Loading clinical trials...

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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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 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)

NCT06939283•Werewolf Therapeutics, Inc.

View on ClinicalTrials.gov

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. 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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years,
•2. 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.
•3. 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.
•* Patients with follicular lymphoma (or other indolent lymphoma)
•4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•5. At least one measurable lesion per RECIST 1.1 or evaluable lesion per Lugano classification.
•6. Agrees to undergo a pre-treatment and on-treatment biopsy of a primary or metastatic tumor lesion.
+3 more criteria

Exclusion Criteria

•1. 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.
•2. Received prior treatment with IL-12 by any route of administration (including intratumoral injection).
•3. Patients with primary CNS malignancies and CRPC
•4. Have known symptomatic brain metastases requiring steroids.
•5. Significant cardiovascular disease
•6. Significant electrocardiogram (ECG) abnormalities
•7. Active autoimmune disease requiring systemic treatment in the past 2 years
•8. Diagnosis of immunodeficiency, on immunosuppressive therapy, or receiving chronic systemic or enteric steroid therapy (dose \> 10 mg/day of prednisone or equivalent)
•9. Major surgery (excluding placement of vascular access) within 2 weeks prior to the first dose of study drug.
•10. 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.
+12 more criteria

Locations (5)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

NEXT Oncology

San Antonio, Texas, United States

Key Dates

Start Date

May 7, 2025

Primary Completion Date

August 1, 2028

Completion Date

August 1, 2028

Last Updated

February 10, 2026

Enrollment

100

ESTIMATED participants

Conditions

Advanced or Metastatic Solid TumorsNon-Hodgkin Lymphoma

Interventions

WTX-330

DRUG

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

View study

RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma