Advanced Malignant NeoplasmPhase 1/2NCT06394713
A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors
A Phase 1/2 study testing QLF31907, Irinotecan and Docetaxel in people with Advanced Malignant Neoplasm, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm
- What is being tested?
- QLF31907, Irinotecan and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Dec 2026
- Phase
- Phase 1/2
- 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
- subjects voluntarily participated and signed a written informed consent form;
- age ≥18 years, male or female;
- ECOG PS 0-1;
- histopathologically diagnosed advanced malignant tumors;
- at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
- adequate organ function;
Who cannot join
- previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
- received anti-tumor therapy within 4 weeks prior to the first study treatment;
- history of autoimmune disease;
- history of other active malignancies within 3 years prior to the first treatment;
- history of serous cardiovascular events;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1b/2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1/4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors
This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
- Conditions
- Advanced Malignant Neoplasm
- Being tested
- QLF31907, Irinotecan, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLF31907Drug
intravenous administration, once every 3 weeks
IrinotecanDrug
intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks
DocetaxelDrug
intravenous administration, 75mg/m2, d1, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| QLF31907 in combination with Irinotecan | Experimental | Not described Receives: Drug: QLF31907; Drug: Irinotecan |
| QLF31907 in combination with Docetaxel | Experimental | Not described Receives: Drug: QLF31907; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase Ib: Dose-limiting toxicity(DLT)
The DLT of QLF31907 combination therapy will be determined
Measured: 28 days
phase2: objective response rate(ORR)
the ORR of QLF31907 combinaton therapy will be determined
Measured: up to 2 years
Secondary outcomes (5)
adverse events (AEs) of QLF31907 combination therapy
to evaluate the severity, incidence and causality of adverse events (AEs)
Measured: up to 2 years
area under the concentration-time curve (AUC) of QLF31907
the area under the concentration-time curve (AUC) of QLF31907 will be determined
Measured: up to 2 years
Immunogenicity of QLF31907
the anti-drug antibody(ADA) against QLF31907 will be determined
Measured: up to 2 years
overall survival(OS)
the OS of QLF31907 combination therapy will be determined
Measured: up to 2 years
maximum plasma concentration (Cmax) of QLF31907
the maximum plasma concentration (Cmax) of QLF31907 will be determined
Measured: up to 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 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06394713
- Sponsor's protocol ID
- QLF31907-202
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 1 May 2024
- 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1/4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06394713
- Acronym / sponsor ID
- QLF31907-202
- Conditions
- Advanced Malignant Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 1 May 2024 (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 designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLF31907 in combination with Irinotecan | Experimental | Drug: QLF31907, Drug: Irinotecan |
| QLF31907 in combination with Docetaxel | Experimental | Drug: QLF31907, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjects voluntarily participated and signed a written informed consent form;
- age ≥18 years, male or female;
- ECOG PS 0-1;
- histopathologically diagnosed advanced malignant tumors;
- at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
Key exclusion criteria (5 listed)
- previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
- received anti-tumor therapy within 4 weeks prior to the first study treatment;
- history of autoimmune disease;
- history of other active malignancies within 3 years prior to the first treatment;
- history of serous cardiovascular events;
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 |
|---|---|---|
| QLF31907intravenous administration, once every 3 weeks | Drug | QLF31907 in combination with Docetaxel, QLF31907 in combination with Irinotecan |
| Irinotecanintravenous administration, 125 mg/m2, d1 and d8, every 3 weeks | Drug | QLF31907 in combination with Irinotecan |
| Docetaxelintravenous administration, 75mg/m2, d1, every 3 weeks | Drug | QLF31907 in combination with Docetaxel |
Primary outcome
phase Ib: Dose-limiting toxicity(DLT)
Time frame: 28 days
The DLT of QLF31907 combination therapy will be determined
phase2: objective response rate(ORR)
Time frame: up to 2 years
the ORR of QLF31907 combinaton therapy will be determined
5 secondary outcomes
adverse events (AEs) of QLF31907 combination therapy
Time frame: up to 2 years
area under the concentration-time curve (AUC) of QLF31907
Time frame: up to 2 years
Immunogenicity of QLF31907
Time frame: up to 2 years
overall survival(OS)
Time frame: up to 2 years
maximum plasma concentration (Cmax) of QLF31907
Time frame: up to 2 years
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 1 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QLF31907, Irinotecan and Docetaxel in people with Advanced Malignant Neoplasm, run by Qilu Pharmaceutical Co., Ltd..
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 5 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: opening soon, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lin Shen (010-88196561, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase Ib: Dose-limiting toxicity(DLT) (time frame: 28 days). 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 1 May 2024.