WTX-330 dose escalation for Advanced or Metastatic Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced or Metastatic Solid Tumors+1 MoreWTX-330 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Advanced or Metastatic Solid Tumors
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

4 Primary · 10 Secondary · Reporting Duration: 36 months

24 months
Antidrug antibody (ADA) occurrence
Changes in circulating immune cell populations
Changes in soluble cytokines including IL-2, IL-4, IL-6, IL-10, IFN-γ and IP-10
Changes in tumor immune cell profile by immunohistochemistry (IHC)
Duration of response
Identification of potential biomarkers of target engagement and immune pathway activation in tumor biopsies
Incidence of changes in clinical laboratory abnormalities
Incidence of treatment emergent adverse events
Investigator-assessed ORR by RECIST 1.1 and immune ORR by iRECIST (for solid tumors) or response by Lugano criteria (for lymphomas) in patients who have progressed on CPIs or who have tumor indications for which CPIs are not approved
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)
Plasma concentrations of WTX-330 and free IL-12
Progression free survival
36 months
Overall survival
4 weeks
Incidence of Dose Limiting Toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

3 Treatment Groups

WTX-330 dose escalation
1 of 3
WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A)
1 of 3
WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B)
1 of 3

Experimental Treatment

75 Total Participants · 3 Treatment Groups

Primary Treatment: WTX-330 dose escalation · No Placebo Group · Phase 1

WTX-330 dose escalation
Drug
Experimental Group · 1 Intervention: WTX-330 · Intervention Types: Drug
WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A)
Drug
Experimental Group · 1 Intervention: WTX-330 · Intervention Types: Drug
WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B)
Drug
Experimental Group · 1 Intervention: WTX-330 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Werewolf Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years of age or older.
You have a relapsed/refractory advanced or metastatic solid tumor that has progressed despite standard therapy, or for which no beneficial standard treatment exists.
You have a relapsed/refractory advanced or metastatic malignancy that has progressed on, or is intolerant of standard therapy, and for which no other treatment with proven benefit exists
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You have at least one measurable lesion per RECIST 1.1 or an ascertainable lesion per Lugano classification (for lymphoma).
You consent to having a pre-treatment and post-treatment biopsy of any solid tumor or lymphoma lesion.
HIV-positive individuals must be taking antiretroviral medications and have a stabilized condition.
Your organs and bone marrow are functioning properly.
Men and women of reproductive potential must be willing to use highly effective contraception during treatment and for 4 months after the final dose of medicine.
There may be additional requirements.