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

NCT05824663 | Completed Phase 1 FDA Drug

• 1 other identifier: 1020.1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Adverse events (AEs)

  From the date of informed consent until safety follow-up Day 90.

• Objective response rate (ORR)

  Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.

• Duration of response

  Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.

• Disease control rate

  Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.

• Duration of disease control

  Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first

Study Arms (1)

HBM1020

EXPERIMENTAL

HBM1020 is a recombinant fully human anti-B7H7 monoclonal antibody

Drug: HBM1020

Interventions

HBM1020 DRUG

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

HBM1020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbour BioMed US, Inc.: lead

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 21, 2023
• Study Start: May 23, 2023
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)