Advanced or Metastatic Solid TumorsPhase 1NCT05678998
WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
A Phase 1 study testing WTX-330 in people with Advanced or Metastatic Solid Tumors and Non-Hodgkin Lymphoma, run by Werewolf Therapeutics, Inc. at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors, Non-Hodgkin Lymphoma
- What is being tested?
- WTX-330
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 Dec 2022to 5 Feb 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: A diagnosis of a relapsed/refractory 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.
- Dose Expansion: A diagnosis of a relapsed/refractory advanced or metastatic malignancy for which the patient has progressed on or is intolerant of standard therapy, or for whom no standard therapy with proven benefit exists. For Arm A, patients must have a tumor type for which a CPI is indicated/approved and demonstrate primary or secondary resistance to a standard of care anti-PD(L)1-based treatment regimen. For Arm B, patients must have a solid tumor type for which a CPI is not indicated/approved or non-Hodgkin lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- At least one measurable lesion per RECIST 1.1 or an evaluable lesion per Lugano classification (for lymphoma).
- Agrees to undergo a pre-treatment and on-treatment biopsy of a primary or metastatic solid tumor or lymphoma lesion.
Show all 10Show fewer
- HIV-infected patients must be on antiretroviral therapy and have well-controlled disease.
- Adequate organ and bone marrow function.
- Willingness of men and women of reproductive potential to use highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug.
- Additional criteria may apply.
Who cannot join
- A history of another active malignancy (i.e., a second cancer) within the previous 2 years, except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, present 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, including by intratumoral injection.
- Patients with primary CNS malignancies.
- Presence of CNS metastases that are symptomatic and/or require local CNS directed therapy (such as XRT or surgery) or increasing doses of corticosteroids within 2 weeks prior to the first dose of study drug. Patients with treated brain metastases should be neurologically stable and receiving ≤ 10 mg per day of prednisone or equivalent prior to study entry.
- Significant cardiovascular disease.
- Significant electrocardiogram (ECG) abnormalities
Show all 23Show fewer
- 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).
- Prior receipt of an allogeneic stem cell transplant or allogeneic CAR-T cell therapy.
- 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 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 the 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 NCI-CTCAE version 5.0 Grade 1 at the time of starting study drug with the exception of alopecia and Grade 2 platinum therapy-related neuropathy.
- Use of sensitive substrates of major CYP450 isozymes.
- Any illness, medical condition, organ system dysfunction, or social situation (including mental illness or substance abuse), that may interfere with a patient's ability to sign the ICF, adversely affect the patient's ability to cooperate and participate in the study, or compromise interpretation of study results.
- Received a live vaccine within 30 days of the first dose of study drug.
- Active, uncontrolled systemic bacterial, viral, or fungal infection.
- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Active infection with hepatitis B 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 with hepatitis C 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
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Mass General Hospital
Boston, Massachusetts, 02114
Facility Name: Roswell Park Comprehensive Cancer Care
Buffalo, New York, 14203
Northwestern University
Chicago, Illinois, 60611
Indiana University
Indianapolis, Indiana, 46202
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
NEXT Oncology
San Antonio, Texas, 78229
HonorHealth
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 (First-In-Human [FIH]), Multi-Site, Dose Escalation and Expansion Study of WTX-330 in Adult Patients With Advanced or Metastatic Solid Tumors or Lymphoma
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.
Read the detailed description
This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety, tolerability and preliminary efficacy of WTX-330, a conditionally-activated IL-12 prodrug, when administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. Dose escalation will be conducted in patients with advanced and/or metastatic solid tumors who are refractory to all standard of care therapies. Dose expansion will be conducted in two arms: Arm A will enroll patients with indications for which a checkpoint inhibitor (CPI) is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1 treatment regimen, and Arm B will enroll patients with tumor types for which CPI therapy is not indicated/approved.
- 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
Investigation Product
| Study group | Role | What they receive |
|---|---|---|
| WTX-330 dose escalation | Experimental | Patients with relapsed/refractory advanced or metastatic solid tumors Receives: Drug: WTX-330 |
| WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A) | Experimental | 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 Receives: Drug: WTX-330 |
| WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B) | Experimental | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved Receives: Drug: WTX-330 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)
A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with WTX-330 and meets any of the criteria included in the protocol
Measured: 4 weeks
Incidence of Treatment Emergent Adverse Events
AEs were graded and documented in accordance with NCI-CTCAE version 5.0
Measured: 24 months
Incidence of Changes in Clinical Laboratory Abnormalities
Change from baseline is provided as baseline grade or "normal/low/high" and worst post-baseline grade.
Measured: 24 months
Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas)
RECIST = Response Evaluation Criteria in Solid Tumors
Measured: 24 months
Secondary outcomes (17)
Plasma Concentrations of WTX-330 Cycle 1 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Measured: 14 days
Plasma Concentrations of WTX-330 Cycle 2 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Measured: 14 days
Plasma Concentrations of IL-12 Cycle 1 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Measured: 14 days
Plasma Concentrations of IL-12 Cycle 2 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Measured: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Measured: 14 days
Antidrug Antibody (ADA) Occurrence
ADA were measured at Baseline and Post Baseline. "Positive" post baseline applies if at least one post-baseline value was positive.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start6 Dec 2022
- Primary completion23 Dec 2024
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Werewolf Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678998
- Sponsor's protocol ID
- WTX-330x2101
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2022
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 (First-In-Human [FIH]), Multi-Site, Dose Escalation and Expansion Study of WTX-330 in Adult Patients With Advanced or Metastatic Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT05678998
- Acronym / sponsor ID
- WTX-330x2101
- Keywords
- WTX-330, Cancer, Immunotherapy, Interleukin-12, IL-12, Checkpoint inhibitor resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Werewolf Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety, tolerability and preliminary efficacy of WTX-330, a conditionally-activated IL-12 prodrug, when administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. Dose escalation will be conducted in patients with advanced and/or metastatic solid tumors who are refractory to all standard of care therapies. Dose expansion will be conducted in two arms: Arm A will enroll patients with indications for which a checkpoint inhibitor (CPI) is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1 treatment regimen, and Arm B will enroll patients with tumor types for which CPI therapy is not indicated/approved.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WTX-330 dose escalation | Experimental | Drug: WTX-330Patients with relapsed/refractory advanced or metastatic solid tumors |
| WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A) | Experimental | Drug: WTX-330WTX-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 |
| WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B) | Experimental | Drug: WTX-330WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Dose Escalation: A diagnosis of a relapsed/refractory 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.
- Dose Expansion: A diagnosis of a relapsed/refractory advanced or metastatic malignancy for which the patient has progressed on or is intolerant of standard therapy, or for whom no standard therapy with proven benefit exists. For Arm A, patients must have a tumor type for which a CPI is indicated/approved and demonstrate primary or secondary resistance to a standard of care anti-PD(L)1-based treatment regimen. For Arm B, patients must have a solid tumor type for which a CPI is not indicated/approved or non-Hodgkin lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- At least one measurable lesion per RECIST 1.1 or an evaluable lesion per Lugano classification (for lymphoma).
Key exclusion criteria (23 listed)
- A history of another active malignancy (i.e., a second cancer) within the previous 2 years, except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, present 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, including by intratumoral injection.
- Patients with primary CNS malignancies.
- Presence of CNS metastases that are symptomatic and/or require local CNS directed therapy (such as XRT or surgery) or increasing doses of corticosteroids within 2 weeks prior to the first dose of study drug. Patients with treated brain metastases should be neurologically stable and receiving ≤ 10 mg per day of prednisone or equivalent prior to study entry.
- Significant cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WTX-330Investigation Product | Drug | WTX-330 dose escalation, WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A), WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B) |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 4 weeks
A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with WTX-330 and meets any of the criteria included in the protocol
Incidence of Treatment Emergent Adverse Events
Time frame: 24 months
AEs were graded and documented in accordance with NCI-CTCAE version 5.0
Incidence of Changes in Clinical Laboratory Abnormalities
Time frame: 24 months
Change from baseline is provided as baseline grade or "normal/low/high" and worst post-baseline grade.
Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas)
Time frame: 24 months
RECIST = Response Evaluation Criteria in Solid Tumors
17 secondary outcomes
Plasma Concentrations of WTX-330 Cycle 1 - C Max
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - Time of Maximum Concentration Observation
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - Half Life
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - AUC
Time frame: 14 days
Plasma Concentrations of WTX-330 Cycle 2 - C Max
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - Time of Maximum Concentration Observation
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - Half Life
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - AUC
Time frame: 14 days
Plasma Concentrations of IL-12 Cycle 1 - C Max
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - Time of Maximum Concentration Observation
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - Half Life
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - AUC
Time frame: 14 days
Plasma Concentrations of IL-12 Cycle 2 - C Max
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - Time of Maximum Concentration Observation
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - Half Life
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - AUC
Time frame: 14 days
Antidrug Antibody (ADA) Occurrence
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WTX-330 in people with Advanced or Metastatic Solid Tumors and Non-Hodgkin Lymphoma, run by Werewolf Therapeutics, Inc. at 9 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 10 inclusion and 23 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.