A Study of QL1706H in Patients With Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: QL1706H

• Registration Number: NCT06047431
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-03
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Study Start: 2023-10
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
QL1706H	QL1706H	Part 1 (Dose escalation): QL1706H will be administered in sequential cohorts each receiving 1 dose of QL1706H by subcutaneous injection on day 1 and QL1706 by IV infusion on day 22, from then on will recieve QL1706 on day 1 of every 21-day cycle (3 weeks). Dose escalation will continue until the projected cohorts has been finished. Part 2 (Dose Exploration): The PK parameters of QL1706H will be tested at different administration intervals.

Primary Outcome Measures

Name	Time	Method
Minimum Serum Drug Concentration ( Ctrough)	one cycle (3 weeks)	The minimum serum drug concentration and area under serum concentration-time curve after single administration of QL1706H.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	one cycle (3 weeks)	Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.