CompletedPhase 1

WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma

United States25 participantsStarted 2022-12-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. HIV-infected patients must be on antiretroviral therapy and have well-controlled disease.
✓. Adequate organ and bone marrow function.

Exclusion criteria

✕. 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
✕. 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).

What they're measuring

Incidence of Dose Limiting Toxicities (DLTs)

Timeframe: 4 weeks

Incidence of Treatment Emergent Adverse Events

Timeframe: 24 months

Incidence of Changes in Clinical Laboratory Abnormalities

Timeframe: 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)

Timeframe: 24 months

Trial details

NCT IDNCT05678998

SponsorWerewolf Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-23

Results submitted2025-09-22

View on ClinicalTrials.gov More Advanced or Metastatic Solid Tumors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. HIV-infected patients must be on antiretroviral therapy and have well-controlled disease.
✓. Adequate organ and bone marrow function.

Exclusion criteria

✕. 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
✕. 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).

What they're measuring

Incidence of Dose Limiting Toxicities (DLTs)

Timeframe: 4 weeks

Incidence of Treatment Emergent Adverse Events

Timeframe: 24 months

Incidence of Changes in Clinical Laboratory Abnormalities

Timeframe: 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)

Timeframe: 24 months