NCT07417189

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for phase_1

Timeline
40mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Jul 2029

First Submitted

Initial submission to the registry

January 28, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2029

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

January 28, 2026

Last Update Submit

March 9, 2026

Conditions

Solid Tumors, Adult

Keywords

ABSK141KRAS G12D

Outcome Measures

Primary Outcomes (3)

  • Incidence of DLTs

    dose-limiting toxicities

    from Run-in to Day28

  • Incidence and severity of AEs

    Adverse events

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

  • Incidence and severity of SAEs

    serious adverse events

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

Secondary Outcomes (10)

  • Cmax

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

  • AUC

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

  • t1/2

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

  • CL/F

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

  • tmax

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

  • +5 more secondary outcomes

Study Arms (6)

Escalation part-400mg

EXPERIMENTAL

ABSK141 (investigational drug) tablet, 400 mg administered orally once daily (QD), continuously until disease progression.

Drug: ABSK141-400mg

expansion part

EXPERIMENTAL

ABSK141 (investigational drug) tablet,Recommended Dose for Expansion (RDE) administered orally once daily (QD), continuously until disease progression.

Drug: ABSK141-Recommended Dose for Expansion (RDE)

Escalation part-800mg

EXPERIMENTAL

ABSK141 (investigational drug) tablet, 800 mg administered orally once daily (QD), continuously until disease progression.

Drug: ABSK141-800mg

Escalation part-1200mg

EXPERIMENTAL

ABSK141 (investigational drug) tablet, 1200 mg administered orally once daily (QD), continuously until disease progression.

Drug: ABSK141-1200mg

Backfill cohorts

EXPERIMENTAL

ABSK141 (investigational drug) tablet, The decision-making on doses for backfill cohorts will be based on the discussion and alignment between the Sponsor and Investigator.

Drug: ABSK141-Recommended Dose for Expansion (RDE)

Phase II

EXPERIMENTAL

ABSK141 (investigational drug) tablet, administered at the Recommended Phase 2 Dose (RP2D) continuously until disease progression.

Drug: ABSK141-Recommended Phase 2 dose (RP2D)

Interventions

ABSK141-400mgDRUG

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).

Also known as: ABSK141, investigational drug
Escalation part-400mg
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).

Also known as: ABSK141, investigational drug
Backfill cohortsexpansion part
ABSK141-800mgDRUG

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).

Also known as: ABSK141, investigational drug
Escalation part-800mg
ABSK141-1200mgDRUG

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).

Also known as: ABSK141, investigational drug
Escalation part-1200mg
ABSK141-Recommended Phase 2 dose (RP2D)DRUG

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

Also known as: ABSK141, investigational drug
Phase II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .
  • For backfill cohorts in the escalation part:
  • Patients must have the following solid tumor harboring KRAS G12D mutation:
  • Colorectal cancer (CRC);
  • Non-small cell lung cancer (NSCLC);
  • Pancreatic ductal adenocarcinoma (PDAC);
  • Patients must have at least one measurable target lesion according to RECIST 1.1
  • For expansion Part:
  • Patients must have the following solid tumor harboring KRAS G12D mutation:
  • Colorectal cancer (CRC);
  • Non-small cell lung cancer (NSCLC);
  • Pancreatic ductal adenocarcinoma (PDAC);
  • Other solid tumors;
  • +10 more criteria

You may not qualify if:

  • 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
  • Previous anti-tumor therapy, including chemotherapy, endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life (whichever is shorter), radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment
  • Major surgery within 4 weeks of the first dose of study drug. Note that all surgical wounds must be healed and free of infection or dehiscence
  • Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy, that have not regressed to Grade ≤1 severity (CTCAE v5.0)
  • Patients should not use proton pump inhibitors for at least 7 days prior to the first dose of ABSK141 and during treatment with ABSK141.
  • P-gp inhibitor and strong CYP3A inhibitors to 7 days or 5 half-lives whichever is longer and for CYP3A inducers to 2 weeks or 5 half-lives
  • Active central nervous system (CNS) metastases
  • History of interstitial lung disease requiring systemic steroid treatment.
  • Impaired cardiac function or clinically significant cardiac disease
  • NSCLC cohorts: Patient previously identified as having a driver mutation (according to local standard of care or guidelines) and have not received any targeted therapy, for example: EGFR mutation, ALK rearrangement, KRAS G12C mutation, NTRK1/2/3 gene fusion, RET fusion, MET exon14 skipping mutation, BRAF V600E mutation, ROS1 rearrangement, etc
  • Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody
  • Patients with refractory/uncontrolled ascites or pleural effusion
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 201321, China

RECRUITING

MeSH Terms

Interventions

Drugs, Investigational

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Xianjun Yu, Doctor

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zhang, Bachelor

CONTACT

+86-021-68912098yuco.zhang@abbisko.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 18, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

July 30, 2029

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)