Health TrialsbyHealthPanel

A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors

ConditionSolid Tumors (Phase 1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd

About this trial

This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patients should understand, sign, and date the written informed consent form before screening.

2. Male or female aged 18 years or older.

3. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type.

4. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing.

Disqualifiers

1. Known allergy or hypersensitivity to any component of ABSK131.

2. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.

3. Another active primary malignancy.

4. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABSK131

    Drug

    In the escalation part，patients will first orally receive a single dose of ABSK131 on D-2, followed by a two-day run-in period to assess the PK profile of single-dose ABSK131 administration. Thereafter, patients will continuously receive ABSK131 once daily (QD). In the expansion part， patients will orally receive ABSK131 at the recommended dose for expansion (RDE)

Treatment groups

266 Participants
are divided into 1 treatment group
Group A: Escalation and expansion partExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of DLT

Dose-limiting toxicities

Time frame
from Run-in to Day21
2

AEs

Adverse events

Time frame
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
3

AESIs

Adverse events of special interest (AESIs)

Time frame
he date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
4

SAEs

Serious adverse events (SAEs)

Time frame
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months

Secondary outcomes

1

Cmax

Maximum observed concentration

Time frame
From date of enrollment（Run-） until the date of end of treatment visit, assessed up to 30 months
2

AUC

area under the concentration-time curve

Time frame
From date of enrollment（R） until the date of end of treatment visit, assessed up to 30 months
3

t1/2

elimination half-life

Time frame
From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months
4

CL/F

apparent oral clearance

Time frame
From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbisko Therapeutics Co, Ltd

Lead sponsor

Source ClinicalTrials.gov
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