A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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This is a study to evaluate the safety and tolerability of the study drug HBM1020 which contains two parts. Part 1 will enroll solid tumor participants and Part 2 will enroll renal cell carcinoma (RCC) and colorectal adenocarcinoma (CRC).

Detailed Description
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This is a study to evaluate the safety and tolerability of the study drug HBM1020, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM1020. The study will also look at the anti-tumor activity of HBM1020.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic/unresectable RCC, CRC will receive the MTD and/or RP2D established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.

Official Title
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A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: HBM1020


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness to sign a written informed consent document. Male or female subject aged ≥18 years old at the time of screening. Histologically or cytologically confirmed advanced solid tumors or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists. Adequate organ and bone marrow function. Exclusion Criteria: Prior used anti-B7H7 monoclonal antibodies (mAb) or anti-KIR3DL3 monoclonal antibodies (mAb). Any systemic anti-cancer therapy within 4 weeks prior to first dose of investigational medicinal product (IMP), or immunosuppressive medications within 2 weeks before the first dose of investigational medicinal product (IMP). Not yet recovered from surgery or (immune-related) toxicity related with previous treatment. With clinically significant congenital or acquired cardiovascular diseases. With severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, autoimmune disease and human immunodeficiency virus. Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug. Previously untreated brain metastases. Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBM1020<br>HBM1020 is a recombinant fully human anti-B7H7 monoclonal antibody | Drug: HBM1020<br>* Intravenous (IV) Administrations on Days 1 of each 21-day treatment cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with dose-limiting toxicity (DLT) | Number of subjects who experience dose-limiting toxicity (DLT) events during 21 days | From Day 1 until disease progression or Day 21, whichever comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (including vital signs, physical examinations, and abnormal laboratory parameters). | From the date of informed consent until safety follow-up Day 90. | 
| Objective response rate (ORR) | The proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 | Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first. | 
| Duration of response | The time interval from first occurrence of a documented objective response to the time of disease progression as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first | Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first. | 
| Disease control rate | The proportion of subjects with a best overall response of CR, PR, or stable disease (SD) | Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first. | 
| Duration of disease control | The time from the date of start of treatment to the date of disease progression or death for subjects who had CR or PR or SD during treatment | Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first | 
| Tumor shrinkage (The percentage of patients with tumor shrinkage) | The greatest tumor shrinkage achieved at any follow-up assessment. Measured by radiological (computed tomography [CT]/Magnetic Resonance Imaging [MRI]) scanning until documented radiographic disease progression according to RECIST 1.1, or loss of clinical benefit after disease progression according to RECIST 1.1 | Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first. | 
| Maximum serum concentration (Cmax) | Maximum serum concentration | Up to 90 days after end of treatment. | 
| Time to reach maximum serum concentration (Tmax) | Time to reach maximum serum concentration | Up to 90 days after end of treatment. | 
| Area under the serum concentration versus time curve from time zero to the dosing interval tau (AUC0-tau) | area under the serum concentration versus time curve from time zero to the dosing interval tau | Up to 90 days after end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumors