Clinical Trials /

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

NCT04787042

Description:

This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of ST-067. 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. Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and microsatellite instability-high tumors.

Related Conditions:
  • Breast Carcinoma
  • Cervical Carcinoma
  • Endometrial Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Melanoma
  • Merkel Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Renal Cell Carcinoma
  • Small Cell Lung Carcinoma
  • Squamous Cell Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04787042

Trial Eligibility

Document

Title

  • Brief Title: Phase 1a and Phase 2 Study for PK, PD, Safety and Preliminary Efficacy of ST-067
  • Official Title: A Phase 1a Open-Label, Dose-Escalation, and a Phase 2 Study to Investigate the Safety, PK, PD, and Clinical Activity of ST-067 Administered Subcutaneously as Monotherapy in Patients With Relapsed or Refractory Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: ST-067-001
  • NCT ID: NCT04787042

Conditions

  • Cancer
  • Solid Tumor
  • Melanoma
  • Renal Cell Carcinoma
  • Triple-negative Breast Cancer
  • Non Small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma

Interventions

DrugSynonymsArms
ST-067Phase 1a, Dose Escalation

Purpose

This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of ST-067. 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. Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and microsatellite instability-high tumors.

Detailed Description

      Phase 1a is designed to determine the recommended Phase 2 dose of ST-067 monotherapy using a
      modified toxicity probability interval (mTPI) design. ST-067 is administered as subcutaneous
      injection once weekly. Pre and on treatment biopsies will be mandated for all patients. There
      will be evaluation of PK and PD effects.

      Phase 2 will evaluate the preliminary efficacy of ST-067 administered at the RP2D to patients
      with the following tumor types. A Simon 2 stage design is used to calculate the sample size
      and early stopping rules will be employed in the event of lack of efficacy in any of the
      cohorts. RECIST 1.1 will be used to assess tumor response every 8-12 weeks.

        -  Melanoma (n=28)

        -  Renal cell carcinoma (n=25)

        -  Triple-negative best cancer (n=25)

        -  Non-small cell lung cancer (n=25)

        -  squamous cell carcinoma of the head and neck (n=28)

        -  MSI-Hi tumors (n=25)

      Safety will be assessed for each patient throughout the study.

Trial Arms

NameTypeDescriptionInterventions
Phase 1a, Dose EscalationExperimentalIn phase 1 dose escalation will start at a dose level of 30ug/kg . Patients will be treated every week and the DLT evaluation period is 28 days. According to the mTPI schema initially there will be 2 patients per cohort until the first DLT is observed at which point cohorts will be expanded according to the predetermined mTPI design. Up to 12 patients will be treated at the RP2D
  • ST-067
Phase 2, ExpansionExperimentalPhase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and microsatellite instability-high (MSI-Hi) tumors at the RP2D.
  • ST-067

Eligibility 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.

               1. For patients who have developed disease progression through standard therapy, or

               2. For patients whom standard of care therapy that prolongs survival is not
                  available or suitable (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

          5. Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied
             or received prior irradiation

          6. Has an accessible tumor for biopsy pre- 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 i

          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

          9. Prior high dose chemotherapy requiring stem cell rescue

         10. History of active autoimmune disorders

         11. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the maximum tolerated dose of ST-067 in phase 1a
Time Frame:Day 29
Safety Issue:
Description:6 to 12 patients have been enrolled at a dose level that is predicted to be the MTD

Secondary Outcome Measures

Measure:PK
Time Frame:Day 29
Safety Issue:
Description:Peak Plasma Concentration (Cmax)
Measure:ADA
Time Frame:Day 29
Safety Issue:
Description:Incidence of ADA to ST-067

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Simcha IL-18, Inc.

Last Updated

July 29, 2021