Advanced Malignant TumorPhase 1NCT06823609
Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors
A Phase 1 study testing QLS1304 tablet in people with Advanced Malignant Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumor
- What is being tested?
- QLS1304 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2025to Dec 2027
- 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 study, sign an informed consent form and have good compliance;
- Age ≥ 18 years old, Male or female
- ECOG score: 0-1
- Expected survival ≥ 12 weeks
- Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology;
- Failed to standard treatment or has no standard treatment scheme;
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- Baseline presence of at least one evaluable lesion according to the RECIST v1.1;
- The functional level of important organs is basically normal, meeting the requirements of the scheme
- Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
- Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
- Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent
Who cannot join
- 1. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
- Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
- Subjects require long-term or high-dose use of non-steroidal drugs.
- Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
- Subjects have a known or suspected severe allergy to theinvestigational drug or any of its components Subjects have other active malignant tumors within 5 years before the first use of the investigational drug.
- Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease.
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- Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.
- Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.
- Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.
- Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai
Jian Zhang, 021-34778299, syner2000@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors
This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.
- Conditions
- Advanced Malignant Tumor
- Being tested
- QLS1304 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS1304 tabletDrug
QLS1304 monotherapy dose escalation and expansion
| Study group | Role | What they receive |
|---|---|---|
| QLS1304 tablet | Experimental | Not described Receives: Drug: QLS1304 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity (DLT) of QLS1304
Measured: up to 35 days
Maximum tolerated dose（MTD）of QLS1304
Measured: up to 35 days
Recommended Phase II Dose (RP2D) of QLS1304
Measured: up to 35 days
Secondary outcomes (10)
adverse event
Measured: from the first drug administration to within 30 days for the last treatment dose
Cmax
Measured: through study completion, an average of 2 year
objective response rate(ORR)
Measured: through study completion, assessed up to 24 months
Tmax
Measured: through study completion, an average of 2 year
AUC0-t
Measured: through study completion, an average of 2 year
AUC0-inf
Measured: through study completion, an average of 2 year
CL/F
Measured: through study completion, an average of 2 year
Vd/F
Measured: through study completion, an average of 2 year
MRT
Measured: through study completion, an average of 2 year
t1/2
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start6 Mar 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- 180 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
- NCT06823609
- Sponsor's protocol ID
- QLS1304-101
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 13 Jan 2026
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06823609
- Acronym / sponsor ID
- QLS1304-101
- Conditions
- Advanced Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Feb 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.
This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS1304 tablet | Experimental | Drug: QLS1304 tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Volunteer to participate in this study, sign an informed consent form and have good compliance;
- Age ≥ 18 years old, Male or female
- ECOG score: 0-1
- Expected survival ≥ 12 weeks
- Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology;
Key exclusion criteria (10 listed)
- 1. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
- Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
- Subjects require long-term or high-dose use of non-steroidal drugs.
- Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
- Subjects have a known or suspected severe allergy to theinvestigational drug or any of its components Subjects have other active malignant tumors within 5 years before the first use of the investigational drug.
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 |
|---|---|---|
| QLS1304 tabletQLS1304 monotherapy dose escalation and expansion | Drug | QLS1304 tablet |
Primary outcome
Dose limited toxicity (DLT) of QLS1304
Time frame: up to 35 days
Maximum tolerated dose（MTD）of QLS1304
Time frame: up to 35 days
Recommended Phase II Dose (RP2D) of QLS1304
Time frame: up to 35 days
10 secondary outcomes
adverse event
Time frame: from the first drug administration to within 30 days for the last treatment dose
Cmax
Time frame: through study completion, an average of 2 year
objective response rate(ORR)
Time frame: through study completion, assessed up to 24 months
Tmax
Time frame: through study completion, an average of 2 year
AUC0-t
Time frame: through study completion, an average of 2 year
AUC0-inf
Time frame: through study completion, an average of 2 year
CL/F
Time frame: through study completion, an average of 2 year
Vd/F
Time frame: through study completion, an average of 2 year
MRT
Time frame: through study completion, an average of 2 year
t1/2
Time frame: through study completion, an average of 2 year
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 13 Jan 2026.
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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.
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 QLS1304 tablet in people with Advanced Malignant 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) of QLS1304 (time frame: up to 35 days). 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 13 Jan 2026.