Dose Escalation Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid Tumors
M
Mateusz Opyrchal, MD, PhD
Primary Investigator
Overview
A first-in-human, Phase I, open-label, multicenter study of WTX-124 administered asherapy and in combination with pembrolizumab to patients with advanced solid tumors.
Description
This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate they, tolerability and preliminary efficacy of WTX-124, a conditionally-activated IL-2drug, when administered as monotherapy and in combination with pembrolizumab, for thewith advanced solid tumors. Part 1 of the study is dose escalation of
WTX-124, both as monotherapy and in combination with pembrolizumab. Part 2 is comprised ofur arms in which WTX-124 will be administered as monotherapy and in combination withbrolizumab to patients with advanced or metastatic cutaneous malignant melanoma ordvanced or metastatic renal cell carcinoma.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Metastatic Solid Tumor, Advanced Solid Tumor
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Age: 18 Years
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Gender: All
Inclusion Criteria:
Each patient must meet all the following criteria to participate in the study:
- Has histological or cytological documentation of a solid tumor indication for which aCPI (e.g. anti-PD-(L)1 is indicated for all parts of the clinical study;
- ≥18 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Has at least 1 measurable lesion per RECIST 1.1(lesions situated in a previouslydiated area are considered measurable if progression has been demonstrated in such);
- Agrees to undergo a pre-treatment and on-treatment biopsy of a primary or metastaticd tumor lesion;
- Has adequate organ and bone marrow function:
- Willingness of men and women of reproductive potential to observe highly effectivebirth control for the duration of treatment and for 4 months following the last doseudy drug;
- Additional criteria may apply
Exclusion Criteria:
- Have a history of another active malignancy (a second cancer) within the previous 2years except for localized cancers that are not related to the current cancer beingd, are considered cured, and, in the opinion of the Investigator, presents a lowk of recurrence. These exceptions include, but are not limited to, basal orquamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of thevix, or breast;
- Has a history of (non-infectious) pneumonitis / interstitial lung disease thatquired steroids or has current pneumonitis / interstitial lung disease;
- Have received prior IL-2-directed therapy;
- Have had an allogeneic tissue/solid organ transplant;
- Have known symptomatic brain metastases requiring steroids;
- Have significant cardiovascular disease;
- Have an active autoimmune disease that required systemic treatment in the past 2years;
- Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receivinghronic systemic or enteric steroid therapy
- Major surgery (excluding placement of vascular access) within 2 weeks prior to thedose of study drug;
- Investigational agent or anticancer therapy within 5 half-lives or 4 weeks (whicheverhorter) prior to the first dose of study drug;
- Has received prior radiotherapy within 2 weeks of start of study treatment. A 1-weekwashout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNSdisease;
- Any unresolved toxicities from prior therapy greater than NCI CTCAE version 5.0 Grade1 at the time of starting study drug with the exception of alopecia and Grade 2 priorum-therapy related neuropathy;
- Received a live or live-attenuated vaccine within 30 days of the first dose of studydrug; Note: Administration of killed vaccines or other formats are allowed.
- Active, uncontrolled systemic bacterial, viral, or fungal infection;
- HIV-infected participants with a history of Kaposi sarcoma and/or MulticentricCastleman Disease;
- Active infection as determined by hepatitis B surface antigen and hepatitis B corebody, or hepatitis B virus DNA by quantitative polymerase chain reaction (qPCR)g;
- Active infection as determined by hepatitis C virus (HCV) antibody or HCV RNA by qPCRg;
- Pregnant or lactating;
- History of hypersensitivity to any of the study drug components;
- Additional criteria may apply.
Updated on
29 Apr 2024.
Study ID: WTX-124x2101
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