Advanced Solid TumorsPhase 1NCT05278832
A Study of QLS31905 in Patients With Advanced Solid Tumors
A Phase 1 study testing QLS31905 in people with Advanced Solid Tumors, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- QLS31905
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2021to 31 Dec 2023
- 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
- Written informed consent.
- ≥18 years.
- Female or male.
- ECOG performance status score 0 or 1.
- Histologically or cytologically confirmed diagnosis of advanced solid tumors.
- Adequate haematological, hepatic and renal function.
Who cannot join
- Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.
- Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- Patients with a history of monoclonal antibody allergic reaction.
- Known human immunodeficiency virus infection or known symptomatic hepatitis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, 010-881965671, linshenpku@163.com
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of QLS31905 in Patients With Claudin18.2-positive Advanced Solid Tumors
This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.
- Conditions
- Advanced Solid Tumors
- Being tested
- QLS31905
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS31905Drug
QLS31905 injection
| Study group | Role | What they receive |
|---|---|---|
| QLS31905 | Experimental | QLS31905 injection Receives: Drug: QLS31905 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities(DLTs)
Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905
Measured: 2 years
Maximum tolerated Dose(MTD)
To evaluate the safety and tolerability of QLS31905
Measured: 2 years
Secondary outcomes (6)
Progression-free Survival (PFS)
Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
Measured: 2 years
Objective response rate (ORR)
Objective Response Rate (ORR) is the percentage of CR+PR
Measured: 2 years
Disease control rate (DCR)
Disease control Rate (DCR) is the percentage of CR+PR+SD
Measured: 2 years
adverse events (AE)
To evaluate the safety and tolerability of QLS31905
Measured: 2 years
Cmax
Maximum concentration (Cmax) of the drug after administration
Measured: 2 years
AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start25 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 104 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
- NCT05278832
- Sponsor's protocol ID
- QLS31905-101
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of QLS31905 in Patients With Claudin18.2-positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05278832
- Acronym / sponsor ID
- QLS31905-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Mar 2022 (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 is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS31905 | Experimental | Drug: QLS31905QLS31905 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent.
- ≥18 years.
- Female or male.
- ECOG performance status score 0 or 1.
- Histologically or cytologically confirmed diagnosis of advanced solid tumors.
Key exclusion criteria (4 listed)
- Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.
- Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- Patients with a history of monoclonal antibody allergic reaction.
- Known human immunodeficiency virus infection or known symptomatic hepatitis.
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 |
|---|---|---|
| QLS31905QLS31905 injection | Drug | QLS31905 |
Primary outcome
Dose limiting toxicities(DLTs)
Time frame: 2 years
Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905
Maximum tolerated Dose(MTD)
Time frame: 2 years
To evaluate the safety and tolerability of QLS31905
6 secondary outcomes
Progression-free Survival (PFS)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
adverse events (AE)
Time frame: 2 years
Cmax
Time frame: 2 years
AUC
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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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 QLS31905 in people with Advanced Solid Tumors, 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 4 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 14 Mar 2022. 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?
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 limiting toxicities(DLTs) (time frame: 2 years). The study lists 2 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 14 Mar 2022.