RecruitingPhase 1

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

United States, China276 participantsStarted 2020-01-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Known allergy or hypersensitivity to any component of the investigational drug product
✕. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）
✕. Others

What they're measuring

Incidence of DLTs

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Incidence and Severity of AEs

Timeframe: Through study completion, an average of 6 months

Trial details

NCT IDNCT04192344

SponsorAbbisko Therapeutics Co, Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

YUAN LU

+86-21-68910052 clinical@abbisko.cn

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