A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

NCT04906434 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ABSK-011-101
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 32

Brief Summary

This is an open-label phase 1 study with an escalation part and an expansion part.

Conditions

Advanced Liver Cancer

Outcome Measures

Primary Outcomes (10)

• Incidence of DLT

  Incidence of dose-limiting toxicities (DLTs) in Cycle 1

  From the starting dosing of study drug to the end of Cycle 1 (each cycle is 28 days) in escalation Part

• Incidence and severity of AEs, AESIs and SAEs

  Incidence and severity of adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs) (Common Terminology Criteria for Adverse Events, CTCAE 5.0)

  30 days after last administration, an average of one half year

• dose reduction or discontinuation

  dose reduction or discontinuation of study drug due to toxicity

  through study completion, an average of one half year

• physical examinations changes from baseline

  BMI

  through study completion, an average of one half year

• ECOG performance status

  ECOG performance status

  through study completion, an average of one half year

• electrocardiograms (ECGs)

  QTc

  through study completion, an average of one half year

• echocardiograms changes from baseline

  EF%

  through study completion, an average of one half year

• vital signs changes from baseline

  Temperature

  through study completion, an average of one half year

• vital signs changes from baseline

  pulse

  through study completion, an average of one half year

• vital signs changes from baseline

  blood pressure

  through study completion, an average of one half year

Secondary Outcomes (14)

• Cmax

  the end of Cycle 1 Day15 (each cycle is 28 days)

• Tmax

  the end of Cycle 1 Day15 (each cycle is 28 days)

• AUC

  the end of Cycle 1 Day15 (each cycle is 28 days)

• t1/2β

  the end of Cycle 1 Day15 (each cycle is 28 days)

• Vz/F

  the end of Cycle 1 Day15 (each cycle is 28 days)

Study Arms (1)

ABSK-011

EXPERIMENTAL

During the escalation part, all patients will first receive a single dose ABSK-011 (run-in period) at Day -2 and be followed by a 1-day off (2 days in all for run-in period) to access the PK of single-dose. Then, patients will continuously receive ABSK-011 once daily (QD) or twice daily (BID) in repeated 28-day cycles. Dose escalation will employ a "3+3" design except for the patient in the accelerated titration cohort. In expansion part, patients will be treated at the selected RDE dose level.

Drug: ABSK-011

Interventions

ABSK-011 DRUG

During the escalation part, the administration of oral ABSK-011 will be guided by "3+3"design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level.

ABSK-011

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 \~ 75 (include both ends, or other age range required by local regulations or IRB).
• Escalation Part: Patients must have histological or cytological confirmed advanced solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists; and patients with advanced HCC must satisfy:
• BCLC stage B or C and Child-Pugh score 5\~6
• Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing
• Expansion Part: patients must have histological or cytological confirmed, BCLC stage B or C HCC, and have progressed on or intolerant to or have refused to receive or have no access to receive first line systemic therapy (by local guideline/regulation) and is unsuitable for other standard therapy(ies) (by local guideline/regulation) against HCC, and must satisfy:
• Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive
• Patient must have at least 1 measurable lesion (RECIST V1.1)
• Child-Pugh score 5\~7 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention
• ECOG performance status 0\~1
• Life expectancy ≥ 3 months
• Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug (without blood transfusion or medication with stimulation factors within 14 days before 1st dose):
• Absolute neutrophil count (ANC) ≥1.5×109/L
• Platelet count (PLT) ≥75×109/L
• Hemoglobin (Hb) ≥80 g/L
• Total bilirubin (TBIL) ≤1.5×ULN

You may not qualify if:

• Known allergy or hypersensitivity to any component of the investigational drug product.
• Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).
• Has a known second primary malignancy required active treatment.
• Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone \<10 mg or other equivalent glucocorticoids can be enrolled).
• Liver tumor volume accounts for ≥50% of the whole liver.
• Inability to take oral medication or other factors significant preclude adequate absorption of oral medication, such as previously received total gastrectomy, residual gastric dysfunction after subtotal gastrectomy, short bowel syndrome after small bowel resection, active diarrhea required drug treatment, etc.
• Severe irritable bowel syndrome requires drug therapy.
• Prior organ transplantation requires anti-rejection drug therapy.
• Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \>30%), routine chemotherapy \<4 weeks (chemotherapy with nitrosourea or mitomycin \<6 weeks); oral chemotherapy, endocrine therapy, molecular targeted therapy or immunotherapy within ≤ 5 half-life or ≤ 4 weeks (whichever is shorter).
• Concomitant use of strong inhibitors or inducers of CYP3A4 (include grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice or products) within at least 14 day prior to the first dose of the study drug.
• Impaired cardiac function or clinically significant cardiac disease, including any one of the following:
• New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within 6 months before administration of the study drug;
• Clinically significant cardiac arrhythmia requiring active therapy;
• Uncontrolled hypertension;
• Left ventricle ejection fraction\<50%

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (32)

Mayo Clinic

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

COMPLETED

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

RECRUITING

The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army

Beijing, Beijing Municipality, China

WITHDRAWN

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

COMPLETED

Sun Yat Sen Memorial Hospital

Guangzhou, Guangdong, China

COMPLETED

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, China

COMPLETED

Weifang People's Hospital

Weifang, Hebei, China

COMPLETED

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

RECRUITING

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

COMPLETED

Henan Cancer Hospital

Zhengzhou, Henan, China

COMPLETED

Hubei Cancer Hospital

Wuhan, Hubei, China

COMPLETED

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

COMPLETED

Hunan Provincial People's Hospital

Changsha, Hunan, China

WITHDRAWN

Suzhou University Affiliated Second Hospital

Suzhou, Jiangsu, China

COMPLETED

Tonghua Central Hospital

Tonghua, Jilin, China

COMPLETED

Shengjing Hospital of China medical university

Shenyang, Liaoning, China

COMPLETED

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

COMPLETED

Jinan Central Hospital

Jinan, Shandong, China

COMPLETED

Linyi Cancer Hospital

Linyi, Shandong, China

COMPLETED

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

WITHDRAWN

Mianyang Central Hospital

Mianyang, Sichuan, China

RECRUITING

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

WITHDRAWN

National Cheng Kung University Hospitals

Tainan, Taiwan

COMPLETED

Nation Taiwan University Hospital

Taipei, Taiwan

COMPLETED

Study Officials

• Xiaoping Chen, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Lu, Doctor

CONTACT

+86021-68910052; clinical@abbisko.cn

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: April 21, 2021
• First Posted: May 28, 2021
• Study Start: February 26, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (6); CN (24); TW (2)