HBM7008 -Study on Subjects With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT05306444
• Recruitment Status: Recruiting
• First Posted: April 1, 2022
• Last Update Posted: September 6, 2022
• Sponsor: Harbour BioMed US, Inc.
• Information provided by (Responsible Party): Harbour BioMed US, Inc.

Study Description

Brief Summary:

Study to evaluate the safety and tolerability of the study drug HBM7008, to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM7008.

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumor	Drug: HBM 7008	Phase 1

Detailed Description:

This is a study to evaluate the safety and tolerability of the study drug HBM7008, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM7008.

The study will also look at the anti-tumor activity of HBM7008.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 Non small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC) will receive the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 108 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Dose escalation (Part 1) followed by Dose expansion (Part 2)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HBM7008 in Subjects With Advanced Solid Tumors
• Actual Study Start Date: May 12, 2022
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: HBM 7008 - Part 1; Experimental Part 1: Dose escalation Intravenous IV administrations of HBM7008 on Days 1 of each 21 day treatment cycle Dose for cohorts to be confirmed following consultation and approval by Safety Review Committee.	Drug: HBM 7008; Intravenous (IV) administration
Experimental: HBM 7008 - Part 2; Experimental Part 2 - Dose Expansion Treatment administered at Maximum Tolerated Dose (MTD) and / or Recommended Phase 2 Dose (RP2D) established in Part 1.	Drug: HBM 7008; Intravenous (IV) administration

Outcome Measures

Primary Outcome Measures :

1. Proportion of subjects with dose-limiting toxicity (DLT) [ Time Frame: From Day 1 until day 21 ]
   Number of subjects who experienced DLT events during 21 days after first administration of HBM7008, divided by the number of DLT evaluable Subjects

Secondary Outcome Measures :

1. Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: From signing of Informed Consent Form (ICF) till 84 days after last dose ]
   Number of participants with Adverse Events (including vital signs, physical examinations, and abnormal laboratory parameters).
2. Objective response rate, defined as the proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 [ Time Frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months ]
   Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECISIT 1.1
3. Duration of response [ Time Frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months ]
   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.
4. Disease control rate [ Time Frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months. ]
   The proportion of subjects with a best overall response of Complete Response (CR), Partial Response (PR), or stable disease (SD).
5. Duration of disease control [ Time Frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months. ]
   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
6. Maximal tumor shrinkage [ Time Frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months ]
   The greatest tumor shrinkage achieved at any follow-up assessment
7. Pharmacokinetics Analysis - Serum Concentration [ Time Frame: Up to 84 days post last dose ]
   Reporting of serum concentration of HBM 7008
8. Anti-drug antibodies [ Time Frame: Up to 84 days post last dose ]
   Measure of detectable Anti-drug antibody (ADA) and neutralizing antibodies in serum samples at specific study timepoints
9. Pharmacokinetics Analysis - Time Deviation [ Time Frame: Up to 84 days post last dose ]
   Reporting time deviation data of HBM 7008

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (e.g., breast cancer, ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-small cell lung cancer (sNSCLC), cholangiocarcinoma, esophagus cancer, urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC)), followed by dose-expansion cohorts (Part 2) of subjects with advanced and/or metastatic non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC).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-B7H4 and/or anti-4-1BB antibody treatment.
2. Immuno-oncology therapy or targeted anti-cancer therapy within 4 weeks prior to first dose of IP, any other anti-cancer therapy within 2 weeks prior to first dose of IP.
3. Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
4. Known history or active infection of hepatitis B or C.
5. History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related, autoimmune hepatitis.
6. Known brain metastases or other central nervous system metastases that are either symptomatic or untreated that require concurrent treatment.
7. Active infection that requires treatment with antibiotics or antiviral treatment within 3 weeks prior to first dose of IP.
8. Known history of infection with human immunodeficiency virus or known acquired immunodeficiency syndrome (AIDS).
9. Known autoimmune disease.
10. Clinically significant cardiac condition.
11. Pregnant or breastfeeding women.

Contacts and Locations

Contacts

Contact: Keesha Steed-Lee; +13025953644; keesha.steed-lee@harbourbiomed.com

Contact: Helen Liu; +8615000477167; helen.liu@harbourbiomed.com

Locations

United States, North Carolina

Carolina BioOncology Institute - Cancer Research Centre; Active, not recruiting

Huntersville, North Carolina, United States, 28078

Australia, New South Wales

St George Private Hospital; Recruiting

Kogarah, New South Wales, Australia, 2217

Contact: Tracy Liaw liawt@ramsayhealth.com.au

Principal Investigator: Kate Wilkinson, MBBS FRACP

Southern Medical Day Care Centre; Recruiting

Wollongong, New South Wales, Australia, 2500

Principal Investigator: Philip Clingan

Sponsors and Collaborators

Harbour BioMed US, Inc.

More Information

• Responsible Party: Harbour BioMed US, Inc.
• ClinicalTrials.gov Identifier: NCT05306444
• Other Study ID Numbers: HBM 7008.1
• First Posted: April 1, 2022
• Last Update Posted: September 6, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Data generated by this study will be considered confidential by the Investigator, except to the extent that it is included in a publication. The general strategy regarding publication of the study will be mutually agreed upon by the Investigator and Sponsor. The Sponsor reserves the right to manage the publication of all study results. The Investigator agrees that oral and written communication to third parties of any procedures or results from the study is subject to prior written consent of the Sponsor. Presentation material and/or manuscript(s) for publication will be reviewed by the Sponsor prior to submission for publication. Alterations in the material will only be made in agreement between the Investigator and the Sponsor

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Harbour BioMed US, Inc.:

Advanced Solid Tumors

Additional relevant MeSH terms:

Neoplasms