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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 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

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.

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

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05479812 — Phase 1
Metastatic Tumor Research Study Groups: WTX-124 in combination with pembrolizumab dose expansion in advanced or metastatic RCC, WTX-124 monotherapy dose escalation, WTX-124 monotherapy dose expansion in advanced or metastatic cutaneous malignant melanoma, WTX-124 monotherapy dose expansion in advanced or metastatic RCC, WTX-124 in combo with pembro dose expansion in advanced/metastatic cutaneous malignant melanoma, WTX-124 in combination with pembrolizumab dose escalation
Metastatic Tumor Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05479812 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05479812 — Phase 1
Metastatic Tumor Patient Testimony for trial: Trial Name: NCT05479812 — Phase 1
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