WTX-330 for Advanced Cancers

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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.

Eligibility Criteria

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.

Active autoimmune disease requiring systemic treatment in the past 2 years

Timeline

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

Treatment Details

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.

Participant Groups

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+