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ABSK061 for Solid Tumors

Phase 1

Recruiting

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

Male or female age 18 years or older

Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥ 100×109/L without transfusion requirement within 14 days before 1st dose, Hemoglobin (Hb)≥90 g/L, Total bilirubin (TBIL) ≤1×ULN, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN, Serum creatinine (Cr) of ≤1.5×ULN for the reference laboratory or creatinine clearance (Crcl) ≥ 50 mL/min based on Cockcroft-Gault formula

Must not have

Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication

Has a known additional malignancy that is progressing or has required active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the study completion, an average of half year

Awards & highlights

No Placebo-Only Group

Summary

This trialtests a new drug to treat advanced solid tumors, looking at safety, tolerability, and effectiveness.

Who is the study for?

This trial is for adults with advanced solid tumors, specifically urothelial carcinoma or cholangiocarcinoma that's worsened despite treatment or when no standard treatment exists. Participants must have measurable lesions, a life expectancy of at least 3 months, and certain genetic alterations in their tumors. They need good organ function and can't be part of the trial if they've had recent major surgery, untreated brain metastases, active hepatitis or HIV infections, heart problems, eye diseases affecting the retina or cornea, uncontrolled fluid accumulation in the body cavities, are pregnant/nursing or unwilling to use effective contraception.

What is being tested?

The study tests ABSK061 given orally over repeated 28-day cycles to see how safe it is and how well patients tolerate it. It starts with dose escalation to find an appropriate dose level followed by expansion at this recommended dose among selected tumor types while also checking preliminary effects on tumor size.

What are the potential side effects?

While specific side effects aren't listed here as this is a Phase I trial primarily assessing safety and tolerability of ABSK061 in humans for the first time; potential side effects could include typical reactions such as nausea, fatigue, allergic responses to medication components and possibly others depending on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My blood tests meet the required levels for the study.

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I am fully active or can carry out light work.

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My cancer has worsened or I can't tolerate standard treatments, and no other options are available.

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I have urothelial carcinoma or cholangiocarcinoma and standard treatments haven’t worked or aren’t suitable for me.

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My tumor has specific FGFR2/3 genetic changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take pills due to severe nausea, vomiting, or issues with my digestive system.

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I have another cancer that is getting worse or needs treatment.

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I have uncontrolled fluid buildup in my abdomen or around my lungs.

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I have not had major surgery in the last 4 weeks and my surgical wounds are healed.

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I have a history of significant eye problems or treatments.

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I haven't had cancer treatment, including chemo or targeted therapy, in the last 4 weeks.

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I have brain metastases that are causing symptoms or need steroids.

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I have not received any live vaccines within the last 4 weeks.

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I have serious heart problems or uncontrolled high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of half year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of half year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of half year 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 adverse events (AEs)

Incidence of DLT

Secondary study objectives

AUC

AUCss

CL/F

+11 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: ABSK061Experimental Treatment1 Intervention

Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed.

0 / 15Eligibility criteria met