RecruitingCancerSolid TumorMelanoma
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.
Sponsor: Simcha IL-18, Inc.
You may qualify if…
- ✓ 1. Male and female patients aged ≥18 years
- ✓ 2. Must provide written informed consent and any authorizations required by local law
- ✓ 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- ✓ 4. Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor
- ✓ For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma and platinum resistant ovarian cancer.
- ✓ 1. For patients who have developed disease progression through standard therapy, or
- ✓ 2. For patients whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the investigator and after consultation with the Medical Monitor) For Phase 1 combination therapy dose escalation, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions), TNBC, SCCHN, MSI-Hi tumors, Hi TMB or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, and HCC
- ✓ TNBC is diagnosed in a tumor which does not express estrogen receptor or progesterone receptor, is not human epidermal growth factor receptor 2 (HER2) 3+ on IHC or is negative by fluorescence in situ hybridization (FISH).
You may not qualify if…
- ✕ 1. History of another malignancy
- ✕ 2. Known symptomatic brain metastases requiring \>10 mg/day of prednisolone or equivalent
- ✕ 3. Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2 monotherapy only) including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular block type II, third degree AV
- ✕ 4. Any degree of respiratory compromise (from either malignant or non-malignant disease)
- ✕ 5. Evidence of an ongoing systemic bacterial, fungal, or viral infection
- ✕ 6. Has received a live vaccine within 30 days
- ✕ 7. Major surgery within 4 weeks
- ✕ 8. Prior solid organ or bone marrow progenitor cell transplantation
Where it's recruiting
Source: ClinicalTrials.gov · NCT04787042 · last updated 2024-11-15