Actively Recruiting
An Open-label Phase 2 Study of ABSK061 and ABSK043 With or Without Chemotherapy in Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations
Led by Abbisko Therapeutics Co, Ltd · Updated on 2024-11-19
202
Participants Needed
21
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the anti-tumor effects of two drugs, ABSK061 and ABSK043, in patients with metastatic or unresectable solid tumors that have specific FGFR2 or FGFR3 gene changes. This Phase 2 study focuses on tumors driven by FGFR alterations regardless of the tumor type. The study includes a screening phase, a treatment phase, and a follow-up period lasting until the participant dies, withdraws consent, is lost to follow-up, or the study ends, whichever comes first. Participants receive oral capsules of ABSK061 and ABSK043. Some patients with HER2-negative gastric or gastroesophageal junction cancer with FGFR2 changes will also receive chemotherapy called CAPOX along with the study drugs. Treatment continues until the disease worsens, unacceptable side effects occur, consent is withdrawn, or the investigator decides to stop treatment. The study follows patients for up to five years to monitor effects. During the study, participants undergo evaluations including tumor assessments by RECIST criteria, safety monitoring for dose-limiting toxicities, and pharmacokinetic tests measuring drug levels over time. Researchers will track outcomes such as overall response rate, progression-free survival, duration of response, disease control rate, and overall survival. Follow-up continues after treatment ends to collect long-term data and ensure patient safety throughout the study duration.
CONDITIONS
Brief 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 per RECIST v1.1 (except expansion cohort 1)
- Histologically confirmed solid tumors with progression after standard care or no available standard therapy
- Central lab or prior test confirming FGFR2/3 activating alterations or overexpression in tumor tissue or blood
- For Cohort 1: HER2-negative metastatic/unresectable gastric/gastroesophageal cancer with FGFR2 amplification or overexpression
- Prior tumor tissue available or willingness to undergo biopsy if needed
- No more than one prior systemic chemotherapy for advanced gastric/gastroesophageal cancer or progression >6 months after adjuvant therapy
- For Cohort 2: Metastatic/unresectable urothelial carcinoma with specific FGFR3 mutation, fusion, or overexpression
- No more than one prior systemic chemotherapy for advanced urothelial carcinoma or progression >12 months after adjuvant therapy, or progression/toxicity after standard care
- For Cohort 3: Metastatic/unresectable non-small cell lung cancer with FGFR2/3 alterations
- Progression or toxicity after at least one prior standard or targeted therapy
- For Cohort 4: Metastatic/unresectable other solid tumors with FGFR2/3 alterations
- Progression or toxicity after at least one prior standard therapy
You will not qualify if you...
- Previous treatment with FGFR pathway or multi-kinase inhibitors targeting FGFR
- Active or history of autoimmune diseases such as myasthenia gravis, lupus, rheumatoid arthritis, multiple sclerosis, and others (type 1 diabetes and controlled hypothyroidism allowed)
- Clinically symptomatic lung disease requiring corticosteroids within 6 months prior to enrollment
- Other progressing malignancies needing active treatment (except certain cured skin or prostate cancers)
- Recent major surgery, radiotherapy, immunotherapy, chemotherapy, endocrine or targeted therapy within specified time frames before study start
- Not recovered to Grade 1 or better from prior treatment toxicities except permitted conditions
- History of Grade 3 or higher immune-related adverse events
- For Cohort 3: Presence of driver mutations (EGFR, ALK, KRAS, NTRK, RET, MET, BRAF, ROS1) without targeted therapy received prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision
Participants receive oral doses of ABSK061 and ABSK043, with or without chemotherapy, until disease progression, intolerable toxicity, withdrawal of consent, investigator decision, or end of data collection if clinical benefit is observed.
Visits every 21 or 28 days per treatment cycle
Duration - Up to 5 years
Participants are followed after treatment ends until death, withdrawal of consent, loss to follow-up, or end of study.
Follow-up visits as scheduled up to 5 years
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
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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