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

Sponsor
ST Pharm Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04505839
Collaborator
KCRN Research, LLC (Industry)
30
Enrollment
3
Locations
1
Arm
19
Anticipated Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 30, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: STP1002

Drug: STP1002
Oral capsule, QD

Outcome Measures

Primary Outcome Measures

  1. Dose limiting toxicities (DLTs) [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) [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 [24 months]

    Plasma concentration of STP1002 following oral administration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern California Los Angeles California United States 90033
2 University of Colorado Denver Denver Colorado United States 80045
3 Northwestern University Evanston Illinois United States 60208

Sponsors and Collaborators

  • ST Pharm Co., Ltd.
  • KCRN Research, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ST Pharm Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04505839
Other Study ID Numbers:
  • STP-ST-01
First Posted:
Aug 10, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Sep 28, 2021