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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: QLS12004

• Registration Number: NCT05829616
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

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.The frequency of administration and the dose to be administered in subsequent clinical studies will be determined based on a combination of preliminary data.

Study Timeline

• Study First Submitted: 2023-03-23
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study Start: 2023-04-17
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
2. Age ≥ 18 years when ICF is signed;
3. At least one target lesion as defined per RECIST Version (v) 1.1;
4. 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;
5. Dose escalation phase: HR+/HER2-advanced breast cancer that has failed prior CDK4/6 inhibitor combined with endocrine therapy;
6. Eastern Cooperative Oncology Group performance status of 0 or 1;
7. Adequate hematologic and organ function;
8. Female subjects who are not pregnant or breastfeeding
9. 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.

Exclusion Criteria

1. Subjects with major cardiovascular and cerebrovascular diseases;
2. 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;
3. 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;
4. Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
5. HIV-positive or syphilis spiral antibody-positive persons;
6. 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;
7. Known hypersensitivity to the test drug or any of its excipients;
8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QLS12004	QLS12004	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.

Primary Outcome Measures

Name	Time	Method
AEs, TEAEs, TRAEs, SAEs	up to 2 years	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)
DLT	Up to 21 days after the first dose	Dose-limiting toxicity
MTD	Up to 21 days after the first dose	maximum tolerated dose
RP2D	Up to 21 days after the first dose	recommended phase II dose

Secondary Outcome Measures

Name	Time	Method
Tmax	up to 2 years	Time to Reach Maximum (peak) Plasma Concentration Following Drug Administration
OS	up to 2 years	Objective Response Rate
DCR	up to 2 years	Disease Control Rate
Cmax	up to 2 years	Maximum Plasma Drug Concentration
ORR	up to 2 years	Objective Response Rate
PFS	up to 2 years	Progression-free Survival

Trial Locations

Locations (1)

The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China