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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 36 months
Awards & highlights
Study Summary
This trial tests a new cancer drug to see if it is safe and effective in people with advanced forms of cancer.
Who is the study for?
Adults with advanced or metastatic solid tumors or non-Hodgkin lymphoma that have not responded to standard treatments can join. They must be in good general health, able to use effective birth control, and willing to provide tissue samples. People with certain heart issues, active autoimmune diseases, recent major surgery or radiotherapy, infections like HIV/HBV/HCV, other cancers within the last 2 years (with some exceptions), CNS malignancies, unresolved toxicities from past treatments (except minor ones), known allergies to study drug components, significant cardiovascular disease, prior IL-12 treatment including intratumoral injection or allogeneic therapies are excluded.Check my eligibility
What is being tested?
WTX-330 is being tested as a solo therapy for patients who have tried everything else without success. This first-in-human trial is open-label and multicenter. It involves two phases: dose escalation to find the safe amount of WTX-330 and dose expansion where more participants receive this determined dose.See study design
What are the potential side effects?
As WTX-330 is new and this trial is its first test in humans (Phase 1), specific side effects aren't listed yet but generally could include typical reactions such as immune system responses causing inflammation in various organs; infusion-related reactions; fatigue; digestive disturbances; blood disorders; increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 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)
Incidence of changes in clinical laboratory abnormalities
Incidence of treatment emergent adverse events
+1 moreSecondary outcome measures
Antidrug antibody (ADA) occurrence
Changes in circulating immune cell populations
Changes in soluble cytokines including IL-2, IL-4, IL-6, IL-10, IFN-γ and IP-10
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B)Experimental Treatment1 Intervention
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
Group II: WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A)Experimental Treatment1 Intervention
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
Group III: WTX-330 dose escalationExperimental Treatment1 Intervention
Patients with relapsed/refractory advanced or metastatic solid tumors
Find a Location
Who is running the clinical trial?
Werewolf Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an allogeneic stem cell transplant or CAR-T cell therapy.I do not have an active, uncontrolled infection.My cancer originated in my brain or spinal cord.I have previously been treated with IL-12.I have not received a live vaccine in the last 30 days.I have not had radiotherapy in the last 2 weeks.I am HIV-positive and have had Kaposi sarcoma or Multicentric Castleman Disease.I have an immune system disorder or I'm on medication that weakens my immune system.I am not taking medication that is sensitive to major liver enzymes.I agree to have biopsies before and during treatment.I have an active hepatitis B or C infection.I have a serious heart condition.I have not had any other cancer besides my current one in the last 2 years.My organs and bone marrow are working well.I am fully active or restricted in physically strenuous activity but can do light work.I don't have severe side effects from previous treatments.I have brain metastases that show symptoms or needed treatment in the last 2 weeks.I have not had major surgery in the last 2 weeks.I agree to use effective birth control during and for 4 months after treatment.I am HIV positive, on treatment, and my condition is well-managed.My cancer has returned or spread and doesn't respond to standard treatments.I am 18 years old or older.I haven't taken any experimental drugs or cancer treatments in the last 4 weeks.My advanced cancer has not responded to standard treatments or I cannot tolerate them.
Research Study Groups:
This trial has the following groups:- Group 1: WTX-330 dose escalation
- Group 2: WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A)
- Group 3: WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B)
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.
Are there still opportunities to join this clinical experiment?
"Data on clinicaltrials.gov reveals that this medical experiment is still searching for participants. It was initially published in December 6th 2022 and the most recent update to its information occurred during January 6th 2023."
Answered by AI
Has the WTX-330 dose escalation protocol been sanctioned by the FDA?
"Our experts at Power have determined that WTX-330 dose escalation is of low safety risk, scoring a 1 on their scale due to the limited information available regarding its efficacy and security."
Answered by AI
To what extent is this clinical experiment recruiting participants?
"Affirmative. The information accessible on clinicaltrials.gov indicates that this research is actively looking for participants, with an initial posting date of December 6th 2022 and a recent update from January 6th 2023. 75 individuals are needed to be enrolled from 1 study centre."
Answered by AI
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