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

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Initial Antitumor Activity of QLS12004 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05829616
• Other study ID #: QLS12004-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 17, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: April 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Zefei Jiang, Professor
• Phone: 010-66947797
• Email: jiangzefei[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	DLT	Dose-limiting toxicity	Up to 21 days after the first dose
Primary	MTD	maximum tolerated dose	Up to 21 days after the first dose
Primary	RP2D	recommended phase II dose	Up to 21 days after the first dose
Secondary	Tmax	Time to Reach Maximum (peak) Plasma Concentration Following Drug Administration	up to 2 years
Secondary	Cmax	Maximum Plasma Drug Concentration	up to 2 years
Secondary	ORR	Objective Response Rate	up to 2 years
Secondary	DCR	Disease Control Rate	up to 2 years
Secondary	PFS	Progression-free Survival	up to 2 years
Secondary	OS	Objective Response Rate	up to 2 years