Actively Recruiting
A Phase 2 Clinical Study of ABSK061 and ABSK043
Led by Abbisko Therapeutics Co, Ltd · Updated on 2024-11-19
202
Participants Needed
21
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations
CONDITIONS
Official Title
A Phase 2 Clinical Study of ABSK061 and ABSK043
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have measurable target lesions (RECIST v1.1) except expansion cohort 1
- Patients with histologically confirmed solid tumors progressed after standard care, intolerant to standard therapy, or no standard care available
- Confirmed FGFR2/3 gene activating alterations or overexpression by central or previous lab tests
- Cohort 1: HER2-negative metastatic/unresectable gastric/gastroesophageal junction cancer with FGFR2 amplification or overexpression
- Willingness to provide prior tumor tissue or undergo biopsy if needed
- No prior or up to one course of chemotherapy for advanced gastric/gastroesophageal junction cancer, or progression more than 6 months after last adjuvant therapy
- Cohort 2: Metastatic/unresectable urothelial carcinoma with confirmed FGFR3 mutation or overexpression
- No prior or up to one course of chemotherapy for advanced urothelial carcinoma, or progression more than 12 months after last adjuvant therapy, or progression/intolerable toxicity after at least one standard care line
- Cohort 3: Metastatic/unresectable non-small cell lung cancer with confirmed FGFR2/3 mutation, fusion, or overexpression
- Progression or intolerable toxicity after at least one prior standard care or targeted therapy line
- Cohort 4: Metastatic/unresectable other solid tumors with confirmed FGFR2/3 activating alterations or overexpression
- Progression or intolerable toxicity after at least one prior standard therapy
You will not qualify if you...
- Prior treatment with FGFR pathway inhibitors or multi-kinase inhibitors targeting FGFR
- Active or history of autoimmune diseases excluding some conditions like type 1 diabetes or hypothyroidism
- Symptomatic lung disease requiring systemic corticosteroids within 6 months
- Other progressive or actively treated malignancies except specific cured or low-risk cancers
- Recent major surgery, radiotherapy, immunotherapy, or chemotherapy within specified timeframes before study
- Unrecovered toxicities from prior cancer therapies above Grade 1 (with some exceptions)
- History of Grade 3 or higher immune-related adverse events
- For NSCLC cohort: presence of certain driver mutations without prior targeted therapy as per guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Guizhou Provincial People'S Hospital
Guiyang, Guizhou, China, 550000
Not Yet Recruiting
2
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000
Not Yet Recruiting
3
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Heibei, China, 050000
Not Yet Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
6
Hunan Central Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
7
Jiangxi Cance Hospital
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
8
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
9
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250000
Not Yet Recruiting
10
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
11
Xiangyang Central Hospital
Xiangyang, Sichuang, China, 610000
Not Yet Recruiting
12
Changzhi People's Hospital
Changzhi, China
Not Yet Recruiting
13
West China Hospital, Sichuan University
Chengdu, China
Not Yet Recruiting
14
The First Hospital of China Medical University
Hangzhou, China
Not Yet Recruiting
15
Zhejiang Provincial People'S Hospital
Hangzhou, China
Not Yet Recruiting
16
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Not Yet Recruiting
17
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China
Not Yet Recruiting
18
First Hospital of Shanxi Medical University
Xi'an, China
Not Yet Recruiting
19
Shanxi Cancer hospital (Shanxi Cancer institute)
Xi'an, China
Not Yet Recruiting
20
First Affiliated Hospital of Xiamen University
Xiamen, China
Not Yet Recruiting
21
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Not Yet Recruiting
Research Team
Y
Yuan Lu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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