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.

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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 36 months

Awards & highlights

Study Summary

This trial is testing a new drug, WTX-124, as a possible treatment for advanced solid tumors. WTX-124 will be given alone and in combination with another drug, pembrolizumab, to see if it is safe and effective.

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.Check my eligibility

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.See study design

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 ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

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) in monotherapy and combination therapy

Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy

Incidence of treatment emergent adverse events in monotherapy and combination therapy

Secondary outcome measures

Antidrug antibody (ADA) occurrence

Changes in circulating immune cell populations in response to monotherapy and combination therapy

Changes in soluble cytokines in response to monotherapy and combination therapy

+9 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

~5750

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.