A Phase I Study of QLS12004 in Patients With Advanced Solid Tumors

NCT05829616 | Unknown Phase 1

• 1 other identifier: QLS12004-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, open, dose-escalation, and dose-expansion phase I clinical trial of QLS12004 in patients with advanced solid tumors, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of QLS12004 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• AEs, TEAEs, TRAEs, SAEs

  Incidence, severity and relevance to the trial drug of adverse events (AEs), treatment-related adverse events (TEAEs), treatment-related adverse events (TRAEs) and serious adverse events (SAEs)

  up to 2 years

• DLT

  Dose-limiting toxicity

  Up to 21 days after the first dose

• MTD

  maximum tolerated dose

  Up to 21 days after the first dose

• RP2D

  recommended phase II dose

  Up to 21 days after the first dose

Secondary Outcomes (6)

• Tmax

  up to 2 years

• Cmax

  up to 2 years

• ORR

  up to 2 years

• DCR

  up to 2 years

• PFS

  up to 2 years

Study Arms (1)

QLS12004

EXPERIMENTAL

Subjects will be treated with different dose groups of QLS12004 according to the frequency and periodicity of administration as specified in the protocol, until disease progression or unacceptable toxicity.

Drug: QLS12004

Interventions

QLS12004 DRUG

Subjects will be treated with different dose groups of QLS12004 according to the frequency and periodicity of administration as specified in the protocol, until disease progression or unacceptable toxicity.

QLS12004

Eligibility Criteria

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

You may qualify if:

• Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
• Age ≥ 18 years when ICF is signed;
• At least one target lesion as defined per RECIST Version (v) 1.1;
• Dose escalation phase: Pts with histologically or cytologically confirmed advanced solid tumors, who have failed standard therapy or for whom no standard therapy is available;
• Dose escalation phase: HR+/HER2-advanced breast cancer that has failed prior CDK4/6 inhibitor combined with endocrine therapy;
• Eastern Cooperative Oncology Group performance status of 0 or 1;
• Adequate hematologic and organ function;
• Female subjects who are not pregnant or breastfeeding
• Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 90 days after last dose.

You may not qualify if:

• Subjects with major cardiovascular and cerebrovascular diseases;
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
• Subjects who have received chemotherapy, endocrine therapy, immunotherapy, and targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
• Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
• HIV-positive or syphilis spiral antibody-positive persons;
• Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose, or the need for elective surgery during the trial;
• Known hypersensitivity to the test drug or any of its excipients;
• History or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army

Beijing, Beijing Municipality, 100039, China

Location

Central Study Contacts

Zefei Jiang, Professor

CONTACT

010-66947797; jiangzefei@csco.org.cn

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: March 23, 2023
• First Posted: April 25, 2023
• Study Start: April 17, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)