboratory values (Part 1A & 1B)
Secondary outcome measures
Antidrug antibody (ADA) occurrence and titer in serum
Area under the curve (AUC)
Half-life (T1/2)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 1B - XTX301 Monotherapy in Select Tumor TypesExperimental Treatment1 Intervention
Part 1B XTX301 will contribute to the assessment of safety and feasibility of XTX301 and will additionally allow pharmacodynamic assessment of XTX301.
Group II: Part 1A - XTX301 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Part 1A Dose Escalation of XTX301 administered in ascending doses to patients with advanced solid tumors to assess the safety and tolerability and determine the recommended Phase 2 dose (RP2D).
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Who is running the clinical trial?
Xilio Development, Inc.Lead Sponsor
2 Previous Clinical Trials
285 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active hepatitis B or C infection.I have previously been treated with IL-12 therapy.I do not have an active brain tumor or cancer spread to my brain or its coverings.I have an immune system disorder or take more than 10 mg of prednisone daily.I have not had gene therapy, organ, or stem-cell transplants.My cancer has spread to my liver.I can take care of myself and perform daily activities.My organs are working well.My cancer is advanced or has spread, and standard treatments haven't worked or aren't suitable.I can provide a sample of my tumor, either from previous tests or a new biopsy.I have fully recovered from any major surgery with no ongoing complications.I had a severe reaction to previous immunotherapy but it resolved in 2 weeks.My cancer type is one of the specified: melanoma, NSCLC, head and neck, TNBC, MSI-H/dMMR colorectal or endometrial, prostate, ovarian, pancreatic, or microsatellite stable colorectal.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1B - XTX301 Monotherapy in Select Tumor Types
- Group 2: Part 1A - XTX301 Monotherapy Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How likely is it that the Part 1A - XTX301 Monotherapy Dose Escalation will bring about a safe outcome for patients?
"Given the lack of clinical data in relation to safety and efficacy, Part 1A - XTX301 Monotherapy Dose Escalation was assigned a score of 1."
Answered by AI
Is it still possible to participate in this investigative endeavor?
"Affirmative, clinicaltrials.gov displays that this medical trial is still seeking participants. It was first uploaded on January 1st 2023 and recently amended on the 30th of the same month. The study requires 94 individuals from one particular site to take part in it."
Answered by AI
How many participants are currently engaging in this trial?
"Affirmative. Data provided on clinicaltrials.gov confirms enrollment for this trial, which was first made available to the public in January 1st of 2023 and has since been updated multiple times. The research team is recruiting 94 individuals from a single site."
Answered by AI
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