Trial Title:
A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
NCT ID:
NCT06298058
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced solid tumor
Her3-ADC
Safety
Efficacy
Pharmacokinetics
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This study is an open, multi-dose increasing single and multiple dose study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SIBP-A13 formulation for injection
Description:
SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group
is 1mg (intravenous infusion). Starting from the lowest dose, when the former does not
meet the termination criteria, then start the next dose group study until Maximum
Tolerated Dose (MTD). The study adopts a "3+3" dose increasing design. Administration
period: divided into single administration and multiple administration. Single dose
administration: The participants are administered a single dose on the first day for a
total of 21 days of observation, and complete the examinations and evaluations specify in
the protocol. If dose-limiting toxicity (DLT) does not occur, the participant enters a
multiple dosing period. Multiple administration: administration every 3 weeks.
Arm group label:
SIBP-A13
Other name:
Her3-ADC
Summary:
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and
determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Detailed description:
This study is an open, multi-dose increasing single and multiple doses increasing, dose
expanding, and indication expanding study to evaluate the safety, tolerability,
pharmacokinetics, immunogenicity, preliminary anti-tumor efficacy, and explore potential
biomarkers of SIBP-A13 in patients with advanced solid tumors.
This study is divided into three stages and is planned to be set up six dose groups,
including 1, 2, 4, 5, 6, and 8 mg/kg. The first stage is the dose escalation stage, with
a planned enrollment of 16-36 participants. The second stage is the dose expansion stage,
where two doses are selected to enter the dose expansion phase. 6-9 late-stage solid
tumor participants are enrolled in each dose group for dose expansion, and 12-18
participants are planned to be enrolled in the dose expansion phase. The third stage is
the indication expansion stage, where phase II recommended dose (RP2D) is preliminarily
determined based on the escalation and expansion of dosage in the early stage. Using RP2D
for indication expansion, we plan to expand three indication cohorts, with at least 30
participants selected for each cohort.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age range from 18 to 75 years old (including boundary values), regardless of gender.
- The clinical diagnosis of enrolled participants should meet the following criteria:
1. Dose escalation and dose expansion stage: Patients with locally advanced or
metastatic solid tumors confirmed by histology or cytology and judged by the
researcher to be unable to benefit from available standard treatment, or
intolerant.
2. Indications expansion stage:
- Queue 1: Non-small cell lung cancer (NSCLC) confirmed by histology or
cytology, with disease progression and EGFR mutation during or after
treatment with third generation TKI and platinum containing therapy.
- Queue 2: Breast cancer (BC) confirmed as HER3 positive by histology or
cytology after standard treatment failure.
- Queue 3: Patients with recurrent/metastatic advanced HNSCC confirmed by
histology or cytology, unsuitable for radical surgical resection, and
standard treatment failure.
- At least one measurable lesion must be selected as the target lesion (according to
RECIST v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI))
(for lesions that have previously received radiotherapy, only with clear progression
can they be selected as the target lesion).
- The patient has not previously used anti-HER3 antibodies or other HER3 targeted
treatments (such as Deparezumab (HER3-DXd).
- Drugs that have not received any form of topoisomerase I inhibitor in the past,
including antibody drug conjugates (ADCs) .
- ECOG score 0-1.
- Expected survival time ≥ 3 months.
- During the screening period, the main organ functions were basically normal (no
medical support such as blood transfusion, granulocyte colony-stimulating factor
(G-CSF), or other medical support was received within 14 days before the use of the
investigational drug):
Blood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10 9/L, platelet (PLT) count
≥ 90 × 10 9/L, hemoglobin (HGB) ≥ 90 g/L.
- Women of childbearing age during the screening period who have a negative blood
pregnancy test and are capable of reproduction (including male participants) have no
pregnancy plan and voluntarily take effective contraceptive measures during the
trial period and within 6 months after the last dose.
- Voluntarily participate in this study and sign an informed consent form.
Exclusion Criteria:
- Participants with the following tumors:
- The participant has had other malignant tumors that have not been cured within
the past 5 years (excluding malignant tumors that have been clearly cured, such
as thyroid cancer, cured basal cell carcinoma of the skin, and cervical
carcinoma in situ).
- The participant has untreated imaging confirmed central nervous system
metastasis.
- Meningeal metastases.
- Patients with brain metastases who have received systematic or curative brain
metastasis treatment (radiotherapy or surgery) in the past, have been confirmed
stable by imaging for at least 4 weeks, and have stopped systemic hormone,
antiepileptic, convulsive drugs, and other treatments for more than 2 weeks
without clinical symptoms can be enrolled.
- Participants with a history of previous treatment or surgery, or those who received
the following anti-tumor treatments during the planned trial period:
- Patients who accepted the instructions clearly containing traditional Chinese
patent medicines and simple preparations with anti-tumor effect within 2 weeks
before the first administration;
- Patients undergoing adjuvant therapy within 6 months after surgery;
- Patients who have not recovered from the toxicity of the previous anti-tumor
treatment to normal or ≤ level 1 (excluding hair loss);
- Patients who have undergone major surgery, radiation therapy, biological
therapy, or chemotherapy within 4 weeks prior to their first administration, or
who have received systemic treatment such as unhealed surgical wounds, ulcers
or fractures, or other clinical trial drugs.
- Patients who plan to receive any other anti-tumor treatment (chemotherapy,
radiation therapy, immunotherapy, cytokine therapy other than erythropoietin)
during the trial period should be excluded (excluding testosterone lowering
therapy for prostate cancer patients).
- The dose (prednisone>10 mg/d or equivalent) at which immunosuppressive effects
are achieved by receiving immunosuppressive agents or systemic corticosteroids
within one week prior to the use of the investigational drug.
- Participants with a history of previous illnesses or laboratory tests that show the
following abnormalities:
- Individuals with abnormal coagulation function and a tendency to bleed, or who
are undergoing thrombolysis or anticoagulation treatment or have lost blood or
donated more than 400 mL within 2 months prior to administration.
- Have a history of immunodeficiency, including HIV testing positive, or other
acquired or congenital immunodeficiency diseases, or a history of organ
transplantation.
- Have a clear history of neurological or psychiatric disorders, including
epilepsy or dementia.
- Screening period for syphilis spiral antibody positive individuals; Individuals with
active HBV and HCV infections; Except those with stable hepatitis B (DNA titer below
the lower detection limit) and cured hepatitis C (HCV RNA test negative) after drug
treatment.
- Patients with ascites, pleural effusion, and pericardial effusion accompanied by
clinical symptoms during the screening period who require drainage, or those who
have undergone serous cavity drainage within 4 weeks before the first
administration.
- The screening period is accompanied by severe, progressive, or uncontrollable
diseases, and the researcher's evaluation determines that the participation of the
participants in the study will increase the risk. Including but not limited to:
- Cerebrovascular accidents or transient ischemic attacks (within the first 6
months of screening); Suffering from heart disease judged by the researcher as
unsuitable for participation in this trial, with a severity of cardiac or renal
dysfunction ≥ Level II.
- According to the researcher's judgment, there are accompanying diseases that
seriously endanger patient safety or affect patient completion of the study.
1. Hypertension that cannot be controlled clinically.
2. Diabetes with poor drug control.
3. Clinically significant thyroid diseases judged by researchers as unsuitable for
inclusion.
4. Serious infections that occurred within 4 weeks prior to initiating research
treatment.
- Individuals with a history of severe allergies to protein products, Chinese hamster
ovary cell (CHO) cell products, and other recombinant human or humanized antibodies,
or to the components of the investigational drug.
- Pregnant and lactating women.
- Patients deemed unsuitable for inclusion by researchers.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou, Doctor
Start date:
May 9, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Shanghai Institute Of Biological Products
Agency class:
Industry
Collaborator:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Institute Of Biological Products
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06298058
