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

Beijng Immunoah Pharma Tech Co., Ltd.1 site in 1 country93 target enrollmentFebruary 24, 2023

ConditionsRecurrent or Metastatic, Advanced Solid Tumors

InterventionsIMB071703 injection

DrugsIMB071703 injection

Overview

Phase: Phase 1
Intervention: IMB071703 injection
Conditions: Recurrent or Metastatic, Advanced Solid Tumors
Sponsor: Beijng Immunoah Pharma Tech Co., Ltd.
Enrollment: 93
Locations: 1
Primary Endpoint: Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 24, 2023

End Date

August 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Beijng Immunoah Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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-
•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.

Arms & Interventions

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.

Intervention: IMB071703 injection

Outcomes

Primary Outcomes

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

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

Time Frame: From enrollment until 90 days after the last dose

Dose-limiting toxicity (DLT)

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

Secondary Outcomes

Maximum measured plasma concentration (Cmax) of IMB071703 injection.(From first dose until 90 days after the last dose)
Time to maximum plasma concentration (Tmax) of IMB071703 injection.(From first dose until 90 days after the last dose)
Half-life (T1/2) of IMB071703 injection.(From first dose until 90 days after the last dose)
Objective Response Rate (ORR)(From first dose to disease progression or end of study, an average of 2 years)
Immunogenicity profile of IMB071703 injection.(From first dose until 90 days after the last dose)
Duration of Response (DOR)(From first dose to disease progression or end of study, an average of 2 years)
Disease control rate (DCR)(From first dose to disease progression or end of study, an average of 2 years)
Progression free survival (PFS)(From first dose to disease progression or end of study, an average of 2 years)