- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06292858
Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors
A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Patients With Recurrent or Metastatic, Advanced Solid Tumors
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Zhongyi Shen, Doctor
- Phone Number: 010-86229435
- Email: shenzhongyi@immunoah.cn
Study Contact Backup
- Name: Xin Gao, Doctor
- Phone Number: 010-86229435
- Email: gaoxin@immunoah.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200120
- Recruiting
- Department of Oncology, Shanghai East Hospital, Tongji University
-
Contact:
- Ye Guo, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Voluntarily participating in this clinical study and signing a written informed consent form and being able to comply with clinical visits and study-related procedures.
- Male or female subjects ≥ 18 and ≤ 75-year age when signing the informed consent form.
- Expected survival time of not less than 3 months (as judged by the investigator)
- Subjects with histologically or cytologically confirmed advanced malignant solid tumors, ie, recurrent or metastatic, advanced solid tumors, who have failed the standard therapy or who are not suitable for standard therapy at this stage.
- Subjects are able to provide tumor tissue samples (archived tumor tissue within one year as much as possible or fresh specimens of core needle aspiration).
- According to RECIST V1.1 criteria, (dose escalation phase), at least one evaluable tumor lesion; (dose expansion phase) at least one measurable tumor lesion (tumor lesions located in the previously radiotherapy area or other localized regional treatment area are generally not considered measurable unless the lesion has clearly progressed or persists after three months of radiotherapy).
- Patients are required to have injectable lesions that meet the current dosage administered in the dose level. Superficial lesions are preferred, and deep lesions that can be injected under the ultrasound/CT guidance [injectable lesions cannot have previously been treated with radiotherapy or other intratumoral injections, and lesions with a high risk of bleeding (eg, adjacent to large blood vessels, the presence of large blood vessels in the tumor or vascular encasement) should not be considered injectable lesions].
- Eastern Cooperative Oncology Group (ECOG) physical performance score 0-1.
- Bone marrow reserve and organ function must meet the following requirements (no blood transfusion and no supportive treatment with blood components or granulocyte colony cytokines within 14 days before the first treatment).
Exclusion Criteria:
Subjects with any of the following conditions are not eligible for this study:
- Received or are receiving any anti-CD40 and/or CD137 therapy.
- Subjects who have received or plan to receive allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/bone marrow transplantation.
- Patients with active autoimmune diseases
- Used live attenuated vaccines within 4 weeks before the first dosage of study drug.
- Received immunotherapy and experienced ≥ Grade 3 irAEs or ≥ Grade 2 immune-related myocarditis.
- Used immunomodulatory drugs within 14 days before the first dosage of study drug, including but not limited to thymosin, interleukin-2, interferon, etc.
- Received systemic corticosteroids (prednisone > 10 mg/day or equivalent dosage of similar drug) or other immunosuppressive agents within 14 days before the first dosage of study drug (except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed; short-term use of corticosteroids for prophylaxis, eg, to prevent contrast agent from allergy).
- Received anti-tumor therapy such as systemic chemotherapy, radiotherapy, targeted therapy, endocrine therapy, biological therapy and immunotherapy within 4 weeks before the first dosage of study drug, except for the following items: nitrosourea or mitomycin C within 6 weeks before the first dosage of study drug; oral fluoropyrimidines, small-molecule targeted drugs and traditional Chinese medicines with anti-tumor indications within 2 weeks before the first dosage of study drug; local palliative radiotherapy within 2 weeks before the first dosage of study drug;
- Received other unmarketed study drugs or treatments within 4 weeks before the first dosage of investigational drug.
- Received major organ surgery (excluding diagnostic needle biopsy treatment) or significant trauma within 4 weeks before the first dosage of study drug, or the need for elective surgery during the study.
- Serious wounds/ulcers/fractures that cannot be healed within 4 weeks before the first dosage of study drug.
- The adverse events caused by previous anti-tumor therapy have not recovered to CTCAE 5.0 Grade ≤ 1 before the administration (except for toxicity that is judged by the investigator to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity and stable hypothyroidism with hormone replacement therapy).
- Metastases to central nervous system or metastases to meninges.
- History of other malignancy within 5 years of the enrollment (except for the following neoplastic diseases: adequately treated papillary thyroid carcinoma, cervix carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery).
- Active infection requiring systemic intravenous anti-infective therapy or fever of unknown origin exceeding 38℃ at enrollment.
- Receiving therapeutic dosages of anticoagulants (except prophylactic anticoagulation) or history of bleeding ≥ Grade 3 within 3 months.
Subjects meet any of the following:
- HIV infection (HIV antibody positive)
- Active HBV infection (HBV DNA > 500 copies/mL or 100 IU/mL)
- Active HCV infection (HCV antibody positive, HCV-RNA positive)
- Treponema Pallidum infection (TP-Ab positive)
- Subjects with known active tuberculosis (TB)
History of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- Subjects with severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block.
- According to New York Heart Association (NYHA) criteria, patients with grade II-IV cardiac insufficiency.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other Grade 3 or higher cardiovascular and cerebrovascular events within 6 months before the first dosage.
- Clinically uncontrolled hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg despite optimal anti-hypertensive therapy).
- Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, uncorrectable hypokalemia, congenital long QT syndrome, need to use any concomitant medication known to prolong the QT interval.
- Clinically uncontrolled third space fluid
- Known ≥ Grade 2 uveitis and retinopathy.
- Subjects who are known to be allergic to IMB071703 injection or its excipients
- Subjects with known, documented, or suspected drug abuse
- Pregnant or lactating women
- Subjects who, in the opinion of the investigator, have psychiatric disorders, poor compliance, inability to tolerate venous blood sampling, history of other serious systemic diseases, or other reasons that would make them inappropriate for participating in this clinical study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Part A: Dose escalation phase Six dose levels of IMB071703 injection are planned in Part A, 1 subject in the first dose level (accelerated titration design), 3 subjects in the 2nd through 6th dose levels separately (conventional Fibonacci 3+3 design). 19 to 33 subjects are expected to enroll. Part B: Dose/cohort expansion phase 1 to 2 dose levels of subjects with 1 to 2 tumor types are tentatively planned; a total of up to 15 subjects are included in each dose level for each tumor type, 15 to 60 subjects are expected to enroll. |
Intratumoral injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-limiting toxicity (DLT)
Time Frame: From the first dose of study drug up to 3 weeks
|
From the first dose of study drug up to 3 weeks
|
Incidence of adverse events/serious adverse event related with IMB071703 injection
Time Frame: From enrollment until 90 days after the last dose
|
From enrollment until 90 days after the last dose
|
Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection
Time Frame: From first dose to disease progression or end of study, an average of 2 years
|
From first dose to disease progression or end of study, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
|
From first dose to disease progression or end of study, an average of 2 years
|
|
Duration of Response (DOR)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
|
From first dose to disease progression or end of study, an average of 2 years
|
|
Disease control rate (DCR)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
|
From first dose to disease progression or end of study, an average of 2 years
|
|
Progression free survival (PFS)
Time Frame: From first dose to disease progression or end of study, an average of 2 years
|
From first dose to disease progression or end of study, an average of 2 years
|
|
Maximum measured plasma concentration (Cmax) of IMB071703 injection.
Time Frame: From first dose until 90 days after the last dose
|
From first dose until 90 days after the last dose
|
|
Time to maximum plasma concentration (Tmax) of IMB071703 injection.
Time Frame: From first dose until 90 days after the last dose
|
From first dose until 90 days after the last dose
|
|
Half-life (T1/2) of IMB071703 injection.
Time Frame: From first dose until 90 days after the last dose
|
From first dose until 90 days after the last dose
|
|
Immunogenicity profile of IMB071703 injection.
Time Frame: From first dose until 90 days after the last dose
|
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
|
From first dose until 90 days after the last dose
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMB071703-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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