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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
Has at least 1 measurable lesion per RECIST 1.1 (lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My solid tumor is eligible for CPI treatment like anti-PD-(L)1.

Timeline

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
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
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
2018
Completed Phase 3
~6240

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
3,862 Previous Clinical Trials
5,049,550 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 combo with pembro dose expansion in advanced/metastatic cutaneous malignant melanoma, WTX-124 monotherapy 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 in combination with pembrolizumab dose escalation, WTX-124 in combination with pembrolizumab dose expansion in advanced or metastatic RCC
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned WTX-124 for use?

"Our team at Power gave WTX-124 a score of 1 on the safety scale, as this is still an early stage trial with limited evidence regarding efficacy and safety."

Answered by AI

Are there any vacancies open for prospective participants in this clinical trial?

"Affirmative. The data hosted on clinicaltrials.gov suggests that this trial is presently searching for participants and was initially posted on May 20th 2022, with a recent edit taking place October 27th of the same year. 150 patients are needed to be recruited from 6 separate sites."

Answered by AI

How many sites are participating in the execution of this clinical trial?

"This clinical trial is conveniently located at Honorhealth in Atlanta, Georgia, Emory Winship Cancer Institute in Indianapolis, Indiana and the Melvin and Bren Simon Comprehensive Cancer Center of Indiana University in San Antonio Texas. Additionally, it can be found at 6 other sites throughout the country."

Answered by AI

How many people have opted in to participate in this medical experiment?

"150 suitable volunteers are necessary for successful completion of the trial. These participants can be recruited from Honourhealth in Atlanta, Georgia and Emory Winship Cancer Institute located in Indianapolis, Indiana."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have colon cancer i was diagnosed on 30 october 2021 and i have started chemotherapy folfox protocol on 21 november 2021 for 6 months duration and the disease progressed again after two months of stopping the chemotherapy and i statred keytruda on 28 august 2022 for up to 1 year now and my case is now still stationary.
PatientReceived 2+ prior treatments
~61 spots leftby Jul 2025