A Study of QL1706H in Patients With Advanced Solid Tumors

NCT06047431 | Unknown Phase 1

• 1 other identifier: QL1706H-101
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and tolerability

  one cycle (3 weeks)

Study Arms (1)

QL1706H

EXPERIMENTAL

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.

Drug: QL1706H

Interventions

QL1706H DRUG

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

QL1706H

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Officials

• Wei Lu, Doctor

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peizhen Wang, bachelor

CONTACT

18001246877; peizhen.wang@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share