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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505839
• Other study ID #: STP-ST-01
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2020
• Est. completion date: March 10, 2023

Study information

• Verified date: January 2024
• Source: ST Pharm Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• STP1002
Oral capsule, QD

Locations

Country	Name	City	State
United States	University of Colorado Denver	Denver	Colorado
United States	Northwestern University	Evanston	Illinois
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
ST Pharm Co., Ltd.	KCRN Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicities (DLTs)	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	28 days
Secondary	Treatment-emergent adverse events (TEAEs)	Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0	24 months
Secondary	The pharmacokinetics of STP1002	Plasma concentration of STP1002 following oral administration	24 months