WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
Lymphoma
Non-Hodgkin Lymphoma
18 Years and older, Male and Female
WTX-330x2101 (primary)
NCI-2023-00670
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.
Objectives
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.
Eligibility
- 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.
- 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.
Treatment Sites in Georgia
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