A Study of QL1706H in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase Ⅰ Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of QL1706H in Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06047431
• Other study ID #: QL1706H-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Peizhen Wang, bachelor
• Phone: 18001246877
• Email: peizhen.wang[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, Phase Ⅰ study of QL1706H in patients with advanced solid tumors. The study will evaluate the pharmacokenetics, safety, tolerability and preliminary efficacy of QL1706H.

Description:

The study is composed of 2 parts. Part 1 is a dose-escalation study to explore the pharmacokenetics (PK), safety, and tolerability of QL1706H. Part 2 of the study will explore the PK characteristics of differente intervals and sites of administration. All the PK parameters will determine the recommended Phase 2 dose (RP2D).

The study was divided into screening/baseline, treatment and follow-up periods. Safety monitoring will be conducted throughout the study period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects participate voluntarily and sign informed consent.

• Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery

• Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.

• Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.

• The extension of life is more than 3 months

• Vital organs' function is adequate for enrolling

• Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.

• Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to =1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.

Exclusion Criteria:

• Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.

• There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.

• Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.

• Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study

• Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period

• Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor.

• Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs

• Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) >2000 IU/ mL or 10^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• QL1706H
QL1706H is the subcutaneousely administered formulation of QL1706, it contains two unique monoclonal antibodies.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum Serum Drug Concentration ( Ctrough)	The minimum serum drug concentration and area under serum concentration-time curve after single administration of QL1706H.	one cycle (3 weeks)
Secondary	Safety and tolerability	Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.	one cycle (3 weeks)