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Monoclonal Antibodies
WTX-124 + Pembrolizumab for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Werewolf Therapeutics, Inc.
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 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new medicine called WTX-124, alone and with pembrolizumab, in patients with severe forms of skin and kidney cancer. WTX-124 helps the immune system attack cancer cells, and pembrolizumab makes it easier for the immune system to see these cells.
Who is the study for?
Adults over 18 with certain advanced solid tumors, able to undergo biopsies, and have at least one measurable tumor lesion. They must be relatively healthy (ECOG status of 0 or 1), not have had recent major surgery or other cancer treatments, no active infections like hepatitis B/C or HIV, and agree to effective birth control.
What is being tested?
The trial is testing WTX-124 alone and combined with Pembrolizumab in patients with advanced solid tumors. It's a Phase I study which means it's the first time humans are being tested for safety and dosage levels.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, flu-like symptoms, fatigue, skin reactions, potential infusion-related reactions from the drugs administered intravenously.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: WTX-124 monotherapy dose expansion in advanced or metastatic cutaneous malignant melanomaExperimental Treatment1 Intervention
Group II: WTX-124 monotherapy dose expansion in advanced or metastatic RCCExperimental Treatment1 Intervention
Group III: WTX-124 monotherapy dose escalationExperimental Treatment1 Intervention
Group IV: WTX-124 in combo with pembro dose expansion in advanced/metastatic cutaneous malignant melanomaExperimental Treatment2 Interventions
Group V: WTX-124 in combination with pembrolizumab dose expansion in advanced or metastatic RCCExperimental Treatment2 Interventions
Group VI: WTX-124 in combination with pembrolizumab dose escalationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5890
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 metastatic tumors often involve immunomodulation and direct anti-tumor activity. Immunomodulatory therapies, such as immune checkpoint inhibitors (e.g., anti-PD-1 or anti-CTLA-4 antibodies), enhance the body's immune response against tumor cells by blocking inhibitory pathways that prevent T-cells from attacking cancer cells.
Direct anti-tumor therapies, like targeted therapies and oncolytic viruses, aim to directly kill cancer cells or inhibit their growth. These mechanisms are crucial for metastatic tumor patients as they offer targeted approaches to control and potentially reduce tumor burden, improving survival and quality of life.
Tremelimumab: a review of development to date in solid tumors.New systemic treatment options for metastatic renal-cell carcinoma in the era of targeted therapies.
Tremelimumab: a review of development to date in solid tumors.New systemic treatment options for metastatic renal-cell carcinoma in the era of targeted therapies.
Find a Location
Who is running the clinical trial?
Werewolf Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,028 Previous Clinical Trials
5,189,385 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are functioning well.I need steroids for my brain cancer symptoms.I am fully active or can carry out light work.I do not have an ongoing serious infection.I have an immune system disorder or am on medication that weakens my immune system.I have previously received IL-2 therapy.I have not received a live vaccine within the last 30 days.I have received a transplant from another person.I have not had major surgery in the last 2 weeks.I had radiotherapy less than 2 weeks ago, except for short-term palliative care.My solid tumor is eligible for CPI treatment like anti-PD-(L)1.I agree to use effective birth control during and for 4 months after treatment.I agree to have biopsies before and during treatment.I do not have an active hepatitis C infection.I haven't had another active cancer in the past 2 years, except for certain low-risk types or localized cancers considered cured.I have been treated for an autoimmune disease in the last 2 years.I am 18 years old or older.I do not have an active hepatitis B infection.I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.I have at least one tumor that can be measured.I haven't taken any experimental cancer drugs or treatments within the last 4 weeks.I have a serious heart condition.I have or had lung inflammation that needed steroids.I am HIV-positive and have had Kaposi sarcoma or Multicentric Castleman Disease.
Research Study Groups:
This trial has the following groups:- Group 1: WTX-124 in combination with pembrolizumab dose expansion in advanced or metastatic RCC
- Group 2: WTX-124 monotherapy dose escalation
- Group 3: WTX-124 monotherapy dose expansion in advanced or metastatic cutaneous malignant melanoma
- Group 4: WTX-124 monotherapy dose expansion in advanced or metastatic RCC
- Group 5: WTX-124 in combo with pembro dose expansion in advanced/metastatic cutaneous malignant melanoma
- Group 6: WTX-124 in combination with pembrolizumab 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.
Metastatic Tumor Patient Testimony for trial: Trial Name: NCT05479812 — Phase 1