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Recurrent or Metastatic, Advanced Solid TumorsPhase 1NCT06292858

Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors

A Phase 1 study testing IMB071703 injection in people with Recurrent or Metastatic, Advanced Solid Tumors, run by Beijng Immunoah Pharma Tech Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IMB071703 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteChina
Study dates
24 Feb 2023to Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Zhongyi Shen, Doctor contact

010-86229435

shenzhongyi@immunoah.cn

Xin Gao, Doctor contact

010-86229435

gaoxin@immunoah.cn

China1 site, 1 recruiting

  • Department of Oncology, Shanghai East Hospital, Tongji University

    Shanghai, Shanghai Municipality, 200120

    Ye Guo, Doctor

    Recruiting

Other trials in China

About this study

Official title: 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

A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors

Being tested
IMB071703 injection
Medical subject headings
Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMB071703 injectionDrug

    Intratumoral injection

Study groups in NCT06292858
Study groupRoleWhat they receive
ExperimentalExperimentalPart 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.
Receives: Drug: IMB071703 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events/serious adverse event related with IMB071703 injection

    Measured: From enrollment until 90 days after the last dose

  2. Dose-limiting toxicity (DLT)

    Measured: From the first dose of study drug up to 3 weeks

  3. Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection

    Measured: From first dose to disease progression or end of study, an average of 2 years

Secondary outcomes (8)

  1. Maximum measured plasma concentration (Cmax) of IMB071703 injection.

    Measured: From first dose until 90 days after the last dose

  2. Time to maximum plasma concentration (Tmax) of IMB071703 injection.

    Measured: From first dose until 90 days after the last dose

  3. Half-life (T1/2) of IMB071703 injection.

    Measured: From first dose until 90 days after the last dose

  4. Immunogenicity profile of IMB071703 injection.

    Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.

    Measured: From first dose until 90 days after the last dose

  5. Objective Response Rate (ORR)

    Measured: From first dose to disease progression or end of study, an average of 2 years

  6. Duration of Response (DOR)

    Measured: From first dose to disease progression or end of study, an average of 2 years

  7. Disease control rate (DCR)

    Measured: From first dose to disease progression or end of study, an average of 2 years

  8. Progression free survival (PFS)

    Measured: From first dose to disease progression or end of study, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start24 Feb 2023
  3. Primary completionApr 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06292858
Sponsor's protocol ID
IMB071703-101
Status last verified
Feb 2024
First submitted
20 Feb 2024
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMB071703 injection in people with Recurrent or Metastatic, Advanced Solid Tumors, run by Beijng Immunoah Pharma Tech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhongyi Shen, Doctor (010-86229435, shenzhongyi@immunoah.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events/serious adverse event related with IMB071703 injection (time frame: From enrollment until 90 days after the last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06292858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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