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Advanced or Metastatic Solid TumorsPhase 1/2NCT06939283

A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Lymphoma

A Phase 1/2 study testing WTX-330 in people with Advanced or Metastatic Solid Tumors and Non-Hodgkin Lymphoma, run by Werewolf Therapeutics, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
WTX-330
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
5 sitesUnited States
Study dates
21 Apr 2025to 23 Apr 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years,
  • Dose escalation (Part 1): Patients with relapsed/refractory locally advanced or metastatic solid tumor for which the patient has progressed on or is intolerant of standard therapy, or for whom no standard therapy with proven benefit exists. Patients with castrate resistant prostate cancer (CRPC) and primary Central Nervous System (CNS) malignancies are ineligible. Patients with non-Hodgkin lymphoma (NHL) will not be enrolled in the dose escalation but are eligible for the dose expansion.
  • Dose Expansion (Part 2): Patients with relapsed/refractory locally advanced or metastatic cutaneous melanoma, MSS CRC or NHL for which the patient has progressed on or is intolerant of standard therapy. The dose expansion consists of 3 arms (A, B and C) with the following eligibility criteria:
  • Arm A: Patients with locally advanced or metastatic cutaneous melanoma who demonstrate either primary or secondary resistance to checkpoint inhibitor (CPI) therapy. Patients must have received at least 1 prior line that was a SOC CPI regimen and are allowed no more than 3 prior lines for advanced disease. Prior T-VEC therapy is allowed and does not count as a prior line, but treated lesions cannot be used as target lesions or accessed for mandatory pre- and on-treatment biopsies.
  • Arm B: Patients with relapsed/refractory locally advanced or metastatic MSS CRC who are immunotherapy naïve. Patients should have had no more than 3 prior lines of therapy in the advanced/metastatic setting and must have either progressed on or be intolerant of the certain agents.
  • Arm C: Patients with advanced NHL who have follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). Other subtypes of NHL may be considered after discussion with the Sponsor. All patients with NHL must have received at least 2 prior systemic therapies and have relapsed or refractory disease. Prior therapy with autologous Chimeric Antigen Receptor T-Cell (CAR-T) therapy is permitted and will be considered a prior line.
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  • Patients with follicular lymphoma (or other indolent lymphoma)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • At least one measurable lesion per RECIST 1.1 or evaluable lesion per Lugano classification.
  • Agrees to undergo a pre-treatment and on-treatment biopsy of a primary or metastatic tumor lesion.
  • Human immunodeficiency virus (HIV) infected patients must be on antiretroviral therapy (ART) and well-controlled HIV infection/disease
  • Has adequate organ and bone marrow function.
  • Willingness of men and women of reproductive potential to agree to highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug.

Who cannot join

  • A history of another active malignancy (a second cancer) within the previous 2 years, except for localized cancers that are not related to the current cancer being treated, is considered cured, and, in the opinion of the Investigator, presents a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Received prior treatment with IL-12 by any route of administration (including intratumoral injection).
  • Patients with primary CNS malignancies and CRPC
  • Have known symptomatic brain metastases requiring steroids.
  • Significant cardiovascular disease
  • Significant electrocardiogram (ECG) abnormalities
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  • Active autoimmune disease requiring systemic treatment in the past 2 years
  • Diagnosis of immunodeficiency, on immunosuppressive therapy, or receiving chronic systemic or enteric steroid therapy (dose > 10 mg/day of prednisone or equivalent)
  • Major surgery (excluding placement of vascular access) within 2 weeks prior to the first dose of study drug.
  • Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine, or other anticancer herbal remedy) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug.
  • Radiotherapy within 2 weeks of start of study treatment. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
  • Any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 1 at the time of starting study drug with the exception of alopecia Grade 2 platinum therapy-related neuropathy and Grade 2 endocrine immune-related AEs managed with a stable dose of hormone replacement therapy.
  • Use of sensitive substrates of major CYP450 isozymes.
  • Any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent form (ICF), adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.
  • Received a live vaccine within 30 days of the first dose of study drug.
  • Active systemic bacterial, viral, or fungal infection.
  • HIV-infected participants with a history of Kaposi sarcoma and/or multicentric Castleman Disease.
  • Active infection as determined by hepatitis B surface antigen and hepatitis B core antibody, or hepatitis B virus deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (qPCR) testing.
  • Active infection as determined by hepatitis C virus (HCV) antibody or HCV RNA by qPCR testing.
  • Pregnant or lactating.
  • History of hypersensitivity to any of the study drug components.
  • Additional criteria may apply

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Northwestern University

    Chicago, Illinois, 60611

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • NEXT Oncology

    San Antonio, Texas, 78229

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1b/2 Multisite Dose- and Regimen-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma (NHL)

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).

Being tested
WTX-330
Keywords
WTX-330, Cancer, Immunotherapy, Interleukin-12, IL-12, Checkpoint inhibitor resistance
Medical subject headings
Lymphoma, Non-Hodgkin, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WTX-330Drug

    Investigational Product

Study groups in NCT06939283
Study groupRoleWhat they receive
Dose- and Regimen FindingExperimentalRegimen 1 Fixed Dose for 28 days then Regimen 2 Step-up Dose for 28 days
Receives: Drug: WTX-330
Dose Expansion Arm AExperimentaln~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
Receives: Drug: WTX-330
Dose Expansion Arm BExperimentaln~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
Receives: Drug: WTX-330
Dose Expansion Arm CExperimentaln~20 Patients with advanced NHL who are relapsed/refractory to SOC therapies and who are CPI naïve
Receives: Drug: WTX-330

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLTs)

    Measured: 4 weeks

  2. Incidence of treatment emergent adverse events

    Measured: 24 months

  3. Incidence of changes in clinical laboratory abnormalities

    Measured: 24 months

  4. Overall response rate (ORR) by response evaluation criteria in solid tumors (RECIST) 1.1 and the immune-overall response rate (iORR) by immune RECIST (iRECIST; Part 2, Arms A and B) or response by Lugano classification (Part 2, Arm C)

    Measured: 24 months

  5. Duration of response (DOR) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)

    Measured: 24 months

Secondary outcomes (7)

  1. Characterize the plasma concentrations of WTX-330, free IL-12 and interferon gamma (IFNγ)

    Measured: 24 months

  2. Changes in PD-L1 expression in tumor biopsies

    Measured: 24 months

  3. Duration of response (DOR) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 1 and Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)

    Measured: 24 months

  4. Progression-free survival (PFS) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 1 and Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)

    Measured: 24 months

  5. Overall survival (OS) after treatment with WTX-330 in Part 2 based on death, start of new anticancer therapies, withdrawal of consent or lost to follow-up

    Measured: 36 months

  6. Incidence of WTX-330 antidrug antibodies

    Measured: 24 months

  7. Titers of WTX-330 antidrug antibodies

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2025
  2. Study start21 Apr 2025
  3. Primary completion23 Apr 2026
  4. Study completion23 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06939283
Sponsor's protocol ID
WTX-330x2102
Status last verified
Oct 2026
First submitted
26 Mar 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing WTX-330 in people with Advanced or Metastatic Solid Tumors and Non-Hodgkin Lymphoma, run by Werewolf Therapeutics, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLTs) (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06939283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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