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

NCT04954456 | Unknown Phase 1

• 1 other identifier: QLS31901-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability,as defined by the rate of treatment-related events as assessed by NCI CTCAE v5.0.

  21days

Study Arms (1)

QLS31901

EXPERIMENTAL

Part 1 (Dose escalation): QLS31901will be administered in sequential cohorts each receiving 1 of 6 doses of QLS31901 on day 1 of every 21-day cycle (3 weeks) via IV infusion. Dose escalation will continue until an MTD is reached. Part 2 (Dose Expansion): The PK parameters of QLS31901 will be tested at 2-3 doses determined during the dose-escalation phase in subjects with advanced malignant tumor cohorts.

Drug: QLS31901

Interventions

QLS31901 DRUG

QLS31901 is a bispecific antibody specifically targeting PD-L1 and TGF-β.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

QLS31901

Eligibility Criteria

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

You may qualify if:

• Age: 18 to 75 years, male or female.
• Eastern Cooperative Oncology Group (ECOG) score of 0-1.
• Life expectancy ≥ 12 weeks.
• At least one measurable lesion by imaging according to RECIST v1.1 evaluation criteria
• Patients who failed standard treatment or were absent of standard treatment and have a pathologically confirmed advanced malignant tumor.
• Sufficient organ function before the first dose of the investigational product

You may not qualify if:

• Prior anti-cancer immunotherapy(Those who have received PD1 / PDL1 can be included in this study).
• Known allergy to the investigational product or any excipient or severe anaphylaxis to other monoclonal antibodies.
• Received any of the following treatments or drugs prior to the first dose of the study:
• Symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis before signing of the informed consent form.
• Patients with uncontrollable severe exudation (thoracic cavity, pericardium, abdominal cavity);
• 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);

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

RECRUITING

Study Officials

• Jifeng Feng

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

oliver Kong, CMO

CONTACT

0531-83129659; oliver.kong@qilu-pharma.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: June 1, 2021
• First Posted: July 8, 2021
• Study Start: June 2, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-06

Locations

CN (1)