Trial Title:
Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors
NCT ID:
NCT06571422
Condition:
Advanced Malignant Solid Tumors
Conditions: Official terms:
Neoplasms
Bevacizumab
Conditions: Keywords:
Solid Tumors
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:
WJ47156
Description:
Monotherapy study: participate will recepit WJ47156 monotherpy with 3 dose groups;
Combination therapy study: participate will recepit WJ47156 and other study drug if in
the combination therapy period
Arm group label:
WJ47156
Intervention type:
Drug
Intervention name:
JS001+Bevacizumab
Description:
Participants in Cohort1 of combination therapy phase will receive WJ47156 plus
toripalimab and bevacizumab.Toripalimab and bevacizumab are administered intravenously.
Arm group label:
WJ47156+JS001+Bevacizumab
Other name:
Toripaliman injection+Bevacizumab Injection
Summary:
This study is an open-label, dose-escalation and expansion, Phase I clinical study to
evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity
of WJ47156 monotherapy and in combination with toripalimab in patients with advanced
malignant solid tumors. The study consists of two parts, including monotherapy (Part 1)
and combination therapy (Part 2).
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. Male or female, 18 to 75 years old (inclusive) at the time of signing the ICF;
2. Patients with histologically or cytologically confirmed advanced malignant solid
tumors；
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. Life expectancy ≥ 12 weeks;
5. At least one measurable lesion according to RECIST 1.1;
6. Adequate organ function ；
7. Female or male patients of childbearing potential must agree that they have no
intention to become pregnant during the study and for 6 months after the last dose,
and to use highly effective contraceptive methods with their partners; );
8. Voluntary participation with full informed consent by signing an written informed
consent, and with good compliance.
Exclusion Criteria
1. CNS metastasis；
2. Pleural effusion, peritoneal effusion or pericardial effusion with clinical symptoms
or requiring repeated treatment (e.g., puncture or drainage);
3. Unable to swallow tablets, intestinal obstruction, or other factors affecting the
administration and gastrointestinal absorption of tablets
4. For the combination therapy, patients will not be enrolled in this study if they
meet any of the following criteria:
（1）Imaging findings at screening showing tumor encasement of a major vessel or
significant necrosis and cavity, which may lead to a hemorrhagic risk as judged by the
investigator; （2）Patients with active autoimmune diseases requiring systemic treatment
(e.g., corticosteroids or immunosuppressive drugs) within 2 years prior to the first
dose, including but not limited to systemic systemic lupus erythematosus, multiple
sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However,
hypothyroidism, hypoadrenalism or hypopituitarism controlled only by hormone replacement
therapy, Type I diabetes mellitus not requiring systemic treatment, psoriasis or vitiligo
are allowed; （3）Previously treated with anti-PD-1/L1 therapy; （4）History of interstitial
lung disease or previous history of non-infectious pneumonia treated with
corticosteroids, or evidence of active pneumonia on imaging at screening;
（5）Gastrointestinal perforation, fistula, abdominal abscess and ulcerative disease or
history of digestive system ulcerative disease within 6 months prior to the first dose
(patients with stable ulcer as assessed by the investigator may be considered for
enrollment); （6）Presence of serious, unhealed, or open wounds, active ulcers, or
untreated fractures; （7）History of gastrointestinal bleeding within 6 months prior to
enrollment, or clear tendency of gastrointestinal bleeding (including hemorrhagic risk of
severe esophageal-gastric varices, locally active digestive tract ulcerative lesion, and
persistent positive fecal occult blood); （8）Clinically significant hemoptysis or tumor
bleeding for any reason within one month prior to the first dose; （9）History of obvious
bleeding tendency or severe coagulation dysfunction; （10）Severe drug-related adverse
events leading to permanent discontinuation of the drug product or bevacizumab or its
analogues; （11）Use of antiplatelet therapy or anticoagulant therapy for treatment within
14 days prior to the first dose; （12）Long-term treatment with nonsteroidal
anti-inflammatory drugs is permitted for brief periods of time to relieve symptoms such
as fever or pain.
5. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood
pressure > 100 mmHg) or history of hypertensive crisis or hypertensive
encephalopathy; 6. Severe cardiovascular disease, including but not limited to,
myocardial infarction, severe/unstable angina, congestive heart failure (New York
Heart Association [NYHA] class ≥ 2), clinically significant supraventricular or
ventricular arrhythmia requiring drug intervention, aortic aneurysm requiring
surgical repair, any arterial thrombosis/embolism event, Grade 3 or higher (Common
Terminology Criteria for Adverse Events [CTCAE] v5.0) venous thrombosis/embolism
event, transient ischemic attack, cerebral vascular accident; Left ventricular
ejection fraction (LVEF) < 50% by echocardiography. Corrected QT interval (QTc) >
480 ms (calculated using the Fridericia method; if QTc is abnormal, measure 3 times
at an interval of 2 minutes and use the average).
7. Serious infection (CTCAE Grade > 2) within 28 days prior to the first dose, such as
serious pneumonia, bacteremia, infection and complications requiring
hospitalization; or active infection or unknown cause of fever (>38.5℃) requiring
systemic anti-infection treatment within 2 weeks prior to the first dose (as judged
by the investigator, patients with tumor-induced fever can be enrolled);
8. Presence of active tuberculosis, hepatitis B (positive for hepatitis B surface
antigen [HBsAg] and HBV DNA higher than the lower limit of detection in the study
site), hepatitis C (positive for HCV antibody [HCVAb] and HCV RNA higher than the
lower limit of detection in the study site);
9. History of immunodeficiency, including human immunodeficiency virus (HIV) positive
test, or history of known allogeneic organ transplantation or allogeneic
hematopoietic stem cell transplantation;
10. History of another primary malignant tumor, with the exception of malignant tumors
(e.g., basal cell carcinoma of skin and squamous cell carcinoma of skin) who have
received potentially curative therapy (more than 5 years) without known active
disease prior to the first dose, without potential risk for recurrence ;
11. Toxicity of previous antitumor therapy has not been recovered to CTCTAE Grade ≤ 1 or
to the level specified in the inclusion/exclusion criteria, with the exception of
the following: related toxicities that are well controlled as judged by the
investigator and do not affect the safety and compliance of the study treatment, and
can be screened after confirmation by the Sponsor;
12. Prior use of the following drugs or therapies before the first dose:
1. Having received chemotherapy, immunotherapy or other anti-tumor therapy or other
investigational drug within 21 days prior to the first dose, or having received oral
fluorouracil, small-molecule targeted drugs or Chinese herbal products for antitumor
indications within 14 days prior to the first dose;
2. Major surgery, radiation therapy (with the exception of palliative radiation to a
localized bone or brain lesion, which may be completed up to 14 days prior), or any
other minor surgical procedure, excluding placement of vascular access devices,
within 28 days prior to the first dose; and any biopsy or other minor procedure
within 7 days prior to the first dose.
3. In the combination therapy phase, patients who have received systemic treatment with
corticosteroids (more than 10 mg/day prednisone or equivalent) or other
immunosuppressants within 2 weeks prior to the first dose are allowed to use inhaled
or topical steroids or systemic prednisone ≤10 mg/day and equivalent drug product;
4. Having received any live vaccine or attenuated live vaccine within 28 days prior to
the first dose or requiring to be vaccinated with live vaccine or attenuated live
vaccine during the study (only for patients in combination therapy phase);
13. Patients who, in the opinion of the investigator, may be at increased risk of
participation in the study due to other serious physical or mental diseases or
abnormal laboratory examination, or may affect the compliance with treatment or
interfere with the study results, and are not suitable for participation in
this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruihua Xu, Professor
Phone:
13922206676
Email:
xurh@sysucc.org.cn
Contact backup:
Last name:
Danyun Ruan, Professor
Phone:
13760611470
Email:
ruandy1@sysucc.org.cn
Start date:
October 23, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Sponsor GmbH
Agency class:
Other
Source:
Shanghai Junshi Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06571422
