To hear about similar clinical trials, please enter your email below
Trial Title:
HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors
NCT ID:
NCT06336707
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Bevacizumab
Carboplatin
Conditions: Keywords:
HS-20089
B7-H4
Antibody-drug Conjugate
Combination Therapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20089
Description:
Intravenous infusion
Arm group label:
HS-20089 and Adebrelimab
Arm group label:
HS-20089 and Bevacizumab
Arm group label:
HS-20089, Adebrelimab and cisplatin / carboplatin
Arm group label:
HS-20089, Bevacizumab and cisplatin / carboplatin
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Intravenous infusion
Arm group label:
HS-20089 and Adebrelimab
Arm group label:
HS-20089, Adebrelimab and cisplatin / carboplatin
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Intravenous infusion
Arm group label:
HS-20089 and Bevacizumab
Arm group label:
HS-20089, Bevacizumab and cisplatin / carboplatin
Intervention type:
Drug
Intervention name:
Cisplatin / carboplatin
Description:
Intravenous infusion
Arm group label:
HS-20089, Adebrelimab and cisplatin / carboplatin
Arm group label:
HS-20089, Bevacizumab and cisplatin / carboplatin
Summary:
HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1
anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a
protease-cleavable linker, with an average drug-to-antibody ratio of about 6.
This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability,
pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents
(Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects
with advanced solid tumors.
Detailed description:
This study contains four combination therapy cohorts, each consisting of a dose
exploration part and a dose expansion part.
The dose exploration part will explore the corresponding optimal dose level of HS-20089
in each combination therapy. The dose expansion part will be conducted at 1 or 2 safe and
potentially effective dose levels in subjects with selected tumors in each cohort.
The cohorts may be adjusted based on the observed clinical results, translational
medicine data and research progress in the field.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males or females aged 18 years or older (≥18 years).
2. Patients diagnosed with pathologically confirmed advanced solid tumors.
3. Subjects have at least one target lesion as assessed per the RECIST 1.1. Patients
with only brain and/or bone lesions as target lesions are ineligible.
4. Agree to provide fresh or archival tumor tissue
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and
no deterioration within 2 weeks before the first dose.
6. Have a life expectancy of at least 12 weeks.
7. Female subjects of childbearing potential are willing to take appropriate
contraceptive measures and should not breastfeed from signing the informed consent
until 6 months after the last dose; male subjects must agree to use barrier
contraception (i.e. condoms) from signing the informed consent to 6 months after the
last dose.
8. Female subjects must have a negative pregnancy test within 7 days prior to the first
dose (for subjects with tumor related abnormal elevation of human chorionic
gonadotropin [HCG], an ultrasound of uterus and appendages should be performed
within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk
for pregnancy.
9. Subject must be voluntarily enrolled in this clinical trial, be able to understand
the study procedures and to sign written informed consent.
Exclusion Criteria:
1. Have received or is currently receiving the following treatment: B7-H4-targeted
therapies; Have received any of cytotoxic chemotherapy drugs, investigational drugs,
anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days
prior to the first dose of study drug; or need to continue these drugs during the
study.
2. Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse
Events due to prior anti-tumor therapy.
3. Presence of pleural/abdominal effusion requiring clinical intervention.
4. Known history of other primary malignancy.
5. Evidence of brain metastasis and/or cancerous meningitis
6. Inadequate bone marrow reserve or hepatic/renal functions.
7. Cardiological examination abnormality.
8. Severe, uncontrolled or active cardiovascular disorders.
9. Serious or poorly controlled diabetes.
10. Serious or poorly controlled hypertension.
11. Clinically significant bleeding symptoms or significant bleeding tendency within 1
month prior to the first dose of study treatment.
12. Serious infections within 4 weeks prior to the first dose.
13. Have received systemic glucocorticoid therapy for more than 7 days within 28 days
prior to the first dose study treatment, or require chronic (≥ 7 days) use of
systemic glucocorticoids during the study, or have other acquired, congenital
immunodeficiency disorders, or a history of organ transplantation.
14. Presence of active infectious diseases such as hepatitis B, hepatitis C,
tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
15. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more
severe cirrhosis.
16. Any moderate or severe lung diseases that may interfere with the detection and
treatment of drug-related pulmonary toxicity or may seriously affect respiratory
function.
17. History of severe neurological or psychiatric disorder.
18. Pregnant or breast-feeding women or women who intend to become pregnant during the
study.
19. Attenuated live vaccination within 4 weeks prior to the first dose.
20. Subjects with autoimmune disease that is active or is likely to recur.
21. Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal
perforation, or abdominal abscess, or with symptoms/signs of intestinal obstruction
within 6 months prior to the first dose of study drug.
22. Subjects unlikely to comply with study procedures, restrictions and requirement as
determined by the investigator.
23. Subjects with any condition that jeopardizes the safety of the patient or interferes
with the assessment of the study, as judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Address:
City:
Shanghai
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ding Ma, PhD
Phone:
(0086)13886090620
Email:
dma@tjh.tjmu.edu.cn
Start date:
April 11, 2024
Completion date:
April 8, 2028
Lead sponsor:
Agency:
Hansoh BioMedical R&D Company
Agency class:
Industry
Source:
Hansoh BioMedical R&D Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06336707