What side effects are associated with this type of intervention?

Common treatments for tumors, including investigational drugs like ABSK021, often have a range of side effects. Chemotherapy agents such as gemcitabine and oxaliplatin can cause neuropathy, fatigue, nausea, vomiting, diarrhea, and hematologic toxicities like neutropenia and anemia. Targeted therapies, such as masitinib and olaparib, may lead to manageable but notable side effects including anemia, nausea, fatigue, and gastrointestinal issues. Investigational drugs like ONC201 and other emerging therapies may also present unique side effects, but these are generally in line with those seen in more established treatments, including gastrointestinal disturbances and hematologic toxicities.

What prior FDA approvals exist?

Several FDA-approved drugs target cancer cells in the treatment of various tumors. For example, cytarabine and clofarabine are used in the treatment of acute myeloid leukemia, often in combination with other agents like glasdegib and venetoclax. Immune checkpoint inhibitors such as nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) have been approved for treating different types of cancers, including lung cancer and melanoma. Targeted therapies like vemurafenib, a BRAF inhibitor, have shown efficacy in treating tumors with specific genetic mutations. These treatments, similar to the investigational drug ABSK021, aim to inhibit cancer cell growth and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to ABSK021 for tumor patients include: 1) Olaparib (Lynparza) for germline BRCA-mutated metastatic pancreatic cancer, 2) Niraparib plus nivolumab or niraparib plus ipilimumab for platinum-sensitive advanced pancreatic cancer, 3) Nanoparticle albumin-bound paclitaxel in combination with gemcitabine for pancreatic cancer, 4) Immune checkpoint inhibitors such as nivolumab and pembrolizumab for various advanced sarcomas, and 5) Ivosidenib and vorasidenib for IDH-mutant gliomas. These alternatives have shown promising results in clinical trials and may offer effective treatment options in 2024.

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Unknown

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

Be older than 18 years old

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

No Placebo-Only Group

Summary

This trial tests a new pill called ABSK021 in people with serious tumors. It aims to find out if the pill is safe and can help shrink tumors.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment until the date of first documented progression or death, assessed up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and Severity of AEs

Incidence of DLTs

Secondary study objectives

Bioavailability

Cmax

DCR

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for tumors include chemotherapy, targeted therapy, immunotherapy, and radiation. Targeted therapies, like the investigational drug ABSK021, work by interfering with specific molecules that drive cancer growth and progression. These therapies can block the action of enzymes, growth factor receptors, or other proteins involved in tumor cell proliferation and survival. This targeted approach is significant for tumor patients as it can lead to more effective treatments with fewer side effects compared to traditional chemotherapy, ultimately improving patient outcomes and quality of life.