HER2-Gastric/Gastroesophageal Junction CancerPhase 2NCT06632262
A Phase 2 Clinical Study of ABSK061 and ABSK043
A Phase 2 study testing ABSK061 + ABSK043 and ABSK061+ABSK043 in combination with CAPOX in people with HER2-Gastric/Gastroesophageal Junction Cancer and Urothelial Carcinoma, run by Abbisko Therapeutics Co, Ltd at 21 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma, Non-Small Cell Lung Cancer
- What is being tested?
- ABSK061 + ABSK043 and ABSK061+ABSK043 in combination with CAPOX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 21 sitesChina
- Study dates
- 13 Nov 2024to 30 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites, 21 recruiting
- Not yet recruiting
Hunan Central Hospital
Changsha, Hunan, 410000
Yun Jiang, 0731-88651669, hnszlyy_gcp@163.com
Zhenyang Liu, Doctor
- Not yet recruiting
Changzhi People's Hospital
Changzhi
Na Si, +8615235503549, wana86211306@126.com
Jun Zhao, Doctor
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu
Ying Qian, 028-85422707, huaxigcp@163.com
Guowei Che, Doctor
- Not yet recruiting
Guizhou Provincial People'S Hospital
Guiyang, Guizhou, 550000
Jie Luo, 86851-85607982, 1654377211@qq.com
Shisheng Tan, Doctor
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Peng Du, +86(851)86752817, 19044055@qq.com
Jing Wang, Doctor
- Not yet recruiting
The First Hospital of China Medical University
Hangzhou
Yuqing Zhang, +8615140139773, cmu_lawyer@163.com
Funan Liu, Doctor
- Not yet recruiting
Zhejiang Provincial People'S Hospital
Hangzhou
Ying Wang, 0571-85893646, nancywangying@163.com
Yiping Mu, Doctor
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Jinlu Wang, 0451-86298192, sylcyj609@163.com
Yanqiao Zhang, Doctor
- Not yet recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250000
Yuanyuan Lv, 0531-67626063, ywb234@126.com
Yan Zhang, Doctor
- Not yet recruiting
Jiangxi Cance Hospital
Nanchang, Jiangxi, 330000
Yuan Gao, 0791-88331395, jxzljgb@126.com
Bo Yi, Doctor
- Recruiting
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, 200000
YiJu Gao, 8621-31587861, lcsyjg@zs-hospital.sh.cn
Tianshu Liu, Doctor
- Not yet recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110000
Yi Wang, 024-81916651, 564066425@qq.com
Yan Zhao, Doctor
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Heibei, 050000
Mingxia Wang, 0311-66696233, office_hb4th@126.com
Qun Zhao, Doctor
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Yu Zheng, +8613820049201, gcpcenter@tjmuch.com
Hongli Li, Doctor
- Not yet recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan
Chang Shu, 027-83663940, tongjigcp@163.com
Xianglin Yuan, Doctor
- Not yet recruiting
First Hospital of Shanxi Medical University
Xi'an
Yilai Song, 0351-4639072, lzgwyy@sina.com
Yusheng Wang, Doctor
- Not yet recruiting
Shanxi Cancer hospital (Shanxi Cancer institute)
Xi'an
Guozhong Wang, 0351-4651590, 15234165176@163.com
Wenhui Yang, Doctor
- Not yet recruiting
First Affiliated Hospital of Xiamen University
Xiamen
Mingxia Fan, 0592-2137232, xdfygcp@sina.com
Feng Ye, Doctor
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Sichuang, 610000
Xiaomu Wang, 0710-2811523, xyszxyygcp@163.com
Tienan Yi, Doctor
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Haijing Jiang, 0516-85802369, xyfy2369@163.com
Jun Song, Doctor
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Baoxia He, 0371-65587610, hnszlyylixiang@163.com
Jufeng Wang, Doctor
About this study
Official title: An Open-label Phase 2, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of ABSK061 and ABSK043 with or Without Chemotherapy in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations
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
Read the 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.
- Conditions
- HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma, Non-Small Cell Lung Cancer, Solid Tumors
- Being tested
- ABSK061 + ABSK043, ABSK061+ABSK043 in combination with CAPOX
- Medical subject headings
- Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK061 + ABSK043Drug
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.
ABSK061+ABSK043 in combination with CAPOXDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | HER2-Gastric/Gastroesophageal Junction Cancer Receives: Drug: ABSK061+ABSK043 in combination with CAPOX |
| Cohort 2 | Experimental | Urothelial carcinoma Receives: Drug: ABSK061 + ABSK043 |
| Cohort 3 | Experimental | Non-small cell lung cancer Receives: Drug: ABSK061 + ABSK043 |
| Cohort 4 | Experimental | Other solid tumors Receives: Drug: ABSK061 + ABSK043 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose limited toxicity (DLT)
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
Measured: At the end of Cycle 1 (each cycle is 28 days)
To assess the tolerability of ABSK061 + ABSK043 in combination with CAPOX in patients with first-line gastric/gastroesophageal junction cancer
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
Measured: At the end of Cycle 1 (each cycle is 21 days)
To assess the anti-tumor activity of ABSK061 + ABSK043 in combination with CAPOX as the primary endpoint of Progression-free survival (PFS) in first-line treatment of patients with metastatic/unresectable HER2-gastric/gastroesophageal junction cancer
PFS, as assessed by the investigator per RECIST v1.1
Measured: up to 5 years
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable urothelial cancer with FGFR2/3 activating alteration or FGFR3 overexpression, with Objective response rate (ORR) as the primary endpoint
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Measured: up to 5 years
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with non-small cell lung cancer withFGFR2/3 activating alteration or overexpression as the primary endpoint
PFS, as assessed by the investigator per RECIST v1.1
Measured: up to 5 years
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable other advanced solid tumors with FGFR2/3 activatingon alteration or overexpression as the primary endpoint
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Measured: up to 5 years
Secondary outcomes (8)
Overall Response Rate as Assessed by Investigator
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Measured: Up to 5 years
Duration of Response (DOR)
DOR is the duration from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study), or death, whichever comes first.
Measured: Up to 5 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with CR, PR or stable disease (SD).DCR is defined as the percentage of participants with CR, PR or stable disease (SD).
Measured: up to 5 years
Progression Free Survival (PFS)
PFS is the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
Measured: up to 5 years
Overall Survival (OS)
OS will be measured from the date of first dose of study drug to the date of the participant\'s death.
Measured: up to 5 years
Maximum observed concentration(Cmax)
To assess the PK profile of ABSK061 and ABSK043 after dosing of ABSK061 + ABSK043
Measured: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Area under the concentration-time curve(AUC)
To assess the PK profile of ABSK061 and ABSK043 after dosing of ABSK061 + ABSK043
Measured: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Time to maximum observed concentration(Tmax)
To assess the PK profile of ABSK061 and ABSK043 after dosing of ABSK061 + ABSK043
Measured: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start13 Nov 2024
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Gastric/Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tianshu Liu, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632262
- Sponsor's protocol ID
- ABSK061-201
- Status last verified
- Nov 2024
- First submitted
- 1 Oct 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 2, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of ABSK061 and ABSK043 with or Without Chemotherapy in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations
- ClinicalTrials.gov ID
- NCT06632262
- Acronym / sponsor ID
- ABSK061-201
- Conditions
- HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma, Non-Small Cell Lung Cancer, Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ABSK061+ABSK043 in combination with CAPOXHER2-Gastric/Gastroesophageal Junction Cancer |
| Cohort 2 | Experimental | Drug: ABSK061 + ABSK043Urothelial carcinoma |
| Cohort 3 | Experimental | Drug: ABSK061 + ABSK043Non-small cell lung cancer |
| Cohort 4 | Experimental | Drug: ABSK061 + ABSK043Other solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSK061 + ABSK043Participants 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. | Drug | Cohort 2, Cohort 3, Cohort 4 |
| ABSK061+ABSK043 in combination with CAPOXParticipants 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. | Drug | Cohort 1 |
Primary outcome
Incidence of Dose limited toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
To assess the tolerability of ABSK061 + ABSK043 in combination with CAPOX in patients with first-line gastric/gastroesophageal junction cancer
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
To assess the anti-tumor activity of ABSK061 + ABSK043 in combination with CAPOX as the primary endpoint of Progression-free survival (PFS) in first-line treatment of patients with metastatic/unresectable HER2-gastric/gastroesophageal junction cancer
Time frame: up to 5 years
PFS, as assessed by the investigator per RECIST v1.1
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable urothelial cancer with FGFR2/3 activating alteration or FGFR3 overexpression, with Objective response rate (ORR) as the primary endpoint
Time frame: up to 5 years
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with non-small cell lung cancer withFGFR2/3 activating alteration or overexpression as the primary endpoint
Time frame: up to 5 years
PFS, as assessed by the investigator per RECIST v1.1
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable other advanced solid tumors with FGFR2/3 activatingon alteration or overexpression as the primary endpoint
Time frame: up to 5 years
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
8 secondary outcomes
Overall Response Rate as Assessed by Investigator
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: Up to 5 years
Disease Control Rate (DCR)
Time frame: up to 5 years
Progression Free Survival (PFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
Maximum observed concentration(Cmax)
Time frame: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Area under the concentration-time curve(AUC)
Time frame: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Time to maximum observed concentration(Tmax)
Time frame: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tianshu Liu, Doctor principal investigator
Fudan University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABSK061 + ABSK043 and ABSK061+ABSK043 in combination with CAPOX in people with HER2-Gastric/Gastroesophageal Junction Cancer and Urothelial Carcinoma, run by Abbisko Therapeutics Co, Ltd at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Lu, Doctor (+86(21)68910052, clinical@abbisko.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose limited toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.