Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 10, 2020
Sponsor:
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
ST Pharm Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: STP1002 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: STP1002 Drug: STP1002
Oral capsule, QD




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. The pharmacokinetics of STP1002 [ Time Frame: 24 months ]
    Plasma concentration of STP1002 following oral administration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505839


Contacts
Layout table for location contacts
Contact: Hugh Lee 2404213190 hughlee@kcrnresearch.com
Contact: Christine Lee Christinelee@kcrnresearch.com

Locations
Layout table for location information
United States, California
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Hugh Lee       hughlee@kcrnresearch.com   
Principal Investigator: Heinz-Josef Lenz, MD         
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Hugh Lee       hughlee@kcrnresearch.com   
Principal Investigator: Christopher Lieu, MD         
United States, Illinois
Northwestern University Not yet recruiting
Evanston, Illinois, United States, 60208
Contact: Hugh Lee       hughlee@kcrnresearch.com   
Principal Investigator: Al Benson, MD         
Sponsors and Collaborators
ST Pharm Co., Ltd.
KCRN Research, LLC
Layout table for additonal information
Responsible Party: ST Pharm Co., Ltd.
ClinicalTrials.gov Identifier: NCT04505839    
Other Study ID Numbers: STP-ST-01
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms