WTX-330 for Cancer

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

Trial Summary

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.

What is the purpose of this trial?

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 step-up dose regimen in adult patients with selected advanced or metastatic solid tumors or lymphoma. In addition to safety and tolerability, the study aims to: * determine the maximum initial dose of WTX-330 that may be used in the step-up dose regimen * determine whether the step-up dose regimen can increase WTX-330 exposure in patients due to improved tolerability * determine the maximum tolerated dose (MTD) of WTX-330 and/or recommended dose for expansion (RDE) for each regimen * evaluate the antitumor activity of WTX-330 * characterize the pharmacokinetic (PK) profile of WTX-330 * characterize the interferon gamma (IFNγ) profile after treatment with WTX-330 * evaluate changes in immunological biomarkers * determine the impact of WTX-330 on overall survival (OS) Study participants will participate in a dose- and regimen-finding phase (Part 1) followed by a dose expansion phase (Part 2) where they will be assigned to one of three arms (A, B and C).

Eligibility Criteria

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

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

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.

I have not had radiotherapy in the last 2 weeks.

Timeline

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

Treatment Details

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.

Participant Groups

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+