A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody

NCT04866485 | Unknown Phase 1

• 1 other identifier: 4003.3
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1a dose confirmation and Part 1b dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with pembrolizumab in patients with advanced NSCLC and other solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Part 1a: Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration

  DLT observation period was defined as one treatment cycles with a total of 21 days

  approximate 21 days

• Part 1b: ORR

  Proportion of subjects with complete response (CR) and partial response (PR)

  maximum 2 years

Secondary Outcomes (20)

• Part 1a: ORR

  maximum 2 years

• Part 1a: Disease Control Rate, DCR

  maximum 2 years

• Part 1a: Duration of Response, DOR

  maximum 2 years

• Part 1a: Duration of Disease Control, DDC

  maximum 2 years

• Cmax

  maximum 2 years

Study Arms (1)

HBM4003+pembrolizumab

EXPERIMENTAL

HBM4003 combined with pembrolizumab in subjects with advanced NSCLC and other solid tumors

Drug: HBM4003 and pembrolizumab

Interventions

HBM4003 and pembrolizumab DRUG

Subjects will be treated with HBM4003 and pembrolizumab on Day 1 during each 21-day cycles.

Also known as: HBM4003

HBM4003+pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥18 years old at the time of signing the informed consent and ≤ 75 years old at the time of enrollment.
• Patients for Part 1a: patients diagnosed with advanced or recurrent solid tumors.
• Patients for Part 1b: patients diagnosed with metastatic NSCLC and confirmed with negative tumor PD-L1 expression (TPS\<1%).
• Patients for Part 1b dose expansion study: have never received systemic therapies as primary therapy for advanced or metastatic diseases.
• Patients must be able to provide fresh tumor tissues or archived tumor tissues.
• Patients whose estimated survival time is more than 3 months.
• Patients with at least one measurable lesion at baseline according to RECIST (version 1.1).
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
• Patients whose organ function must meet the study requirements.
• Males or females with childbearing potential need to use an effective contraceptive method.
• Willing and able to comply with study-specified visits schedule, treatment plan, laboratory examination and other study procedures.

You may not qualify if:

• NSCLC patients with EGFR-sensitive mutations or an ALK translocation based on diagnosis results.
• Patients who are simultaneously participating in another clinical study, unless the study is an observational (non-interventional) clinical study or the patient is already in the survival follow-up period of the interventional study.
• Patients with a medical history of severe allergic diseases, a history of severe drug allergies, and are known or suspected allergy to macromolecular protein preparations or HBM4003 or pembrolizumab excipients.
• Previous and concomitant drugs or treatments to be excluded like CTLA4, PD-1,PD-L1.
• Insufficient completely recovery from previous treatments.
• Diseases that may affect the efficacy and safety of the investigational product.
• A history of other malignant diseases within 5 years before the first dose.
• Active brain metastasis or leptomeningeal metastasis during screening or previous with imaging evidence (based on CT or MRI assessment).
• Patients who have received palliative radiotherapy for non-central nervous system lesions within 2 weeks before the first dose.
• Patients who have received more than 30 Gy of lung radiation therapy within 6 months before the first dose.
• A history of interstitial lung disease or non-infectious pneumonia.
• Patients with pleural effusion, pericardial effusion, or ascites.
• Patients that may have other conditions that affect the efficacy or safety evaluation of this study (such as mental disorder, alcoholism, drug abuse, etc.) .
• Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and within 3 months after the last dose of study drug.

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Shun LU, Doctor

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi LIU

CONTACT

+8618616529165; hbm4003public@harbourbiomed.com

Peter ZHAO

CONTACT

+8617601647910; hbm4003public@harbourbiomed.com

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: April 26, 2021
• First Posted: April 29, 2021
• Study Start: June 14, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 29, 2021

Record last verified: 2021-04