A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration

NCT07718165 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ABSK211-101
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.

Conditions

Solid Tumor (Phase I)

Keywords

ABSK211, KRAS Alteration

Outcome Measures

Primary Outcomes (3)

• Incidence of DLTs

  dose-limiting toxicities

  from Run-in to Day21

• AEs

  Adverse events

  The date of signing the informed consent form until 30 days (including Day 30) after the last administration of investigational product

• SAEs

  Serious adverse events (SAEs)

  The date of signing the informed consent form until 30 days (including Day 30) after the last administration of investigational product

Secondary Outcomes (13)

• Cmax

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

• Tmax

  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

Study Arms (1)

ABSK211

EXPERIMENTAL

During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days； In the expansion part，participants will orally receive ABSK211 at the recommended dose for expansion (RDE).

Drug: ABSK211

Interventions

ABSK211 DRUG

During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days； In the expansion part，participants will orally receive ABSK211 at the recommended dose for expansion (RDE).

ABSK211

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants should understand, sign, and date the written informed consent form prior to screening.
• Male or female age 18 years or older
• Participants with histologically confirmed locally-advanced or metastatic solid tumors harboring KRAS alteration
• ECOG performance status 0 or 1
• Life expectancy ≥ 3 months
• Adequate organ function and bone marrow function
• For participants participating exploration of food effect:
• )be able to eat a standardized high-fat, high caloric meal within 30 minutes. 2) be able to fast for 10 hours.

You may not qualify if:

• Known allergy or hypersensitivity to any component of the investigational product
• Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS.
• Has a known additional malignancy that is progressing or has required active treatment
• Has swallowing dysfunction or malabsorption syndrome
• Previous anti-tumor therapy, including chemotherapy ,endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life ,radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment.
• Major surgery within 4 weeks of the first dose of investigational product or with any unhealed surgical wounds, infection or dehiscence.
• Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy, that have not regressed to Grade ≤1 severity;
• Participants use proton pump inhibitors for at least 7 days prior to the first dose of ABSK211 and during treatment with ABSK211.
• P-gp inhibitor, moderate and strong CYP3A inhibitors to 7 days or 5 half-lives and for strong CYP3A inducers to 2 weeks or 5 half-lives ;
• Active central nervous system (CNS) metastases;
• History of interstitial lung disease (ILD) requiring systemic steroid treatment;
• Heart disease or medical history ;
• NSCLC cohorts: Participant previously identified as having a driver mutation and have not received any targeted therapy;
• Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody;
• Participants with refractory/uncontrolled ascites or pleural effusion;

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

Location

Study Officials

• Xianjun Yu, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijun Zheng, Master

CONTACT

+86-021-68912098; lijun.zheng@abbisko.com

Jiaojuan He, Master

CONTACT

+86-18930059542; jiaojuan.he@abbisko.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)