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ABSK-021 for Cancer

Phase 1
Recruiting
Led By Siqing Fu, MD
Research Sponsored by Abbisko Therapeutics Co, Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
Adequate organ function and bone marrow function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment until the date of first documented progression or death, assessed up to 12 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works well against cancer.

Who is the study for?
This trial is for adults with advanced solid tumors, including Giant Cell Tumor of the tendon sheath or pigmented villonodular synovitis, who have tried other treatments without success or can't undergo surgery. Participants must be able to swallow pills, not have had recent cancer treatment or major surgery, and should not be pregnant or nursing.Check my eligibility
What is being tested?
The study tests ABSK-021, an oral medication for advanced solid tumors. It's an early-phase trial to find out how safe it is and what dose works best. Researchers will also look at any signs that the drug might shrink the tumors.See study design
What are the potential side effects?
Since this is a phase 1 trial primarily assessing safety and tolerability, specific side effects are being investigated but may include typical reactions such as nausea, fatigue, allergic responses to ingredients in ABSK-021, liver function changes among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with a solid tumor that has either gotten worse despite standard treatment or for which there is no standard treatment available.
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Your organs and bone marrow are working properly.
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There may be additional criteria that are not listed here.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until the date of first documented progression or death, assessed up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until the date of first documented progression or death, assessed up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of AEs
Incidence of DLTs
Secondary outcome measures
Bioavailability
Cmax
DCR
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABSK021Experimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Abbisko Therapeutics Co, LtdLead Sponsor
17 Previous Clinical Trials
1,182 Total Patients Enrolled
Siqing Fu, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this research endeavor?

"Affirmative. As evidenced by information on clinicaltrials.gov, this medical investigation has been actively recruiting since 20th January 2020 and last updated 25th July 2022. Eighty-five patients are being sought from three different centres of research."

Answered by AI

Is there still an opportunity to join this experiment?

"As per the clinicaltrials.gov listing, this research endeavor is currently in search of participants since its initial posting on January 20th 2020 and most recent edit on July 25th 2022."

Answered by AI

Has ABSK021 obtained the regulatory seal of approval from the US Food and Drug Administration?

"Due to the limited clinical data available, ABSK021 is assessed as having a safety rating of 1. This assessment derives from it being classified in Phase 1 of this medical trial."

Answered by AI

What is the primary objective of this experiment?

"Over the study's 6-month duration, the primary outcome of interest is to measure Incidence of DLTs. Secondary outcomes include Disease Control Rate (DCR), Progression-Free Survival (PFS), and Duration of Response (DoR)."

Answered by AI
~16 spots leftby Mar 2025