A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HBM1020 HBM1020 is a recombinant fully human anti-B7H7 monoclonal antibody |
Drug: HBM1020
Intravenous (IV) Administrations on Days 1 of each 21-day treatment cycle.
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with dose-limiting toxicity (DLT) [From Day 1 until disease progression or Day 21, whichever comes first.]
Number of subjects who experience dose-limiting toxicity (DLT) events during 21 days
Secondary Outcome Measures
- Adverse events (AEs) [From the date of informed consent until safety follow-up Day 90.]
According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (including vital signs, physical examinations, and abnormal laboratory parameters).
- Objective response rate (ORR) [Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.]
The proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1
- Duration of response [Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.]
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
- Disease control rate [Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.]
The proportion of subjects with a best overall response of CR, PR, or stable disease (SD)
- Duration of disease control [Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first]
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
- Tumor shrinkage (The percentage of patients with tumor shrinkage) [Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.]
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
- Maximum serum concentration (Cmax) [Up to 90 days after end of treatment.]
Maximum serum concentration
- Time to reach maximum serum concentration (Tmax) [Up to 90 days after end of treatment.]
Time to reach maximum serum concentration
- Area under the serum concentration versus time curve from time zero to the dosing interval tau (AUC0-tau) [Up to 90 days after end of treatment.]
area under the serum concentration versus time curve from time zero to the dosing interval tau
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willingness to sign a written informed consent document.
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Male or female subject aged ≥18 years old at the time of screening.
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Histologically or cytologically confirmed advanced solid tumors or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.
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Adequate organ and bone marrow function.
Exclusion Criteria:
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Prior used anti-B7H7 monoclonal antibodies (mAb) or anti-KIR3DL3 monoclonal antibodies (mAb).
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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).
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Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
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With clinically significant congenital or acquired cardiovascular diseases.
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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.
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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.
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Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
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Previously untreated brain metastases.
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Pregnant or breastfeeding women.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Harbour BioMed US, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1020.1