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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Abbisko Therapeutics Co, Ltd
Study ID
NCT04192344
Phase
PHASE1
Status
Recruiting
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Conditions

  • Neoplasms
  • Tenosynovial Giant Cell Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABSK021 — DRUG
    ABSK021 oral capsule

Study Details

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.

Key Dates

Start date
Jan 20, 2020
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
276 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ABSK021
    Dose escalation of oral ABSK021 with a starting dose of 25mg once daily will be guided by"3+3" escalation rules based on safety data until an MTD has been identified or a RDE. For each dose, patients will first receive a single dose ABSK021 tablet(s) by mouth at Day -3 and be followed by a 3-day off as a run-in period to access the safety and PK of single-dose. Then, patients will continuously receive ABSK021 once daily (QD) in repeated 28-day cycles.

Primary Outcome Measure

Incidence of DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Precision NextGen OncologyBeverly HillsCalifornia90212-
SCRI at HealthOneDenverColorado80218-1238-
The Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Beverly Hills, CA

By research site
Precision NextGen Oncology· Beverly Hills, CASCRI at HealthOne· Denver, COThe Winship Cancer Institute of Emory University· Atlanta, GAMD Anderson Cancer Center· Houston, TX

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