Advanced Solid TumorPhase 1NCT05884801
Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors
A Phase 1 study testing QLS1103 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 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?
- QLS1103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 30 Jul 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
- 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- 2. Aged ≥18 years old;
- 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;
- 4. Failure of adequate standard treatment, or no effective standard treatment;
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- 6. Life expectancy ≥12 weeks;
Who cannot join
- 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;
- 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;
- 3. Subjects received major surgery within 4 weeks prior to the first dose;
- 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior therapy;
- 5. Cardiovascular and cerebrovascular diseases with clinical significance;
- 6. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510060
Huajun Chen, MD
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors
This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- QLS1103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS1103Drug
Oral dose
| Study group | Role | What they receive |
|---|---|---|
| QLS1103 Dose Escalation and Expansion | Experimental | Not described Receives: Drug: QLS1103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Measured: Up to 24 approximately months
Adverse events(AEs) / Serious adverse events(SAEs)
Measured: Up to 24 approximately months
Secondary outcomes (7)
Maximum observed plasma concentration (Cmax) of QLS1103
Measured: Up to approximately 2 years
Time of maximum observed plasma concentration (Tmax) of QLS1103
Measured: Up to approximately 2 years
Area under the plasma concentration-time curve (AUC) of QLS1103
Measured: Up to approximately 2 years
Objective response rate (ORR)
Measured: Up to approximately 2 years
Disease control rate (DCR)
Measured: Up to approximately 2 years
Duration of response (DOR)
Measured: Up to approximately 2 years
Progression free survival (PFS)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start30 Jun 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jul 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884801
- Sponsor's protocol ID
- QLS1103-101
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 1 Aug 2023
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05884801
- Acronym / sponsor ID
- QLS1103-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 1 Jun 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 phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS1103 Dose Escalation and Expansion | Experimental | Drug: QLS1103 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- 2. Aged ≥18 years old;
- 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;
- 4. Failure of adequate standard treatment, or no effective standard treatment;
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
Key exclusion criteria (6 listed)
- 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;
- 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;
- 3. Subjects received major surgery within 4 weeks prior to the first dose;
- 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior therapy;
- 5. Cardiovascular and cerebrovascular diseases with clinical significance;
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 |
|---|---|---|
| QLS1103Oral dose | Drug | QLS1103 Dose Escalation and Expansion |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Time frame: Up to 24 approximately months
Adverse events(AEs) / Serious adverse events(SAEs)
Time frame: Up to 24 approximately months
7 secondary outcomes
Maximum observed plasma concentration (Cmax) of QLS1103
Time frame: Up to approximately 2 years
Time of maximum observed plasma concentration (Tmax) of QLS1103
Time frame: Up to approximately 2 years
Area under the plasma concentration-time curve (AUC) of QLS1103
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
Yilong Wu, MD principal investigator
Guangdong Provincial People's Hospital
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 QLS1103 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 6 inclusion and 6 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 1 Aug 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 Qing Shao (+8615221936606, qing1.shao@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 21 Days (first cycle)). 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 1 Aug 2023.