Advanced Solid TumorPhase 1NCT06019013
A Study of QLF3108 in Participants With Advanced Solid Tumor
A Phase 1 study testing QLF3108 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor. 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?
- QLF3108
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2023to Dec 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
- The volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial.
- ≥18 years old and body weight ≥40 kg; Female or male.
- Histologically or cytologically documented advanced solid tumor;
- Failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors.
- Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
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- Adequate hematologic and end organ function.
- Female subjects who are not pregnant or not breastfeeding. A negative blood pregnancy test for females of childbearing potential within 7 days prior to first dosing.
- Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.
Who cannot join
- Patients that have previously received cancer therapy within 4 weeks prior to the first dose of the investigational drug.
- Patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug.
- Active autoimmune disease that has required systemic treatment within 2 years prior to this study.
- A live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug.
- Patients with Adverse Events(AEs) from previous treatment that have not recovered to ≤1(CTCAE 5.0）; or are unstable status.
- Severe concomitant medical condition for bowel obstruction, or implanted colon stent during screening period.
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- Patients with a history of HIV positive or other immunodeficiency. Or patients with the history of organ transplant or allogeneic bone marrow (excluding corneal transplantation).
- Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or alcohol abuse, may impact patient completion of the study.
- Patients may interfere with the interpretation of study results as determined by the investigator, or are unable to participate in the whole study, or deemed unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100000
Xu Jianming, M.D, 13910866712, Jianmingxu2014@163.com
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy Investigate the Immunogenicity and Pharmacokinetic Characteristics of QLF3108 Injection in Patients With Advanced Solid Tumors
This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.
Read the detailed description
This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK) expansion study of QLF3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.
- Conditions
- Advanced Solid Tumor
- Being tested
- QLF3108
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLF3108Drug
QLF3108 will be administered independent of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation Stage and PK-Expansion Stage | Experimental | Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD).
PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial. Receives: Drug: QLF3108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs of QLF3108
dose-limiting toxicity
Measured: Approximately 24 months
MTD(s) of QLF3108
the maximum tolerated dose
Measured: Approximately 24 months
RP2D of QLF3108
a recommended Phase 2 dose
Measured: Approximately 24 months
Secondary outcomes (10)
The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0
The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0
Measured: Approximately 24 month
The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0
The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0
Measured: Approximately 24 month
Cmax of QLF3108
Pharmacokinetics of QLF3108 by assessment of maximum plasma QLF3108 concentration.
Measured: Approximately 24 month
Tmax of QLF3108
Pharmacokinetics of QLF3108 by assessment of time to Cmax
Measured: Approximately 24 month
Area under the plasma concentration-time curve (AUC) of QLF3108
Pharmacokinetics of QLF3108 by assessment of area under the plasma concentration time curve from zero to infinity
Measured: Approximately 24 month
Tl/2 of QLF3108
Pharmacokinetics of QLF3108 by assessment of the terminal half-life
Measured: Approximately 24 month
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Approximately 24 months
Duration of Response (DOR)
DOR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Measured: Approximately 24 months
Progression-free survival (PFS)
PFS defined as the time from baseline to first observed disease progression or death from any cause
Measured: Approximately 24 months
Overall survival time (OS)
Overall survival (OS) is the time between the subject's first infusion QLF3108 injection and death from any cause.
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start16 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 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
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xu Jianming, M.D, Principal investigator, Chinese People's Liberation Army (PLA) General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019013
- Sponsor's protocol ID
- QLF3108-101
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Efficacy Investigate the Immunogenicity and Pharmacokinetic Characteristics of QLF3108 Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06019013
- Acronym / sponsor ID
- QLF3108-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Aug 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 will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.
Detailed description
This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK) expansion study of QLF3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation Stage and PK-Expansion Stage | Experimental | Drug: QLF3108Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD). PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial.
- ≥18 years old and body weight ≥40 kg; Female or male.
- Histologically or cytologically documented advanced solid tumor;
- Failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors.
- Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1.
Key exclusion criteria (9 listed)
- Patients that have previously received cancer therapy within 4 weeks prior to the first dose of the investigational drug.
- Patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug.
- Active autoimmune disease that has required systemic treatment within 2 years prior to this study.
- A live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug.
- Patients with Adverse Events(AEs) from previous treatment that have not recovered to ≤1(CTCAE 5.0）; or are unstable status.
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 |
|---|---|---|
| QLF3108QLF3108 will be administered independent of body weight. | Drug | Dose-Escalation Stage and PK-Expansion Stage |
Primary outcome
DLTs of QLF3108
Time frame: Approximately 24 months
dose-limiting toxicity
MTD(s) of QLF3108
Time frame: Approximately 24 months
the maximum tolerated dose
RP2D of QLF3108
Time frame: Approximately 24 months
a recommended Phase 2 dose
10 secondary outcomes
The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0
Time frame: Approximately 24 month
The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0
Time frame: Approximately 24 month
Cmax of QLF3108
Time frame: Approximately 24 month
Tmax of QLF3108
Time frame: Approximately 24 month
Area under the plasma concentration-time curve (AUC) of QLF3108
Time frame: Approximately 24 month
Tl/2 of QLF3108
Time frame: Approximately 24 month
Overall Response Rate (ORR)
Time frame: Approximately 24 months
Duration of Response (DOR)
Time frame: Approximately 24 months
Progression-free survival (PFS)
Time frame: Approximately 24 months
Overall survival time (OS)
Time frame: Approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
Xu Jianming, M.D principal investigator
Chinese People's Liberation Army (PLA) General 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 QLF3108 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 9 inclusion and 9 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 31 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 Xu Jianming, M.D (13910866712, Jianmingxu2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs of QLF3108 (time frame: Approximately 24 months). 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 31 Aug 2023.