Trial Title:
A Phase 2 Clinical Study of ABSK061 and ABSK043
NCT ID:
NCT06632262
Condition:
HER2-Gastric/Gastroesophageal Junction Cancer
Urothelial Carcinoma
Non-Small Cell Lung Cancer
Solid Tumors
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Transitional Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABSK061 + ABSK043
Description:
Participants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene
fusions will receive a dose of ABSK061 + ABSK043 oral capsule until disease progression,
intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue
treatment, or end of data collection timepoint if there is clinical benefit in the
opinion of the investigator, has been achieved.
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4
Intervention type:
Drug
Intervention name:
ABSK061+ABSK043 in combination with CAPOX
Description:
Participants with HER2-Gastric/Gastroesophageal Junction Cancer and fibroblast growth
factor receptor 2( FGFR2 ) amplification and overexpression will receive a dose of
ABSK061 + ABSK043 oral capsule in combination with CAPOX until disease progression,
intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue
treatment, or end of data collection timepoint if there is clinical benefit in the
opinion of the investigator, has been achieved.
Arm group label:
Cohort 1
Summary:
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
Detailed description:
ABSK061 is a selective and potent pan FGFR 2/3 inhibitor with demonstrated clinical
activity in participants with a variety of FGFR inhibitors in a variety of solid tumors.
ABSK043 is a small molecule PD-L1 inhibitor with good oral bioavailability, high
selectivity and high activity, and is currently being developed for the treatment of
multiple cancers and potential non-oncology indications.
This study targets the underlying altered biology of FGFR-driven tumors irrespective of
solid tumor histology subtype. The study consists of screening phase, treatment phase and
the post treatment follow-up phase (from the end of treatment visit until the participant
has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes
first). End of study is considered of the last visit of the last patient in this trial or
the procedures shown in the schedule, or 12 months after the first dose of the last
enrolled patient, whichever occurs first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have a measurable target lesion (per RECIST v1.1) (not applicable to
expansion cohort 1) where:
- Dose Escalation: patients with histologically confirmed solid tumors who have
progressed after standard of care, are unable to tolerate standard therapy, or have
no standard of care currently available:
- Patients must have the a central laboratory or previous test report confirming
FGFR2/3 gene activatingon alterations (including FGFR2/3 activating mutations,
fusions/rearrangements, or FGFR2 amplifications) or overexpression in tumor tissue
or blood based on central laboratory test or previous test reports.
- Expansion Phase:
- Cohort 1 (HER2-gastric/gastroesophageal junction cancer)
- Histologically or cytologically confirmed metastatic/unresectable
gastric/gastroesophageal junction cancer, HER2 test negative
- The patient had FGFR2 amplification or overexpression in tumor tissue confirmed by a
central laboratory test or a previous test report (previous test report only applied
to FGFR2 amplification)
- Patients need to provide prior tumor tissue or willingness to undergo biopsy if no
prior tumor tissue or insufficient quantity is required
- No prior (or up to one course of chemotherapy) systemic therapy for advanced
gastric/gastroesophageal junction cancer, or disease progression more than 6 months
after the end of the last prior adjuvant therapy
- Patients must have a measurable target lesion or evaluable non-target lesion (per
RECIST v1.1)
- Cohort 2 (urothelial carcinoma)
- Histologically or cytologically confirmed metastatic/unresectable urothelial
carcinoma with other histologic differentiation (including adenoid, squamous, or
other types)
- Patients must have the prespecified a central laboratory or previous test report
confirming the presence of a specific FGFR3 mutation or overexpression, FGFR2/3
fusion in tumor tissue or blood based on central laboratory test or previous test
reports.
- No prior (or up to one course of chemotherapy) systemic therapy for advanced
urothelial carcinoma, or disease progression more than 12 months after the end of
the last prior adjuvant therapy, or disease progression or intolerable toxicity
after at least one line of standard of care (per local standard of care or
guidelines)
- Cohort 3 (non-small cell lung cancer)
- Histologically or cytologically confirmed metastatic/unresectable non-small cell
lung cancer (NSCLC)
- Patients must have the prespecified a central laboratory or previous test report
confirming the presence of a specific FGFR2/3 mutation, fusion, or overexpression in
tumor tissue or blood based on central laboratory test or previous test reports.
- Disease progression or intolerable toxicity after at least one prior line of
standard of care or targeted therapy for driver mutations (according to local
standards of care or guidelines)
- Cohort 4 (Other Solid Tumors)
- Histologically or cytologically confirmed metastatic/unresectable other solid tumors
- Patients must have a central laboratory or previous test report confirmingthe
FGFR2/3 gene activationng alterations (including FGFR2/3 activating mutations,
fusions/rearrangements, or FGFR2 amplifications) or overexpression in tumor tissue
or blood based on central laboratory test or previous test reports.
- Disease progression or intolerable toxicity after at least one prior line of
standard therapy.
Exclusion Criteria:
- Previous treatment with an FGFR pathway inhibitor or a multi-kinase inhibitor
designed to inhibit FGFR (consultation with the sponsor is recommended)
- Active or medical history of autoimmune diseases, including but not limited to
myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,
rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated
with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome,
Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
(Patients with type 1 diabetes mellitus, hypothyroidism requiring hormone
replacement therapy only, skin diseases that do not require systemic treatment
(e.g., vitiligo, psoriasis, or alopecia) are allowed.Uncertain autoimmune-related
status should be discussed with the sponsor).
- The patient had clinically symptomatic lung disease (e.g. interstitial pneumonia,
pulmonary fibrosis, severe radiation pneumonitis, etc.) requiring systemic
corticosteroid therapy within 6 months prior to enrollment.
- Known other malignancies that are in progression or require active treatment (except
cured skin cancer, carcinoma in situ of the cervix, basal cell carcinoma, focal
prostate cancer with a Gleason score of 6, focal prostate cancer with a Gleason
score of 3 + 4 and treated for more than 6 months at screening).
- Time from the end of other prior anti-tumor therapy to the first dose of study drug:
major surgery (palliative treatment for local lesions is allowed), in vitro and in
vivo radiotherapy (> 30% bone marrow exposure) is less than 4 weeks; received
immunotherapy or other antibody study drugs within 4 weeks prior to the start of
study treatment; received chemotherapy (within 6 weeks of the start of study
treatment with nitrosourea or mitomycin chemotherapy), endocrine therapy, and small
molecule targeted therapy within 2 weeks or 5 half-lives, whichever is shorter.
- Patients who have not recovered to ≤ Grade 1 (CTCAE v5.0) from toxicities caused by
prior chemotherapy, radiotherapy, and other anti-tumor therapies, including
immunotherapy (except for alopecia as permitted by eligibility criteria or alopecia,
vitiligo, stable hypothyroidism controlled by hormone replacement therapy, ≤ Grade 2
hearing loss, or ≤ Grade 2 peripheral neurotoxicity).
- History of ≥ Grade 3 immune-related adverse events with prior therapy.
- (Expansion Cohort 3 (non-small cell lung cancer)) Patients were previously
identified with driver mutations (according to local diagnostic and therapeutic
criteria or guidelines such as EGFR mutation, ALK rearrangement positive, KRAS G12C
mutation positive, NTRK1/2/3 gene fusion positive, RET fusion positive, MET exon 14
skipping mutation, BRAF V600E mutation positive, ROS1 rearrangement positive) and
did not receive targeted therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guizhou Provincial People'S Hospital
Address:
City:
Guiyang
Zip:
550000
Country:
China
Contact:
Last name:
Jie Luo
Phone:
86851-85607982
Email:
1654377211@qq.com
Investigator:
Last name:
Shisheng Tan, Doctor
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hospital of Guizhou Medical University
Address:
City:
GuiYang
Zip:
550000
Country:
China
Contact:
Last name:
Peng Du
Phone:
+86(851)86752817
Email:
19044055@qq.com
Investigator:
Last name:
Jing Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Contact:
Last name:
Mingxia Wang
Phone:
0311-66696233
Email:
office_hb4th@126.com
Investigator:
Last name:
Qun Zhao, Doctor
Email:
Principal Investigator
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Contact:
Last name:
Jinlu Wang
Phone:
0451-86298192
Email:
sylcyj609@163.com
Investigator:
Last name:
Yanqiao Zhang, Doctor
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Baoxia He
Phone:
0371-65587610
Email:
hnszlyylixiang@163.com
Investigator:
Last name:
Jufeng Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
Hunan Central Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Contact:
Last name:
Yun Jiang
Phone:
0731-88651669
Email:
hnszlyy_gcp@163.com
Investigator:
Last name:
Zhenyang Liu, Doctor
Email:
Principal Investigator
Facility:
Name:
Jiangxi Cance Hospital
Address:
City:
Nanchang
Zip:
330000
Country:
China
Contact:
Last name:
Yuan Gao
Phone:
0791-88331395
Email:
jxzljgb@126.com
Investigator:
Last name:
Bo Yi, Doctor
Email:
Principal Investigator
Facility:
Name:
Liaoning Cancer Hospital and Institute
Address:
City:
Shenyang
Zip:
110000
Country:
China
Contact:
Last name:
Yi Wang
Phone:
024-81916651
Email:
564066425@qq.com
Investigator:
Last name:
Yan Zhao, Doctor
Email:
Principal Investigator
Facility:
Name:
Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250000
Country:
China
Contact:
Last name:
Yuanyuan Lv
Phone:
0531-67626063
Email:
ywb234@126.com
Investigator:
Last name:
Yan Zhang, Doctor
Email:
Principal Investigator
Investigator:
Last name:
Zuoxing Niu, Doctor
Email:
Principal Investigator
Facility:
Name:
ZhongShan Hospital Fudan University
Address:
City:
Shanghai
Zip:
200000
Country:
China
Contact:
Last name:
YiJu Gao
Phone:
8621-31587861
Email:
lcsyjg@zs-hospital.sh.cn
Investigator:
Last name:
Tianshu Liu, Doctor
Email:
Principal Investigator
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xiangyang
Zip:
610000
Country:
China
Contact:
Last name:
Xiaomu Wang
Phone:
0710-2811523
Email:
xyszxyygcp@163.com
Investigator:
Last name:
Tienan Yi, Doctor
Email:
Principal Investigator
Facility:
Name:
Changzhi People's Hospital
Address:
City:
Changzhi
Country:
China
Contact:
Last name:
Na Si
Phone:
+8615235503549
Email:
wana86211306@126.com
Investigator:
Last name:
Jun Zhao, Doctor
Email:
Principal Investigator
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Contact:
Last name:
Ying Qian
Phone:
028-85422707
Email:
huaxigcp@163.com
Investigator:
Last name:
Guowei Che, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Hangzhou
Country:
China
Contact:
Last name:
Yuqing Zhang
Phone:
+8615140139773
Email:
cmu_lawyer@163.com
Investigator:
Last name:
Funan Liu, Doctor
Email:
Principal Investigator
Facility:
Name:
Zhejiang Provincial People'S Hospital
Address:
City:
Hangzhou
Country:
China
Contact:
Last name:
Ying Wang
Phone:
0571-85893646
Email:
nancywangying@163.com
Investigator:
Last name:
Yiping Mu, Doctor
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Yu Zheng
Phone:
+8613820049201
Email:
gcpcenter@tjmuch.com
Investigator:
Last name:
Hongli Li, Doctor
Email:
Principal Investigator
Facility:
Name:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Address:
City:
Wuhan
Country:
China
Contact:
Last name:
Chang Shu
Phone:
027-83663940
Email:
tongjigcp@163.com
Investigator:
Last name:
Xianglin Yuan, Doctor
Email:
Principal Investigator
Facility:
Name:
First Hospital of Shanxi Medical University
Address:
City:
Xi'an
Country:
China
Contact:
Last name:
Yilai Song
Phone:
0351-4639072
Email:
lzgwyy@sina.com
Investigator:
Last name:
Yusheng Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
Shanxi Cancer hospital (Shanxi Cancer institute)
Address:
City:
Xi'an
Country:
China
Contact:
Last name:
Guozhong Wang
Phone:
0351-4651590
Email:
15234165176@163.com
Investigator:
Last name:
Wenhui Yang, Doctor
Email:
Principal Investigator
Facility:
Name:
First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Contact:
Last name:
Mingxia Fan
Phone:
0592-2137232
Email:
xdfygcp@sina.com
Investigator:
Last name:
Feng Ye, Doctor
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Country:
China
Contact:
Last name:
Haijing Jiang
Phone:
0516-85802369
Email:
xyfy2369@163.com
Investigator:
Last name:
Jun Song, Doctor
Email:
Principal Investigator
Start date:
November 30, 2024
Completion date:
June 30, 2030
Lead sponsor:
Agency:
Abbisko Therapeutics Co, Ltd
Agency class:
Industry
Source:
Abbisko Therapeutics Co, Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06632262
