Clinical Trials /

First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors

NCT04505839

Description:

This is an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.

Related Conditions:
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Hepatocellular Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
  • Official Title: First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: STP-ST-01
  • NCT ID: NCT04505839

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
STP1002STP1002

Purpose

This is an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.

Trial Arms

NameTypeDescriptionInterventions
STP1002Experimental
  • STP1002

Eligibility Criteria

        Inclusion Criteria:

          -  Advanced-stage solid tumor (metastatic or locally advanced and unresectable) with
             histologically confirmed diagnosis of CRC, NSCLC, GC, RCC, or HCC

          -  Measurable lesion(s) according to RECIST 1.1 criteria

          -  Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.

          -  Ability to swallow capsules

          -  Received last chemotherapy, biologic, or investigational therapy at least 4 weeks
             prior to first dosing of study treatment

          -  Has received or is intolerant to all standard of care treatment options with known
             clinical benefit

          -  Life expectancy of more than 3 months

          -  Adequate hematological, hepatic and renal function

          -  For women of childbearing potential, a negative serum pregnancy test performed within
             7 days prior to start of treatment

        Exclusion Criteria:

          -  Received treatment within the last 28 days with a drug that has not received
             regulatory approval for any indication at the time of study entry

          -  Major surgery within the last 28 days prior to the first dose of investigational drug

          -  Prior radiation therapy within 14 days prior to study Cycle 1 Day 1 and/or persistence
             of radiation-related adverse effects.

          -  Concurrent treatment with any anticancer agent

          -  Currently taking either strong CYP inhibitors or inducers

          -  Known brain metastases, uncontrolled seizure disorder, or active neurologic disease

          -  Significant cardiovascular impairment

          -  Pregnant or nursing

          -  Known HIV infection, active hepatitis C and/or hepatitis B infection

          -  Known bleeding disorder or coagulopathy

          -  Active drug or alcohol abuse or history of alcohol or drug abuse during the last two
             years.

          -  Diagnosis of osteoporosis at the time of the screening

          -  Any history of retinal pathology including diabetic retinopathy, macular degeneration,
             or other retinal degenerative disease
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicities (DLTs)
Time Frame:28 days
Safety Issue:
Description:DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1

Secondary Outcome Measures

Measure:Treatment-emergent adverse events (TEAEs)
Time Frame:24 months
Safety Issue:
Description:Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0
Measure:The pharmacokinetics of STP1002
Time Frame:24 months
Safety Issue:
Description:Plasma concentration of STP1002 following oral administration

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ST Pharm Co., Ltd.

Last Updated

August 6, 2020