WTX-330 for Cancer

Recruiting at 4 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Werewolf Therapeutics, Inc.

Must be taking: Antiretroviral therapy

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Active malignancy, CNS malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, WTX-330, for individuals with certain advanced or metastatic cancers that no longer respond to standard treatments. Researchers aim to assess the safety and tolerability of WTX-330 when administered in various ways and doses. Participants will help determine the optimal dose and evaluate whether the drug can control cancer or extend patients' lives. The trial seeks adults with advanced melanoma, colorectal cancer, or non-Hodgkin lymphoma who have encountered issues with current treatments or cannot use standard options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have taken certain investigational agents or anticancer therapies within a specific time frame before starting the study drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that WTX-330 holds promise for safety in individuals with various advanced cancers. Early studies found that patients with late-stage solid tumors generally tolerated WTX-330 well. Many reported side effects were mild to moderate, such as tiredness and fever, suggesting a manageable safety profile.

In patients with microsatellite-stable colorectal cancer (CRC), the treatment was also mostly well-tolerated. Mild to moderate side effects were common, with no severe reactions reported, indicating a favorable safety profile for these patients.

For those with advanced non-Hodgkin lymphoma, similar results emerged. Most side effects, like tiredness and chills, were mild to moderate. These findings suggest that WTX-330 is generally safe and well-tolerated across different types of cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about WTX-330 because it offers a novel approach to treating certain cancers that have shown resistance to current therapies. Unlike standard treatments for conditions like cutaneous malignant melanoma, microsatellite-stable colorectal carcinoma, and advanced non-Hodgkin lymphoma—which typically involve standard-of-care checkpoint inhibitors or chemotherapies—WTX-330 works differently. It targets the immune system in a new way, potentially overcoming resistance seen with existing options. This unique mechanism could provide a new hope for patients who have not responded to other therapies, making it a promising development in cancer treatment.

What evidence suggests that this trial's treatment WTX-330 could be effective for cancer?

Research has shown that WTX-330 could be a promising treatment for advanced solid tumors such as melanoma, colorectal cancer, and non-Hodgkin lymphoma. In this trial, participants will join different treatment arms to evaluate its effectiveness. Early data suggest that WTX-330 is well-tolerated and shows initial signs of efficacy in patients who have undergone many previous treatments. WTX-330 reaches levels in the body that might help slow tumor growth. Notably, WTX-330, a modified form of a protein called IL-12, appears in the blood at levels 22 times higher than earlier IL-12 treatments. These findings suggest that WTX-330 could offer a new option for patients with these difficult-to-treat cancers. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced or metastatic solid tumors or lymphoma. Participants must be able to receive the study drug WTX-330 and follow the trial's procedures. Specific eligibility criteria are not provided, but typically include factors like type and stage of cancer, prior treatments, overall health status, and other medical conditions.

Inclusion Criteria

I agree to use effective birth control during and for 4 months after treatment.

I have HIV and am on ART with my condition under control.

My organs and bone marrow are working well.

Exclusion Criteria

I have been treated for an autoimmune disease in the last 2 years.

I have been treated with IL-12 before.

Any illness, medical condition, organ system dysfunction, or social situation likely to interfere with patient's ability to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose- and Regimen-finding

Participants receive WTX-330 using a fixed dose regimen for 28 days followed by a step-up dose regimen for 28 days to evaluate safety, tolerability, and determine the maximum tolerated dose

8 weeks

Dose Expansion

Participants are assigned to one of three arms to further evaluate the antitumor activity and pharmacokinetic profile of WTX-330

Varies by arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WTX-330

Trial Overview WTX-330 is being tested in two dosing regimens: a fixed dose and a step-up dose to find out which one is safer and more tolerable. The trial will also look at how well WTX-330 works against tumors, its effects on survival rates, how it interacts with the body (pharmacokinetics), immune response changes, and optimal dosing levels.

How Is the Trial Designed?

Group I: Dose- and Regimen Finding Experimental Treatment 1 Intervention

Regimen 1 Fixed Dose for 28 days then Regimen 2 Step-up Dose for 28 days

Group II: Dose Expansion Arm C Experimental Treatment 1 Intervention

n\~20 Patients with advanced NHL who are relapsed/refractory to SOC therapies and who are CPI naïve

Group III: Dose Expansion Arm B Experimental Treatment 1 Intervention

n\~20 Patients with locally advanced or metastatic microsatellite-stable (MSS) colorectal carcinoma (CRC) who have progressed on or are intolerant of SOC therapies and who are naïve to immunotherapy

Group IV: Dose Expansion Arm A Experimental Treatment 1 Intervention

n\~20 Patients with locally advanced or metastatic cutaneous malignant melanoma who have been treated with a standard of care (SOC) checkpoint inhibitor (CPI) regimen and who demonstrate primary or secondary resistance to this therapy

Who Is Running the Clinical Trial?

Werewolf Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

180+

Citations

1. investors.werewolftx.com investors.werewolftx.com/news-releases/news-release-details/werewolf-therapeutics-highlights-initial-safety-and-efficacy

Werewolf Therapeutics Highlights Initial Safety and Efficacy ... These preliminary clinical data show promising tolerability and signals of efficacy of WTX-330 in heavily pretreated patients with late-stage solid tumors.

2. werewolftx.gcs-web.com werewolftx.gcs-web.com/news-releases/news-release-details/werewolf-therapeutics-presents-preclinical-and-clinical-data

Werewolf Therapeutics Presents Preclinical and Clinical Data ... Pharmacokinetic improvements over rhIL-12: WTX-330 had 22-fold greater plasma exposure than the reported maximum tolerated dose of rhIL-12 but ...

3. clin.larvol.com clin.larvol.com/trial-detail/NCT05678998

WTX-330 in Patients With Advanced or Metastatic Solid ... A first-in-human, multi-center, open-label trial that will evaluate WTX-330 in patients with advanced or metastatic solid tumors or lymphoma resistant to ...

4. globenewswire.com globenewswire.com/news-release/2024/06/25/2903639/0/en/Werewolf-Therapeutics-Highlights-Initial-Safety-and-Efficacy-Data-from-its-Ongoing-Phase-1-Clinical-Trial-Evaluating-WTX-330-in-Patients-with-Advanced-or-Metastatic-Solid-Tumors-or.html

Werewolf Therapeutics Highlights Initial Safety and Data demonstrate that administration of WTX-330 reached therapeutically relevant exposure levels of systemically delivered IL-12 prodrug ...

5. stocktitan.net stocktitan.net/news/HOWL/werewolf-therapeutics-presents-preclinical-and-clinical-data-at-the-6xaq3jl6a3gf.html

Werewolf's WTX-330 Shows Promise in Phase 1 Trial The trial enrolled 25 patients with diverse solid tumors, showing favorable tolerability and encouraging efficacy. Key findings include a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05678998

WTX-330 in Patients With Advanced or Metastatic Solid ... This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety, tolerability and preliminary efficacy of WTX-330, ...

7. finance.yahoo.com finance.yahoo.com/news/werewolf-therapeutics-highlights-initial-safety-110000923.html

Werewolf Therapeutics Highlights Initial Safety and Efficacy ... Emerging tolerability profile: All patients exhibited mild to moderate treatment-related toxicities (fever, chills, cytopenias) primarily ...