Trial Title:
A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors
NCT ID:
NCT05991583
Condition:
Advanced Malignant Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced Malignant Tumors
B7-H3
IL-10
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBB0979
Description:
IBB0979 should be subcutaneous injected，qw
Arm group label:
Phase IIa - Clinical Exploratory Stage
Arm group label:
Phase Ia - Dose escalation
Arm group label:
Phase Ib - Dose extension
Summary:
This is a Phase 1/2, open-label, dose escalation and dose expansion study designed to
characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor
activity of IBB0979 in previously treated patients with locally advanced or metastatic
solid tumors.
Detailed description:
The study consists of Dose Escalation Phase, Dose Expansion Phase and Clinical
Exploration Phase.
Dose Escalation Phase：This phase is an open-label, non-randomized, multicenter,
dose-escalation study. From the starting dose of 0.01 mg/kg, an accelerated titration
combined with a "3+3" design will be adopted.
Dose Expansion Phase：The application of Dose Expansion Phase can be discussed by
investigator and sponsor based on data obtained in Dose Escalation Phase. This phase is
an open-label, non-randomized, multicenter study. 6 patients with locally advanced or
metastatic solid tumors are expected to be enrolled at DRDE. Each treatment cycle is
defined as 21 days, patient may receive treatment until withdrawal or Treatment
Discontinuation.
Clinical Exploration Phase：After completing the dose escalation and expansion studies,
the indication and study population can be discussed by the investigator and sponsor
based on the efficacy and safety data that have been obtained.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, 18 to 80 years old.
2. With histologically or cytologically confirmed locally advanced or metastatic solid
malignant tumors, either (a) failed prior standard therapy, (b) for which no
standard therapy exists, or (c) standard therapy is not considered appropriate.
3. There is at least one assessable tumor lesion in the Dose Escalation Phase and at
least one measurable lesion in the Dose Expansion Phase According to RECIST 1.1
(tumor lesions located in the previous radiation therapy area or other local
regional treatment area generally not be considered as measurable lesions, unless
the lesion has progression or persists after three months of radiation therapy).
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy ≥ 3 months.
6. Adequate organ functions:
- Hematologic system (no transfusion or hematopoietic-stimulating factor therapy
within 14 days): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count
(PLT) ≥ 90 × 109/L, hemoglobin (HGB) ≥ 90 g/L.
- Liver function: total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal
values (ULN), except for Gilbert's syndrome; alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN, liver metastases
or liver cancer patients with ALT and AST ≤ 5.0 × ULN.
- Renal function: estimated creatinine clearance (Ccr) ≥ 50 mL/min
(calculated according to the Cockcroft-Gault formula).
- Thrombin function: international normalized ratio of prothrombin
(INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT)
≤ 1.5 × ULN.
7. Eligible patients with fertility (male and female) must agree to use reliable
contraceptive measures (include hormonal contraceptives, barrier contraception or
abstinence) with their partners from the time of consent through 90 days after
discontinuation of investigational product administration. Female patients of
childbearing potential (not surgically sterilized and between menarche and 1- year
postmenopause) must have a negative serum pregnancy test within 7 days prior to the
initiation of investigational product administration.
8. Ability to provide informed consent and documentation of informed consent prior to
initiation of any study-related tests or procedures.
Exclusion Criteria:
1. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient
contained in the drug or vehicle formulation for IBB0979.
2. History of anti-tumor therapy (chemotherapy within 3 weeks or radiotherapy,
biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the
initiation of investigational product administration, with the following exceptions:
- Nitrosourea or mitomycin C should be within 6 weeks prior to the initiation of
investigational product administration.
- Oral fluoropyrimidines and small molecule targeted drugs should be within
2 weeks prior to the initiation of investigational product administration.
3. History of any un-marketed investigational product or therapy within 4 weeks prior
to the initiation of investigational product administration.
4. History of major organ surgery (with exception of aspiration biopsy) or significant
trauma within 4 weeks prior to the initiation of investigational product
administration, or selective operation is required during the trial.
5. History of systemic corticosteroids (prednisone >10 mg per day or equivalent) or
other immune-suppressive drugs within the 14 days prior to the initiation of
investigational product administration. Steroids for topical, ophthalmic,
intraarticular, inhaled or nasal administration are allowed.
6. Treatment with immunomodulatory agents, including but not limited to thymosin,
interleukin-2 and interferon within 14 days prior to the initiation of
investigational product administration.
7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of
investigational product administration.
8. History of prior allogeneic stem-cell or solid organ transplantation.
9. The adverse effects of previous anti-tumor therapy have not yet returned to ≤ Grade
1 (NCI-CTCAE 5.0) or rules of the inclusion criteria (with exception of that the
investigator judged to be without safety risks, such as hair loss, Grade 2
peripheral neurotoxicity, stable hypothyroidism with hormone replacement therapy,
etc.).
10. Active brain or leptomeningeal metastases with clinical symptoms. Patients with
brain metastases are eligible if these have been treated and MRI or CT shows no
evidence of progression for at least 8 weeks after treatment completion and within 4
weeks prior to the initiation of investigational product.
11. Evidence of active infection requiring intravenous anti-infective therapy.
12. Active hepatitis B (HBsAg-positive, and HBV-DNA> 500 IU/mL or lower limit of study
site [only if the lower limit of study site is above 500 IU/mL]), active hepatitis C
(HCV-RNA> lower limit of study site).
13. Currently has interstitial lung disease (with exception of radiation pulmonary
fibrosis that requires no hormone therapy).
14. History of severe cardiovascular and cerebrovascular diseases, including but not
limited to:
- Severe heart rhythm or conduction abnormalities, such as ventricular
arrhythmias requiring clinical intervention, II/III-degree atrioventricular
block, etc.
- The mean QT interval (QTcF) > 470 ms corrected by Fridericia's method.
- Acute coronary syndrome, congestive heart failure, aortic dissection,
stroke or other cardiovascular and cerebrovascular events of ≥ grade
3 within 6 months prior to the initiation of investigational product.
- Congestive heart failure (New York Heart Association [NYHA]
class ≥ grade II) or left ventricle ejection fraction (LVEF) <
50%, or other structural heart disease at high risk by the
investigator.
- Clinically uncontrolled hypertension.
15. Active or suspected autoimmune diseases (such as systemic lupus erythematosus,
rheumatoid arthritis, vasculitis, etc.), with exception of clinically stable
autoimmune thyroid disease, type I diabetes, vitiligo, cured atopic dermatitis in
children and psoriasis without systemic treatment (within the past 2 years).
16. History of ≥ grade 3 immune-related adverse events (irAE) or Grade 2
immune-associated myocarditis accompanied with immunotherapy, with exception of ≥
Grade 3 immune-associated thyrotoxicosis.
17. History of another malignancy or a concurrent malignancy. Exceptions include
patients who have been disease free for two years for non-melanoma skin cancer,
localized prostate cancer or carcinoma in situ (e.g., cervical cancer in situ), etc.
18. Clinically uncontrolled effusion in the third space, which is unsuitable for
participation in the study by the investigator.
19. Known alcohol or drug dependence.
20. History of mental disorder or poor adherence.
21. The female patient who is pregnant or breastfeeding. History of other severe
systemic disease, or any issue that in the opinion of the investigator, would
contraindicate the patient's participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li, master
Phone:
+86-021-38804518
Email:
lijin@csco.org.cn
Start date:
June 28, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
SUNHO（China）BioPharmaceutical CO., Ltd.
Agency class:
Industry
Source:
SUNHO（China）BioPharmaceutical CO., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991583
