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

NCT05221385 | Terminated Phase 1

• 1 other identifier: Gensci059-Ia-A
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor; Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (4)

• 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).

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

  28 days

• Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).

  From the first dosing to 90 days after the last dosing

• Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).

  From the first dosing to 90 days after the last dosing

• Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).

  From the first dosing to 90 days after the last dosing

Secondary Outcomes (2)

• Pharmacodynamic (PD) Characteristics of Gentulizumab.

  From the first dosing to 90 days after the last dosing

• Immunogenicity of Gentulizumab.

  From the first dosing to 28 days after the last dosing

Other Outcomes (3)

• 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.

• 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.

• Exploratory indicators related to biomarkers

  12 months

Study Arms (1)

Experimental cohort

EXPERIMENTAL

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

Drug: Gentulizumab

Interventions

Gentulizumab DRUG

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

Experimental cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Jian Zhang

Shanghai, Shanghai Municipality, 20032, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jian Zhang, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

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: December 27, 2021
• First Posted: February 3, 2022
• Study Start: April 12, 2021
• Primary Completion: May 30, 2023
• Study Completion: October 27, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)