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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04505839
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : December 16, 2020
Sponsor:
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
ST Pharm Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 2, 2020
First Posted Date  ICMJE August 10, 2020
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE July 30, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
Dose limiting toxicities (DLTs) [ Time Frame: 28 days ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Treatment-emergent adverse events (TEAEs) [ Time Frame: 24 months ]
    Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0
  • The pharmacokinetics of STP1002 [ Time Frame: 24 months ]
    Plasma concentration of STP1002 following oral administration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
Official Title  ICMJE First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: STP1002
Oral capsule, QD
Study Arms  ICMJE Experimental: STP1002
Intervention: Drug: STP1002
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hugh Lee 2404213190 hughlee@kcrnresearch.com
Contact: Christine Lee Christinelee@kcrnresearch.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04505839
Other Study ID Numbers  ICMJE STP-ST-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ST Pharm Co., Ltd.
Study Sponsor  ICMJE ST Pharm Co., Ltd.
Collaborators  ICMJE KCRN Research, LLC
Investigators  ICMJE Not Provided
PRS Account ST Pharm Co., Ltd.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP