WTX-330 for Advanced Cancers

No longer recruiting at 9 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Werewolf Therapeutics, Inc.

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS metastases, Cardiovascular disease, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment called WTX-330 for individuals with advanced or hard-to-treat cancers. It targets those with solid tumors or non-Hodgkin lymphoma that have not responded well to standard treatments. The trial tests different doses of WTX-330 to identify the most effective one. Individuals with advanced cancer unresponsive to typical treatments might be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how WTX-330 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you have taken certain investigational agents or anticancer therapies recently, or if you are using sensitive substrates of major CYP450 isozymes. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that WTX-330 is likely to be safe for humans?

Research has shown that WTX-330 is likely safe and well-tolerated. In early studies, patients with advanced solid tumors handled the treatment well. Signs of effectiveness appeared, which is encouraging for those considering joining the trial. These results came from patients who had tried many other treatments without success, suggesting that WTX-330 might be a good option for those with limited choices. However, since this is the first time WTX-330 is being tested in humans, more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about WTX-330 for advanced cancers because it offers a fresh approach compared to standard treatments like chemotherapy, radiation, or CPI therapies such as anti-PD(L)1 regimens. Unlike these traditional methods, WTX-330 is designed to target and modulate the immune system in a novel way, potentially overcoming primary or secondary resistance seen in some patients. This could provide a new lifeline for those whose cancers resist current immune checkpoint inhibitors, by potentially bolstering the immune response more effectively. The unique mechanism that WTX-330 employs might offer hope for better outcomes in patients with refractory or metastatic tumors.

What evidence suggests that WTX-330 could be an effective treatment for advanced cancers?

Research has shown that WTX-330 yields promising results for patients with advanced or spreading solid tumors. Early clinical findings suggest it is safe and may work well in patients who have undergone multiple treatments. In studies with mice, WTX-330 activated the immune system and demonstrated a strong ability to fight tumors. This trial includes different arms to evaluate WTX-330, such as dose escalation and dose expansion for patients with varying indications for CPI therapy. These early results support the potential of WTX-330 as a single treatment for different types of cancer. While more information is needed, these findings offer hope for its use against certain cancers. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced or metastatic solid tumors or non-Hodgkin lymphoma that have not responded to standard treatments can join. They must be in good general health, able to use effective birth control, and willing to provide tissue samples. People with certain heart issues, active autoimmune diseases, recent major surgery or radiotherapy, infections like HIV/HBV/HCV, other cancers within the last 2 years (with some exceptions), CNS malignancies, unresolved toxicities from past treatments (except minor ones), known allergies to study drug components, significant cardiovascular disease, prior IL-12 treatment including intratumoral injection or allogeneic therapies are excluded.

Inclusion Criteria

I agree to have biopsies before and during treatment.

At least one measurable lesion per RECIST 1.1 or an evaluable lesion per Lugano classification (for lymphoma)

My organs and bone marrow are working well.

Exclusion Criteria

I have had an allogeneic stem cell transplant or CAR-T cell therapy.

I do not have an active, uncontrolled infection.

My cancer originated in my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation conducted in patients with advanced and/or metastatic solid tumors who are refractory to all standard of care therapies

8-12 weeks

Dose Expansion

Dose expansion conducted in two arms: Arm A for patients with indications for which a checkpoint inhibitor is indicated/approved, and Arm B for patients with tumor types for which CPI therapy is not indicated/approved

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WTX-330

Trial Overview WTX-330 is being tested as a solo therapy for patients who have tried everything else without success. This first-in-human trial is open-label and multicenter. It involves two phases: dose escalation to find the safe amount of WTX-330 and dose expansion where more participants receive this determined dose.

How Is the Trial Designed?

Group I: WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B) Experimental Treatment 1 Intervention

WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved

Group II: WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A) Experimental Treatment 1 Intervention

WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen

Group III: WTX-330 dose escalation Experimental Treatment 1 Intervention

Patients with relapsed/refractory advanced or metastatic solid tumors

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. 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, ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-03403

A Phase 1b/2 Multisite Dose-finding and Expansion Study ... The goal of this clinical trial is to evaluate the safety and tolerability of the study drug WTX-330 when administered using a fixed dose regimen or a ...

4. 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 ... Preliminary clinical findings presented at SITC demonstrate WTX-330's promising therapeutic potential as a monotherapy, exhibiting a favorable ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10320472/

mWTX-330, an IL-12 INDUKINE Molecule, Activates and ... Systemic administration of mWTX-330 in mice was well tolerated, resulted in robust antitumor immunity in multiple tumor models, and preferentially activated ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06939283

A Phase 1b/2 Multisite Dose-finding and Expansion Study ... The goal of this clinical trial is to evaluate the safety and tolerability of the study drug WTX-330 when administered using a fixed dose regimen or a ...

8. longwoodfund.com longwoodfund.com/2024/06/26/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-non-hodgkin-ly/

Werewolf Therapeutics Highlights Initial Safety and Efficacy ... Werewolf Therapeutics Highlights Initial Safety and Efficacy Data from its Ongoing Phase 1 Clinical Trial Evaluating WTX-330 in Patients ...