A Study Evaluating the Safety, Tolerance and Anti-tumor A... | NCT05824663

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

NCT05824663

Sponsor

Harbour BioMed US, Inc.

Status

Completed

Last Update Posted

May 4, 2026Actual

Enrollment

17Actual

Phase

Phase 1

Conditions

Advanced Solid Tumor

Interventions

HBM1020

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2023Actual

Primary Completion Date

Oct 9, 2024Actual

Completion Date

Oct 9, 2024Actual

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Apr 10, 2023

First Posted Date

Apr 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Label	Type	Description	Intervention Names
HBM1020	Experimental	HBM1020 is a recombinant fully human anti-B7H7 monoclonal antibody	Drug: HBM1020

Name	Type	Description	Arm Group Labels	Other Names
HBM1020	Drug	Intravenous (IV) Administrations on Days 1 of each 21-day treatment cycle.	HBM1020

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided