Health TrialsbyHealthPanel

A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )

ConditionSolid Tumors, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd

About this trial

This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients should understand, sign, and date the written informed consent form prior to screening

Male or female age 18 years or older

Patients with histologically confirmed locally-advanced or metastatic solid tumors .

Colorectal cancer (CRC);

Disqualifiers

Known allergy or hypersensitivity to any component of the investigational product

(For backfill cohorts and expansion part) Patients who were previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy

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

Unable to swallow capsules or tablets 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. If any of these conditions exist, the site should discuss with the sponsor to determine patient eligibility

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABSK141-400mg

    Drug

    In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 400mg administration. Thereafter, patients will continuously receive ABSK141 400mg once daily (QD).

  • ABSK141-Recommended Dose for Expansion (RDE)

    Drug

    In the expansion part# patients will orally receive ABSK141 at the recommended dose for expansion (RDE).patients will continuously receive ABSK141 Recommended Dose for Expansion (RDE) once daily (QD).

  • ABSK141-800mg

    Drug

    In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 800mg administration. Thereafter, patients will continuously receive ABSK141 800mg once daily (QD).

  • ABSK141-1200mg

    Drug

    In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 1200mg administration. Thereafter, patients will continuously receive ABSK141 1200mg once daily (QD).

  • ABSK141-Recommended Phase 2 dose (RP2D)

    Drug

    Phase II #patients will orally receive ABSK141 at the Recommended Phase 2 Dose (RP2D).

Treatment groups

401 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Escalation part-400mgExperimental treatment 1 intervention
Group B: expansion partExperimental treatment 1 intervention
Group C: Escalation part-800mgExperimental treatment 1 intervention
Group D: Escalation part-1200mgExperimental treatment 1 intervention
Group E: Backfill cohortsExperimental treatment 1 intervention
Group F: Phase IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of DLTs

dose-limiting toxicities

Time frame
from Run-in to Day28
2

Incidence and severity of AEs

Adverse events

Time frame
from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.
3

Incidence and severity of SAEs

serious adverse events

Time frame
from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.

Secondary outcomes

1

Cmax

maximum observed concentration

Time frame
From pre-dose to up to 72 hours post-dose
2

AUC

area under the concentration-time curve

Time frame
From pre-dose to up to 72 hours post-dose
3

t1/2

elimination half-life

Time frame
From pre-dose to up to 72 hours post-dose
4

CL/F

apparent oral clearance

Time frame
From pre-dose to up to 72 hours post-dose

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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