20 Participants Needed

ABSK043 for Sarcoma

AR
Overseen ByAlbiruni Razak, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ABSK043, to determine its effectiveness for certain advanced cancers, such as intimal sarcoma or head and neck angiosarcoma. ABSK043 blocks a protein that helps cancer cells evade the immune system, potentially enabling the body to fight back more effectively. The trial aims to assess the drug's safety and efficacy against these cancers. It also seeks specific markers in blood or tumors that might predict who will benefit from the treatment. Eligible participants have advanced cancer that cannot be surgically removed and have not received similar drugs before. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain treatments like systemic steroids or have had recent chemotherapy or radiation. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ABSK043 is likely to be safe for humans?

Research has shown that ABSK043 has a good safety record in earlier studies. Participants tolerated doses up to 1000 mg taken twice a day without experiencing severe side effects that would prevent higher dosing.

The safety profile of ABSK043 is similar to other drugs that aid the immune system in fighting cancer, suggesting that ABSK043 is generally safe. However, as with any treatment, side effects can occur, so discussing any concerns with the study team is important.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for sarcoma, which often include chemotherapy and radiation, ABSK043 acts on the immune system by targeting the PD-L1 protein. This unique mechanism helps the immune system recognize and attack cancer cells more effectively. Researchers are excited about ABSK043 because it offers a new approach to treating sarcoma, potentially with fewer side effects and improved outcomes compared to traditional therapies.

What evidence suggests that ABSK043 might be an effective treatment for sarcoma?

Research has shown that ABSK043, the investigational treatment in this trial, shows promise in fighting cancer by blocking a protein called PD-L1. This protein typically helps cancer cells evade the immune system. By blocking PD-L1, ABSK043 enables the immune system to identify and attack cancer cells. Studies have demonstrated that ABSK043 is effective against tumors, particularly in certain lung cancers. It also enhances the effectiveness of other cancer treatments. Overall, ABSK043 appears safe, with no serious side effects even at high doses.35678

Are You a Good Fit for This Trial?

This trial is for adults over 18 with specific types of sarcoma (angiosarcomas, EHE, intimal sarcoma) who can swallow pills and have measurable disease. They must be relatively healthy (ECOG 0-2), have good organ function, and not be pregnant. It's at the Princess Margaret Cancer Centre.

Inclusion Criteria

My cancer is a type of angiosarcoma located in my head or neck.
I am over 18 years old.
My condition is intimal sarcoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABSK043, an oral PD-L1 inhibitor, to evaluate its safety, tolerability, and efficacy in treating angiogenic sarcomas

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ABSK043
Trial Overview ABSK043 is an experimental oral drug that blocks PD-L1 to potentially help the immune system fight cancer cells. The study aims to assess its benefits, safety, tolerability, and identify biomarkers in patients' tumors or blood.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: open label - Anti-PD-L1 (ABSK043)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

478O Updated results of oral PD-L1 inhibitor ABSK043 in ...ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent, especially in EGFR-mutated lung cancers with high PD-L1 ...
700P First-in-human dose-escalating study of ABSK043, a ...Here, we report the preliminary results from the first-in-human (FIH) study of ABSK043. Methods. The FIH study evaluated the safety, tolerability, PK, PD, and ...
ABSK043 for SarcomaThe main purposes of this study are:* To see if patients with your type of cancer benefit from ABSK043.* To evaluate the safety and tolerability of ABSK043.* To ...
905 Broad anti-tumor activity of a potent and selective ...Results ABSK043 demonstrated strong in vivo synergy with several therapeutic agents such as carboplatin, a key component of the widely used CRC ...
Abbisko will debut two blockbuster clinical research results ...ABSK043 was well tolerated up to 1000 mg BID with no DLT reported and has a safety profile consistent with monoclonal antibody immune checkpoint ...
NCT04964375ABSK043 was well tolerated up to 1000 mg BID with no DLT reported and has a safety profile consistent with monoclonal antibody immune checkpoint inhibitors. On- ...
NCT07164170 | A Phase 2 Clinical Study of Combination ...The escalation part will evaluate the safety, tolerability, preliminary efficacy, and PK profile of different doses of ABSK043 in combination ...
A Phase 2 Clinical Study of ABSK061 and ABSK043The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients ...
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