Actively Recruiting
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
Led by Abbisko Therapeutics Co, Ltd · Updated on 2024-08-12
85
Participants Needed
22
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
CONDITIONS
Official Title
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign informed consent before screening.
- Male or female patients aged 18 years or older.
- For dose escalation: patients with histologically confirmed advanced solid tumors progressed after or intolerant to standard therapy or with no standard therapy available.
- For expansion: patients with urothelial carcinoma or cholangiocarcinoma progressed after or intolerant to standard therapy.
- Tumors must have FGFR2/3 genetic alterations confirmed by central lab or existing reports for expansion patients.
- At least one measurable target lesion per RECIST 1.1.
- Willingness to undergo biopsy if archival tumor tissue is unavailable or inadequate.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate organ and bone marrow function confirmed within 14 days prior to first dose, including ANC ≥1.5x10^9/L, platelet count ≥100x10^9/L, hemoglobin ≥90 g/L, total bilirubin ≤1xULN, AST and ALT ≤2.5xULN, serum creatinine ≤1.5xULN or creatinine clearance ≥50 mL/min.
You will not qualify if you...
- Known allergy or hypersensitivity to any component of the investigational drug.
- For expansion: previous treatment with FGFR pathway inhibitors or multi-kinase inhibitors targeting FGFR.
- Presence of another progressing malignancy requiring active treatment.
- Inability to take oral medication or significant gastrointestinal issues affecting absorption.
- Anti-cancer therapy, including chemotherapy (nitrosourea or mitomycin at least 6 weeks prior), radiotherapy, targeted therapy, or investigational drugs within 4 weeks; endocrine therapy within 2 weeks or 5 half-lives before starting study drug.
- Major surgery within 4 weeks before first dose; surgical wounds must be healed and infection-free.
- Prior toxicities from treatments not resolved to Grade 1 severity except alopecia and vitiligo.
- Use of drugs or remedies causing pharmacokinetic interactions, or consumption of grapefruit, pomegranates, starfruit, pomelos, Seville oranges or juices within 7 days before first dose.
- Active central nervous system metastases or related symptoms.
- Significant cardiac disease or impaired cardiac function including specific heart conditions, QT prolongation, or low ejection fraction.
- Known HIV or active hepatitis B or C infections except controlled cases.
- Certain eye conditions including retinal, macular, corneal diseases or prior related treatments.
- Uncontrolled ascites or pleural effusion.
- Pregnant or nursing women; required birth control for patients of childbearing potential.
- Recent vaccination with live attenuated vaccines within 4 weeks before or during the trial.
- Other significant comorbidities that could affect protocol compliance or safety as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
2
Yuan LU
Shanghai, Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, China, 201203
Actively Recruiting
3
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Actively Recruiting
4
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Not Yet Recruiting
5
Chongqing Daping Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
6
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
7
Zhejiang Cancer Hospital
Hangzhou, Gongshu District, China
Actively Recruiting
8
Sun Yat-sen Memorial Hospital/ the Second Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, China
Actively Recruiting
9
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
10
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
11
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
12
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
13
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Not Yet Recruiting
14
Xuzhou Center Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
15
First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
16
JILIN Cancer Hospital
Changchun, Jilin, China
Not Yet Recruiting
17
Yunnan Cancer Hospital
Yunnan, Kunming, China
Not Yet Recruiting
18
Liaoning Province Cancer Hospital
Shenyang, Liaoning, China
Actively Recruiting
19
The First Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
20
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
21
Chongqing University Cancer Hospital
Chongqing, Sichuan, China
Actively Recruiting
22
The Second Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yuan LU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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