Advanced Solid TumorPhase 1NCT05829616
A Phase I Study of QLS12004 in Patients With Advanced Solid Tumors
A Phase 1 study testing QLS12004 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- QLS12004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 30 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, 100039
Zefei Jiang, Professor, 010-66947797, jiangzefei@csco.org.cn
About this study
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
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.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- QLS12004
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS12004Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: QLS12004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 2 years
DLT
Dose-limiting toxicity
Measured: Up to 21 days after the first dose
MTD
maximum tolerated dose
Measured: Up to 21 days after the first dose
RP2D
recommended phase II dose
Measured: Up to 21 days after the first dose
Secondary outcomes (6)
Tmax
Time to Reach Maximum (peak) Plasma Concentration Following Drug Administration
Measured: up to 2 years
Cmax
Maximum Plasma Drug Concentration
Measured: up to 2 years
ORR
Objective Response Rate
Measured: up to 2 years
DCR
Disease Control Rate
Measured: up to 2 years
PFS
Progression-free Survival
Measured: up to 2 years
OS
Objective Response Rate
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start17 Apr 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829616
- Sponsor's protocol ID
- QLS12004-101
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05829616
- Acronym / sponsor ID
- QLS12004-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS12004 | Experimental | Drug: QLS12004Subjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS12004Subjects 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 |
Primary outcome
AEs, TEAEs, TRAEs, SAEs
Time frame: 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
Time frame: Up to 21 days after the first dose
Dose-limiting toxicity
MTD
Time frame: Up to 21 days after the first dose
maximum tolerated dose
RP2D
Time frame: Up to 21 days after the first dose
recommended phase II dose
6 secondary outcomes
Tmax
Time frame: up to 2 years
Cmax
Time frame: up to 2 years
ORR
Time frame: up to 2 years
DCR
Time frame: up to 2 years
PFS
Time frame: up to 2 years
OS
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS12004 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zefei Jiang, Professor (010-66947797, jiangzefei@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs, TEAEs, TRAEs, SAEs (time frame: up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.