About the study

This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of ST-067, and a Phase 1 open-label and dose escalation study of ST-067 in combination with pembrolizumab. The Phase 2 study is not enrolling at this time. Phase 1a is a first-in-human (FIH) dose escalation study in patients aged 18 years or older diagnosed with solid tumors who have exhausted available standard therapy. The Phase 1 dose escalation in combination with pembrolizumab is designed to determine the RP2D of ST-067 administered as a SC injection QW in combination with pembrolizumab infusion.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

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.
5. For patients who have developed disease progression through standard therapy, or
6. 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 2, the following solid tumors are allowed: Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors
7. Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation
8. Has an accessible tumor for biopsy pre
9. and on-treatment (mandatory).

Exclusion criteria

1. History of another malignancy
2. Known symptomatic brain metastases requiring >10 mg/day of prednisolone
3. Significant cardiovascular disease
4. Significant ECG abnormalities
5. Any degree of respiratory compromise (from malignant or non-malignant disease)
6. Evidence of an ongoing systemic bacterial, fungal, or viral infection
7. Has received a live vaccine within 30 days
8. Major surgery within 4 weeks
9. Prior solid organ or bone marrow progenitor cell transplantation
10. Prior high dose chemotherapy requiring stem cell rescue
11. History of active autoimmune disorders
12. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids.
13. Treatment with an approved, systemic anticancer therapy or an investigational agent within 4 weeks of Day 1

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.