What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for metastatic tumors, particularly immunotherapies like PD-1 and PD-L1 inhibitors, often result in immune-related adverse events. These can affect various organs, including the skin, gastrointestinal tract, and endocrine organs. Serious adverse events (grades 3-4) occur in approximately 15% of patients and may include pneumonitis, colitis, hepatitis, and endocrinopathies. Other frequent side effects are fatigue, rash, diarrhea, and pruritus. These side effects reflect the overall class effect of immunotherapies and highlight the need for careful monitoring during treatment.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory drugs for the treatment of metastatic tumors. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors that target PD-1 and have been approved for various metastatic cancers, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma. Ipilimumab (Yervoy), which targets CTLA-4, is another approved immunotherapy for metastatic melanoma. These drugs work by enhancing the body's immune response against tumor cells. Additionally, atezolizumab (Tecentriq), targeting PD-L1, has been approved for metastatic NSCLC and urothelial carcinoma. These treatments are similar to WTX-124 in their immunomodulatory approach to combating cancer.

What other types of research exist?

Promising alternatives to WTX-124 for metastatic tumor patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, often used in combination with other therapies like bevacizumab or cabozantinib. 2) Nivolumab, another immune checkpoint inhibitor, which can be combined with ipilimumab or axitinib. 3) Anti-IL-23 monoclonal antibodies, which have shown potential in combination with IL-2 or trastuzumab. These therapies have demonstrated efficacy in various advanced cancers and are likely to be considered in treatment plans for 2024.

← Back to Search

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

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

Do I qualify?Apply below to find out

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.