A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

Neoplasms Clinical Trial

Official title:

A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192344
• Other study ID #: ABSK021-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 20, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Abbisko Therapeutics Co, Ltd
• Contact: YUAN LU
• Phone: +86-21-68910052
• Email: clinical[@]abbisko.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

Description:

The study will start with a dose escalation part of single-agent ABSK021 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for further evaluating safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists

• ECOG (electrocorticogram) performance status 0~1

• Life expectancy = 3 months

• Adequate organ function and bone marrow function

For patients with tenosynovial giant cell tumor (TGCT) :

1. A diagnosis of TGCT [i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);

2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;

3. Others

Exclusion Criteria:

• Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors

• Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment

• Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication

• Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within = 5-halflife or = 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)

• Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence

• Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade =2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo

• Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug

• Concomitant use of strong inhibitors or inducers of CYP3A4

• Active central nervous system (CNS) metastases

• Impaired cardiac function or clinically significant cardiac disease

• Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study

• Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection

• Refractory/uncontrolled ascites or pleural effusion

• Pregnant or nursing

For patients with tenosynovial giant cell tumor (TGCT) :

1. Known allergy or hypersensitivity to any component of the investigational drug product

2. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US)

3. Others

Related Conditions & MeSH terms

• Giant Cell Tumor of Tendon Sheath
• Giant Cell Tumors
• Neoplasms
• Tenosynovial Giant Cell Tumor

Intervention

Drug:
• ABSK021
ABSK021 oral capsule

Locations

Country	Name	City	State
United States	The Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Precision NextGen Oncology	Beverly Hills	California
United States	SCRI at HealthOne	Denver	Colorado
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbisko Therapeutics Co, Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLTs	DLT(dose-limiting toxicity)	At the end of Cycle 1 (each cycle is 28 days)
Primary	Incidence and Severity of AEs	Adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)	Through study completion, an average of 6 months
Secondary	PFS	Progression-Free Survival (PFS)	From date of enrollment until the date of first documented progression or death, assessed up to 12 months
Secondary	DoR	Duration of Response (DoR)	From date of enrollment until the date of first documented progression or death, assessed up to 12 months
Secondary	DCR	Disease Control Rate (DCR)	24 weeks post-dose
Secondary	Cmax	The peak plasma concentration of a drug after administration	Pre-dose and multiple timepoints (up to 72 hours) post-dose
Secondary	tmax	Time to reach Cmax	Pre-dose and multiple timepoints (up to 72 hours) post-dose
Secondary	Bioavailability	The systemically available fraction of a drug	Pre-dose and multiple timepoints (up to 72 hours) post-dose
Secondary	Elimination half-life	The time required for the concentration of the drug to reach half of its original value	Pre-dose and multiple timepoints (up to 72 hours) post-dose