Advanced Solid TumorPhase 1NCT06872580
A Study of QLS1209 in theTreatment of Patients With Advanced Solid Tumors
A Phase 1 study testing QLS1209 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The goal of this clinical trial is to assess the safety and tolerability of QLS1209 alone in patients with eligible advanced solid tumors，determine the maximum tolerated dose (MTD) or maximum drug dose（MAD）of QLS1209, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary… 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?
- QLS1209
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Expected survival ≥ 3 months;
- advanced malignant solid tumors who have failed standard treatment or have received no standard treatment；
- a) CCNE1 amplification determined by tumor or plasma next generation sequencing (NGS) or fluorescence in-situ hybridization (FISH); b) FBXW7 mutation determined by tumor or plasma NGS; c) PPP2R1A mutation determined by tumor or plasma NGS;
- Subjects with at least one evaluable tumor lesion (dose-escalation stage) or at least one measurable tumor lesion (dose-expansion stage) according to RECIST v1.1;
Who cannot join
- Previous treatment with PKMYT1 inhibitors;
- Received chemotherapy, biological therapy, endocrine therapy, immunotherapy, monoclonal antibody and other anti-tumor therapies within 4 weeks before the first dose of the investigational drug, special conditions are as follows:
- Including subjects who received oral fluorouracils, small molecule targeted drugs, radiotherapy or traditional Chinese medicines with anti-tumor indications within 2 weeks before the first dose;
- Including subjects who received treatment with mitomycin or nitrosoureas within 6 weeks before the first dose;
- Including subjects who received cell-based therapy or anti-tumor vaccines within 8 weeks before the first dose.
- Presence of uncontrolled or symptomatic central nervous system (CNS) metastases, or presence of leptomeningeal metastases or spinal cord compression due to metastases before signing the ICF. Exceptions: Subjects with symptomatic CNS metastases who have been treated and radiologically stable (defined as 2 brain images of the same imaging modalities, both acquired after treatment for brain metastases with an interval of at least 4 weeks, showing no intracranial progression by comparison) for ≥ 4 weeks before the first dose of the investigational drug, and have discontinued systemic sex hormone (any dose) therapy for > 2 weeks;
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- Subjects with uncontrollable exudate or transudate (thoracic cavity, pericardium and abdominal cavity);
- Subjects with other active malignant tumors within 3 years before being included in the study (from the time of signing ICF), except for the following: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ and other malignant tumors that have been treated without disease evidence within > 2 years and do not require continuous treatment; Known to be allergic to the investigational drug or any of its excipient;
- Subjects with current interstitial lung disease, pneumoconiosis, radiation pneumonitis, severely impaired lung function, etc. that may interfere with the monitoring and treatment of suspected drug-related pulmonary toxicity as judged by the investigator;
- Subjects who are unable to swallow and retain oral drugs, or have active gastrointestinal diseases (including inflammatory bowel disease and intestinal obstruction) and other conditions that seriously affect drug absorption as judged by the investigator;
- Subjects who have other serious physical or psychiatric diseases or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the results of the study, and are considered unsuitable for participation in the study by the investigator;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 QLS1209 in Patients With Advanced Solid Tumors
The goal of this clinical trial is to assess the safety and tolerability of QLS1209 alone in patients with eligible advanced solid tumors，determine the maximum tolerated dose (MTD) or maximum drug dose（MAD）of QLS1209, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
- Conditions
- Advanced Solid Tumor
- Being tested
- QLS1209
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS1209Drug
Levels of QLS1209 will be explored in dose escalation, and determine the maximum tolerated dose.
QLS1209Drug
Every 21 days is one cycle.1-3 dose levels of QLS1209 will be explored in dose optimization, and determine the recommended dose (RD) of QLS1209 and evaluate the preliminary anti-tumor activity of QLS1209.
| Study group | Role | What they receive |
|---|---|---|
| QLS1209 mono dose escalation and optimization | Experimental | Not described Receives: Drug: QLS1209 |
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
MTD/MAD
maximum tolerated dose/ maximum drug 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 (7)
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
DoR
Duration of Response
Measured: up to 2 years
DCR
Disease Control Rate
Measured: up to 2 years
PFS
Progression-free Survival
Measured: up to 2 years
OS
Overall Survival
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 posted12 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (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
- 149 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
- NCT06872580
- Sponsor's protocol ID
- QLS1209-101
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. 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 QLS1209 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06872580
- Acronym / sponsor ID
- QLS1209-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 12 Mar 2025 (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.
The goal of this clinical trial is to assess the safety and tolerability of QLS1209 alone in patients with eligible advanced solid tumors，determine the maximum tolerated dose (MTD) or maximum drug dose（MAD）of QLS1209, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS1209 mono dose escalation and optimization | Experimental | Drug: QLS1209 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Expected survival ≥ 3 months;
- advanced malignant solid tumors who have failed standard treatment or have received no standard treatment；
Key exclusion criteria (11 listed)
- Previous treatment with PKMYT1 inhibitors;
- Received chemotherapy, biological therapy, endocrine therapy, immunotherapy, monoclonal antibody and other anti-tumor therapies within 4 weeks before the first dose of the investigational drug, special conditions are as follows:
- Presence of uncontrolled or symptomatic central nervous system (CNS) metastases, or presence of leptomeningeal metastases or spinal cord compression due to metastases before signing the ICF. Exceptions: Subjects with symptomatic CNS metastases who have been treated and radiologically stable (defined as 2 brain images of the same imaging modalities, both acquired after treatment for brain metastases with an interval of at least 4 weeks, showing no intracranial progression by comparison) for ≥ 4 weeks before the first dose of the investigational drug, and have discontinued systemic sex hormone (any dose) therapy for > 2 weeks;
- Subjects with uncontrollable exudate or transudate (thoracic cavity, pericardium and abdominal cavity);
- Subjects with other active malignant tumors within 3 years before being included in the study (from the time of signing ICF), except for the following: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ and other malignant tumors that have been treated without disease evidence within > 2 years and do not require continuous treatment; Known to be allergic to the investigational drug or any of its excipient;
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 |
|---|---|---|
| QLS1209Levels of QLS1209 will be explored in dose escalation, and determine the maximum tolerated dose. | Drug | QLS1209 mono dose escalation and optimization |
| QLS1209Every 21 days is one cycle.1-3 dose levels of QLS1209 will be explored in dose optimization, and determine the recommended dose (RD) of QLS1209 and evaluate the preliminary anti-tumor activity of QLS1209. | Drug | QLS1209 mono dose escalation and optimization |
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)
MTD/MAD
Time frame: Up to 21 days after the first dose
maximum tolerated dose/ maximum drug dose
RP2D
Time frame: Up to 21 days after the first dose
recommended phase II dose
7 secondary outcomes
Tmax
Time frame: up to 2 years
Cmax
Time frame: up to 2 years
ORR
Time frame: up to 2 years
DoR
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS1209 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd..
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Wu, PhD (021-64175590-88503, JJYIN555@163.com), 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 3 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 12 Mar 2025.