ABSK121-NX 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

Be older than 18 years old

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 trial tests a new drug called ABSK121-NX for patients with advanced solid tumors. It aims to find the safest dose and see if the drug can help reduce or control the tumors.

Who is the study for?

This trial is for adults with advanced solid tumors that have specific genetic changes in FGFR genes. Participants must be over 18, have a life expectancy of at least 3 months, measurable cancer according to certain criteria, and good organ and bone marrow function. They can't join if they've had recent cancer treatments or surgeries, are unable to swallow pills, or have other active cancers.

What is being tested?

ABSK121-NX is being tested in this study. It starts with dose escalation to find the safest dose that patients tolerate well and then expands to more patients at this dose. The drug is taken orally in repeated cycles every 28 days to check its safety and how it affects different types of tumors.

What are the potential side effects?

While the side effects for ABSK121-NX aren't listed here specifically, common side effects from drugs targeting FGFR alterations may include dry mouth, increased thirst, low phosphate levels in blood (hypophosphatemia), nail changes, hair loss or skin reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the 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

AUCtau,ss

+12 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: ABSK121-NXExperimental Treatment1 Intervention

Dose escalation of oral ABSK121-NX 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. Patients will receive a single dose of ABSK121-NX on Day -7 followed by a 7-day washout, as a run-in period to access the safety and PK of ABSK121-NX. Then, patients will continuously receive ABSK121-NX once daily (QD). The dose escalation will start at 3 mg QD followed by dose escalation of a total of 8 potential dose levels. Once RDE is determined, an RDE-confirmation group of up to 24 more patients may be enrolled at the selected dose levels to further evaluate safety and efficacy (up to 12 per dose level/regimen), if approved by the sponsor. In addition, a preliminary food-effect (FE) may be evaluated in at least 6 patients from the RDE- confirmation part. After the RDE is confirmed in the dose Escalation part, the dose Expansion phase will be conducted.

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