Advanced Solid TumorsPhase 1NCT05823285
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients
A Phase 1 study testing QLS31903 in people with Advanced Solid Tumors, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer. 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?
- QLS31903
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2023to 15 Jun 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
- 18 years or older, 40kg or heavier
- Histologically or cytologically confirmed diagnosis of advanced solid tumor （For phase 1b, patients must have solid tumor with GPC3+ )
- Standard treatment failed or standard treatment intolerant, no standard treatment
- Adequate hepatic, hematologic, and renal function
Who cannot join
- Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions
- Other clinical trial within 4 weeks prior to the first QLS31903 administration
- Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration
- Prior treatment targeted on GPC3
- HBsAg/HBcAb positive and HBV-DNA>10,000 copy/mL;HCV-Ab positive and HCV-RNA>1,000 copy/mL
- CNS metastasis (except asymptomatic brain metastases or symptomatic brain metastases after treatment stable for more than 4 weeks) and/or carcinomatous meningitis or leptomeningeal disease
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 Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Zhenggang Ren, PhD, 8613681971302, ren.zhenggang@zs-hospital.sh.cn
Zhenggang Ren, PhD
About this study
Official title: A Phase 1 Study to Investigate the Safety, Tolerability，Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS31903 Injection in Subjects With Advanced Solid Tumors
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.
- Conditions
- Advanced Solid Tumors
- Being tested
- QLS31903
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS31903Drug
0.01μg/kg-2.16 μg/kg QLS31903 for injection
| Study group | Role | What they receive |
|---|---|---|
| QLS31903 | Experimental | 0.01μg/kg-2.16 μg/kg QLS31903 for injection Receives: Drug: QLS31903 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose（MTD）for Phase 1a
The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached.
Measured: 21days or 14 days after the first target dose(whichever is longer）
Recommended phase 2 dose(RP2D) for Phase 1a
The RP2D is defined as the dose level chosen by Safety Monitoring Committee(SMC)
Measured: Duration of study, approximately 24 months
Objective Response Rate (ORR) for phase 1b
ORR is the percentage of patients with best response of CR and PR
Measured: From fist administration of QLS31903 to disease progression，death，loss to follow up,withdrawal of consent,initiation of a new anticancer therapy,study completion/closure,whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start22 Mar 2023
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2027 (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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoyan Kang, PhD, Study chair, Qilu Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823285
- Sponsor's protocol ID
- QLS31903-101
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Safety, Tolerability，Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS31903 Injection in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05823285
- Acronym / sponsor ID
- QLS31903-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 21 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.
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS31903 | Experimental | Drug: QLS319030.01μg/kg-2.16 μg/kg QLS31903 for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older, 40kg or heavier
- Histologically or cytologically confirmed diagnosis of advanced solid tumor （For phase 1b, patients must have solid tumor with GPC3+ )
- Standard treatment failed or standard treatment intolerant, no standard treatment
- Adequate hepatic, hematologic, and renal function
Key exclusion criteria (6 listed)
- Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions
- Other clinical trial within 4 weeks prior to the first QLS31903 administration
- Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration
- Prior treatment targeted on GPC3
- HBsAg/HBcAb positive and HBV-DNA>10,000 copy/mL;HCV-Ab positive and HCV-RNA>1,000 copy/mL
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 |
|---|---|---|
| QLS319030.01μg/kg-2.16 μg/kg QLS31903 for injection | Drug | QLS31903 |
Primary outcome
Maximum tolerated dose（MTD）for Phase 1a
Time frame: 21days or 14 days after the first target dose(whichever is longer）
The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached.
Recommended phase 2 dose(RP2D) for Phase 1a
Time frame: Duration of study, approximately 24 months
The RP2D is defined as the dose level chosen by Safety Monitoring Committee(SMC)
Objective Response Rate (ORR) for phase 1b
Time frame: From fist administration of QLS31903 to disease progression，death，loss to follow up,withdrawal of consent,initiation of a new anticancer therapy,study completion/closure,whichever came first, assessed up to 24 months
ORR is the percentage of patients with best response of CR and PR
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 21 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Xiaoyan Kang, PhD study chair
Qilu Pharmaceutical Co., Ltd.
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 QLS31903 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 4 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: looking for participants now, as of the sponsor's last update on 21 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?
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 Yan Chen, PhD (8617843558626, yan12.chen@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）for Phase 1a (time frame: 21days or 14 days after the first target dose(whichever is longer）). 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 21 Apr 2023.