Clinical Trial 21340

• Overview

  Study Title:

  A First-In-Human, Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 With or Without Obinutuzumab Pre-treatment, and ST-067 in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies

  Summary:

  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.

  Objective:

  Phase 1a and 2 Monotherapy Primary Objectives: The primary Phase 1a monotherapy objectives are: To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ST-067, administered by subcutaneous (SC) or intravenous (IV) dosing, in subjects with relapsed or refractory solid tumors To determine the MTD and RP2D of ST-067, administered SC after 1 cycle of pre-treatment with obinutuzumab (Gazyva®) in subjects with relapsed or refractory solid tumors The primary Phase 2 monotherapy objective is: To evaluate the anti-tumor activity of ST-067 at the RP2D in the selected relapsed solid tumor cohorts (with or without obinutuzumab pre-treatment, depending on preliminary results) Secondary Objectives: The secondary objectives for Phase 1a (for both SC and IV dosing options and for 1 cycle of pre-treatment with obinutuzumab) and Phase 2 monotherapy are: To evaluate the overall safety and tolerability of ST-067 as a single agent To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ST-067 as a single agent To evaluate the antitumor activity of ST-067: - Objective response rate (ORR; Phase 1a monotherapy only) - Duration of response (DOR) of ST-067 - Disease control rate (DCR) - Time to response (TTR) - Progression free survival (PFS) - Overall survival (OS) Phase 1 Combination Therapy Primary Objectives: To evaluate the overall safety and tolerability of SC ST-067 in combination with pembrolizumab To determine the MTD and RP2D of ST-067 in combination with pembrolizumab in subjects with insufficient response to a checkpoint inhibitor programmed cell death receptor-1 (PD-1) therapy Secondary Objectives: To characterize the PK and PD profiles of ST-067 with pembrolizumab To confirm the overall safety and tolerability of ST-067 in combination with pembrolizumab in subjects with platinum resistant ovarian cancer and microsatellite stable colorectal cancer who have not had prior exposure to a checkpoint inhibitor To evaluate the antitumor activity of the combination therapy

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS)

  Medications:

  Obinutuzumab (); Pembrolizumab (Keytruda); ST-067 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Male and female patients over 18 years of age.
  • 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. (a) For patients who have developed disease progression through standard therapy, or (b) 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
  • Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation
  • Has an accessible tumor for biopsy pre- and on-treatment (mandatory).
  • Other criteria may apply

• Exclusion Criteria

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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.