Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizum… (NCT05479812) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid Tumors
United States150 participantsStarted 2022-05-20
Plain-language summary
A first-in-human, Phase I, open-label, multicenter study of WTX-124 administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic solid tumors.
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
✓. Has histological or cytological documentation of a solid tumor indication for which a CPI (e.g. anti-PD-(L)1 is indicated for all parts of the clinical study;
✓. Monotherapy Dose Escalation:
✓. Arm D: Patients with RCC who have received no more than 3 prior lines of therapy
✓. Arm E: Patients with cutaneous melanoma who may be naïve to all prior therapy for advanced or metastatic disease. For BRAF wild type melanoma, patients should have received no more than 2 prior lines of therapy. For BRAF V600 mutant disease, patients should have received no more than 3 prior lines of therapy.
✓. Arm F: Patients with PD-L1-positive NSCLC who have received no more than 3 prior lines;
✓. ≥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 previously irradiated area are considered measurable if progression has been demonstrated in such lesions);
Exclusion criteria
✕. Have 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, are 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;
What they're measuring
1
Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Timeframe: 4 weeks
2
Incidence of treatment emergent adverse events in monotherapy and combination therapy
Timeframe: 24 months
3
Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Timeframe: 24 months
4
Dose Expansion - Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Timeframe: 4 weeks
5
Dose Expansion - Incidence of treatment emergent adverse events in monotherapy and combination therapy
Timeframe: 24 months
6
Dose Expansion - Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Timeframe: 24 months
7
Dose Expansion - Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required 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 2 years;
✕. Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving chronic systemic or enteric steroid therapy