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

NCT ID: NCT05824663

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-06-30

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).

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HBM1020

HBM1020 is a recombinant fully human anti-B7H7 monoclonal antibody

Group Type: EXPERIMENTAL

HBM1020

Intervention Type: DRUG

Intravenous (IV) Administrations on Days 1 of each 21-day treatment cycle.

Interventions

HBM1020

Intravenous (IV) Administrations on Days 1 of each 21-day treatment cycle.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbour BioMed US, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Humphrey Gardner, MD

Role: CONTACT

Humphrey.Gardner@harbourbiomed.com

(781)375-6856

Other Identifiers

1020.1

Identifier Type: -

Identifier Source: org_study_id