Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma

Sponsor
GeneScience Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05221385
Collaborator
(none)
58
2
1
37.6
29
0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of gentulizumab, an anti-CD47 Monoclonal Antibody, in participants with solid tumors and non-Hodgkin lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is a first-in-human, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ia, Open-label, Dose Escalation Study of Safety, Tolerability, Pharmacokinetics of Gentulizumab, an Anti-CD47 Monoclonal Antibody, in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma (NHL)
Actual Study Start Date :
Apr 12, 2021
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental cohort

Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week.

Drug: Gentulizumab
Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle.

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability of Gentulizumab as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs). [28 days]

    The CTCAE criteria will be used to assess adverse events on this trial.

  2. Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC). [From the first dosing to 90 days after the last dosing]

  3. Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax). [From the first dosing to 90 days after the last dosing]

  4. Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2). [From the first dosing to 90 days after the last dosing]

Secondary Outcome Measures

  1. Pharmacodynamic (PD) Characteristics of Gentulizumab. [From the first dosing to 90 days after the last dosing]

    PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood.

  2. Immunogenicity of Gentulizumab. [From the first dosing to 28 days after the last dosing]

    Numbers of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) positive participants will be used to assess the immunogenicity of gentulizumab.

Other Outcome Measures

  1. Objective Response Rate (ORR) of Gentulizumab as Monotherapy. [From date of first dosing until the date of disease progression or death due to any cause, whichever came first, assessed up to 12 months.]

    ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.

  2. Progression-free Survival (PFS) of Gentulizumab as Monotherapy. [From date of first dosing until the date of disease progression or death due to any cause, whichever came first, assessed up to 12 months.]

    PFS was defined as the time ranging from the beginning of enrollment to the tumor progression for the first time or death.

  3. Exploratory indicators related to biomarkers [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The patient has the willingness to communicate with the investigator, can understand and follow the trial requirements, is willing to participate in the trial, understands and signs a written Informed Consent Form(ICF), and is willing and able to comply with the visit schedule, administration plan, laboratory examination, and other clinical trial procedures.

  • Gender: Male or female.

  • Age 18-70 years old.

  • Expected survival ≥ 12 weeks.

  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

  • Patients with advanced solid tumors or NHL by histopathological diagnosis do not have acceptable standard treatment currently.

  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:
  • Use of protocol-defined prior/concomitant therapy.

  • Currently receiving or has received an investigational treatment as part of a study within 4 weeks before the first dosing.

  • History of severe hypersensitivity reaction to study treatments or their excipients.

  • Known active central nervous system metastases.

  • History of any active autoimmune disease history, or disease or syndrome requiring treatment with systemic steroids or immunosuppressive medications.

  • Presence of active infection.

  • Known additional malignancy that has not been cured in the last 5 years.

  • Any uncontrolled intercurrent illness or condition that in the judgment of the Investigator may endanger the patient.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jian Zhang Shanghai Shanghai China 20032
2 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022

Sponsors and Collaborators

  • GeneScience Pharmaceuticals Co., Ltd.

Investigators

  • Principal Investigator: Jian Zhang, Doctor, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05221385
Other Study ID Numbers:
  • Gensci059-Ia-A
First Posted:
Feb 3, 2022
Last Update Posted:
Feb 3, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2022