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NCT04787042

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

Recruiting · Phase 1, Phase 2 · Simcha IL-18, Inc. · registry updated 2024-11-15

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

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.

Inclusion

  • Male and female patients aged ≥18 years
  • Must provide written informed consent and any authorizations required by local law
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 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.
  • For patients who have developed disease progression through standard therapy, or

Exclusion

  • History of another malignancy
  • Known symptomatic brain metastases requiring \>10 mg/day of prednisolone or equivalent
  • 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
  • Any degree of respiratory compromise (from either malignant or non-malignant disease)
  • Evidence of an ongoing systemic bacterial, fungal, or viral infection
  • Has received a live vaccine within 30 days

Open NCT04787042 on ClinicalTrials.govAll conditions