A Study of Bispecific Antibody QLS31901 in Patients With Advanced or Metastatic Malignancies

Advanced Malignant Tumor Clinical Trial

Official title:

A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of QLS31901 for Injection in Patients With Advanced Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954456
• Other study ID #: QLS31901-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 2, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2021
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: oliver Kong, CMO
• Phone: 0531-83129659
• Email: oliver.kong[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of QLS31901 in advanced or metastatic malignancies

Description:

Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion.

Part 2 is a dose expansion to confirm the dose of QLS31901 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement.

The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment(first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30days 、60days and 90 days after the last dose) including survival follow-up checks every 3 months up to 12 months after the death of patient or the end of this clinical trial .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18 to 75 years, male or female.

2. Eastern Cooperative Oncology Group (ECOG) score of 0-1.

3. Life expectancy = 12 weeks.

4. At least one measurable lesion by imaging according to RECIST v1.1 evaluation criteria

5. Patients who failed standard treatment or were absent of standard treatment and have a pathologically confirmed advanced malignant tumor.

6. Sufficient organ function before the first dose of the investigational product

Exclusion Criteria:

1. Prior anti-cancer immunotherapy(Those who have received PD1 / PDL1 can be included in this study).

2. Known allergy to the investigational product or any excipient or severe anaphylaxis to other monoclonal antibodies.

3. Received any of the following treatments or drugs prior to the first dose of the study:

4. Symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis before signing of the informed consent form.

5. Patients with uncontrollable severe exudation (thoracic cavity, pericardium, abdominal cavity);

6. Presence of active autoimmune disease or has a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [patients whose condition can be controlled by thyroid hormone replacement therapy can be enrolled]; Subjects suffer from skin diseases that does not require systemic treatment, such as vitiligo, psoriasis, alopecia, type I diabetes, or childhood asthma that has completely alleviated and does not require any adult intervention can be enrolled. Asthmatic patients requiring bronchodilators for medical intervention cannot be enrolled);

Related Conditions & MeSH terms

• Advanced Malignant Tumor
• Neoplasms

Intervention

Drug:
• QLS31901
QLS31901 is a bispecific antibody specifically targeting PD-L1 and TGF-ß.In part 1,the QLS31901 will be administered in sequential cohorts on day 1 of every 21-day cycle (3 weeks) via IV infusion.In part 2,the QLS31901 will be administered in parallel cohorts(selected dose and dosing frequency ) on day 1 of every 2week or every 3week via IV infusion

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Safety and tolerability,as defined by the rate of treatment-related events as assessed by NCI CTCAE v5.0.	21days