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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: HBM1020

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Humphrey Gardner, MD; Phone Number: (781)375-6856; Email: Humphrey.Gardner@harbourbiomed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willingness to sign a written informed consent document.
2. Male or female subject aged ≥18 years old at the time of screening.
3. Histologically or cytologically confirmed advanced solid tumors or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.
4. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Prior used anti-B7H7 monoclonal antibodies (mAb) or anti-KIR3DL3 monoclonal antibodies (mAb).
2. 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).
3. Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
4. With clinically significant congenital or acquired cardiovascular diseases.
5. 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.
6. 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.
7. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
8. Previously untreated brain metastases.
9. Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Harbour BioMed US, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Advanced Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 1020.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No