Solid TumorPhase 1NCT05150405
A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors
A Phase 1 study testing QLF31907 in people with Solid Tumor and Lymphoma, Non-Hodgkin, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is designed to evaluate the safety and tolerability of QLF31907 injection, to identify the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), and determine the recommended phase Ib dose(RPIbD) and recommended phase II dose (RP2D)in patients with advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma, Non-Hodgkin
- What is being tested?
- QLF31907
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2021to 1 Jun 2024
- 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
- Subjects voluntarily participated and signed a written informed consent form
- Age ≥ 18 years, male or female
- ECOG performance status of 0 or 1
- Expected life-expectancy of more than 3 months
- Solid tumors:
- Patients with histologically diagnosed head and neck squamous cell carcinoma (HNSCC), esophageal cancer (EC), renal cancer (RCC), melanoma, cervical cancer (CC), non-oncogene driver NSCLC and other solid tumors (requiring MSI-H/ dMMR signature gene) that are locally advanced, recurrent or metastatic that have failed or are intolerant to standard therapy.
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- Hematologic tumors: patients with histologically diagnosed mediastinal large B-cell lymphoma (PMBCL), diffuse large B-cell lymphoma (DLBCL), mesenchymal large cell lymphoma (ALCL), peripheral T-cell lymphoma (PTCL), NKT-cell lymphoma, and high-grade B-cell lymphoma (R/R HGBL) that are intolerant or relapsed/refractory to standard therapy.
- Patients with solid tumors have at least 1 measurable lesion according to RECIST v1.1. Patients with lymphoma have at least 1 measurable lesion or hypermetabolic lesion with 18F-FDG (18F-fluorodeoxyglucose) uptake according to Lugano2014 evaluation criteria.
- Adequate organ function prior to first use of the trail drug (no blood components, cell growth factors, leukocyte-raising drugs, platelet-raising drugs, etc., or hepatoprotective therapy is allowed within 14 days prior to obtaining laboratory tests)
- Absolute neutrophil count ≥ 1.5 x 109/L
- Platelet count ≥ 80 × 109/L (≥ 90 × 109/L in patients with hepatocellular carcinoma)
- Hemoglobin ≥ 90g/L
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN); for patients with creatinine level > 1.5 × ULN, according to Cockcroft-Gault formula for creatinine clearance (CLcr) ≥ 60 mL / min
- Total bilirubin ≤ 1.5 × ULN
- AST and ALT ≤ 2.5 × ULN (for Gilbert's syndrome, hepatocellular carcinoma or the presence of liver metastases, ≤ 5 × ULN)
- Coagulation function: prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN
- Cardiac left ventricular ejection fraction (LVEF) > 50%
- Subjects (both female and male) agree to use effective contraception from the time they sign the informed consent form until 180 days after the last use of the trial drug.
- Recovery from all the other reversible AEs from prior antineoplastic therapy prior to the first administration of the trail drug (i.e. ≤ grade 1, according to CTCAE v5.0), excluding alopecia (any grade) and ≤ grade 2 peripheral sensory neuropathy or lymphocytopenia. Subjects who develop other abnormalities without clinically significant or investigator-judged risk-free toxicity will be enrolled only after discussion and approval by the sponsor and investigator.
Who cannot join
- Previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
- Received antitumor therapy with chemotherapy, biologic therapy, endocrine therapy, immunotherapy, or monoclonal antibodies within 4 weeks prior to the first use of the trail drug, with special circumstances as follows.
- Including those who have received oral fluorouracil analogues, small-molecule targeted drugs and herbal or Chinese patent medicine with antitumor indications within 2 weeks prior to the first use of the trail drug
- Including those who have received mitomycin or nitrosoureas within 6 weeks prior to the first use of the trail drug
- Including those who have received cell-based therapy or antitumor vaccine within 8 weeks prior to the first use of the trail drug
- In subjects with a high tumor burden, treatment to reduce tumor burden for the purpose of preventing tumor lysis syndrome during the course of the trial is excluded
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- Subjects with central nervous system (CNS) metastases or clinical manifestations of CNS involvement, soft meningeal metastases, or spinal cord compression due to metastases prior to signing informed consent. Except for symptomatic CNS metastases that have been treated and stable for ≥4 weeks prior to the first administration of the investigational drug and who have been off systemic hormone (at any dose) therapy for >2 weeks.
- Subjects with uncontrolled exudate or leaky fluid (thoracic, pericardial, or abdominal) or one of thoracic fluid >500 ml, pericardial fluid >100 ml, or abdominal fluid ≥1000 ml
- History of autoimmune disease (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [except for subjects who can be controlled by hormone replacement therapy only]; except for subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis and alopecia areata; except for type I diabetes or asthma that has completely resolved in childhood and does not require any intervention in adulthood, such as asthma patients who require medical intervention with bronchodilators are not included)
- Have had other active malignancies within 3 years prior to study entry (from the time of signing informed consent form). Cured basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast and papillary thyroid cancer were excluded
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis (hepatitis B: defined as positive hepatitis B virus surface antigen [HBsAg] and e antigen [HBeAg] test results, or HBV-DNA ≥ 20 IU/ml, or HBV-DNA ≥ 1000 copies/ml, or persistent liver function abnormal, or tissue biopsy with hepatitis pathology, or cirrhosis; hepatitis C: defined as positive hepatitis C antibody [HCV-Ab] and HCV-RNA above the lower limit of detection of the analytical method), combined hepatitis B and C co-infection; syphilis spirochete infection; Mycobacterium tuberculosis infection
- History of hepatitis (non-alcoholic steatohepatitis, alcoholic or autoimmune hepatitis) and cirrhosis
- Subjects with the following cardiovascular events including but not limited to: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency and clinically significant supraventricular or ventricular arrhythmias, prolonged QT interval and need for clinical intervention within 6 months prior to study entry (from the time of signing informed consent form); congenital heart disease such as clinically significant heart valve stenosis, insufficiency of closure and cardiomyopathy
- Systemic antibiotic use for ≥ 7 days within 4 weeks prior to first dose, or unexplained fever > 38.5°C during screening/prior to first dose (fever due to oncologic causes may be enrolled, as determined by the investigator)
- Subjects with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/history of bone marrow transplantation treatment, autologous stem cell transplantation within 180 days
- Participation in any other drug clinical study within 4 weeks prior to the first dose and use of other study drugs (except minerals, vitamins), or no more than 2 weeks from the last study drug (half-life ≤ 3 days) and no more than 28 days from the last study drug (half-life > 3 days)
- Subjects with a known history of psychotropic substance abuse, alcohol or drug abuse; a clear previous history of neurological or psychiatric disorders, including epilepsy or dementia.
- Known hypersensitivity to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies; or are allergic.
- Women who are pregnant or breastfeeding, except for women who are breastfeeding and may stop breastfeeding during the study; patients who are intending or planning to have children during the study.
- History of idiopathic pulmonary fibrosis, pneumoconiosis, asbestosis (including drug-induced lung injury)
- Active pneumonic lesions detected on CT chest scan during the screening period
- Systemic immunosuppressive therapy with drugs including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, and anti-TNFα (tumor necrosis factor) drugs, except for localized and short-term small doses use within 2 weeks of the first administration of trail drug
- Subjects who have undergone local radiation therapy for palliation within 7 days prior to the first dose; subjects who have received radiation therapy with more than 30% of the bone marrow irradiated or whole brain radiation therapy within 4 weeks prior to the first dose
- Combined second tumor requiring concurrent treatment with other antineoplastic agents (except hormonal therapy for breast and prostate cancer)
- Presence of uncontrolled or poorly controlled underlying respiratory, circulatory and endocrine diseases such as chronic obstructive pulmonary disease, hypertension, coronary artery disease, diabetes mellitus and hyperthyroidism
- Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the results of the study, and subjects who are not suitable for participation in this study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Bin Liu, 86 028-85420681, binliu322@126.com
Tongyu Lin
About this study
Official title: An Open, Dose-escalating Phase Ia Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLF31907 Injection in Patients With Advanced Cancer
This study is designed to evaluate the safety and tolerability of QLF31907 injection, to identify the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), and determine the recommended phase Ib dose(RPIbD) and recommended phase II dose (RP2D)in patients with advanced malignant tumors.
- Conditions
- Solid Tumor, Lymphoma, Non-Hodgkin
- Being tested
- QLF31907
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLF31907Drug
In this study, seven dose groups were proposed. The frequency of administration was once every two weeks, and four weeks was one therapeutic cycle. The subjects will receive six cycles of QLF31907 treatment at most.
| Study group | Role | What they receive |
|---|---|---|
| QLF31907 | Experimental | single arm with QLF31907 treatment Receives: Drug: QLF31907 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT)
The DLT of QLF31907 will be determined.
Measured: 28 days
Maximum tolerated dose(MTD)
The MTD of QLF31907 will be determined.
Measured: up to 2 years
Secondary outcomes (6)
Frequency of adverse events of QLF31907
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: up to 2 years
Cmax of QLF31907
Peak Plasma Concentration (Cmax) of QLF31907 will be determined.
Measured: up to 2 years
AUC of QLF31907
Area under the plasma concentration versus time curve (AUC) of QLF31907 will be determined.
Measured: up to 2 years
Tmax of QLF31907
Time to Cmax (Tmax) of QLF31907 will be determined.
Measured: up to 2 years
Immunogenicity of QLF31907
Frequency of anti-drug antibodies (ADA) against QLF31907 will be determined.
Measured: up to 2 years
Anti-tumor activity of QLF31907
Solid tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1), and lymphoma response will be determined by criteria of lugano 2014.
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 posted9 Dec 2021
- Study start19 Oct 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 54 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
- NCT05150405
- Sponsor's protocol ID
- QLF31907-101
- Status last verified
- Jan 2024
- First submitted
- 28 Oct 2021
- Last updated
- 23 Jan 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose-escalating Phase Ia Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLF31907 Injection in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05150405
- Acronym / sponsor ID
- QLF31907-101
- Conditions
- Solid Tumor, Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 9 Dec 2021 (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 tolerability of QLF31907 injection, to identify the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), and determine the recommended phase Ib dose(RPIbD) and recommended phase II dose (RP2D)in patients with advanced malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLF31907 | Experimental | Drug: QLF31907single arm with QLF31907 treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects voluntarily participated and signed a written informed consent form
- Age ≥ 18 years, male or female
- ECOG performance status of 0 or 1
- Expected life-expectancy of more than 3 months
- Solid tumors:
Key exclusion criteria (26 listed)
- Previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
- Received antitumor therapy with chemotherapy, biologic therapy, endocrine therapy, immunotherapy, or monoclonal antibodies within 4 weeks prior to the first use of the trail drug, with special circumstances as follows.
- Subjects with central nervous system (CNS) metastases or clinical manifestations of CNS involvement, soft meningeal metastases, or spinal cord compression due to metastases prior to signing informed consent. Except for symptomatic CNS metastases that have been treated and stable for ≥4 weeks prior to the first administration of the investigational drug and who have been off systemic hormone (at any dose) therapy for >2 weeks.
- Subjects with uncontrolled exudate or leaky fluid (thoracic, pericardial, or abdominal) or one of thoracic fluid >500 ml, pericardial fluid >100 ml, or abdominal fluid ≥1000 ml
- History of autoimmune disease (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [except for subjects who can be controlled by hormone replacement therapy only]; except for subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis and alopecia areata; except for type I diabetes or asthma that has completely resolved in childhood and does not require any intervention in adulthood, such as asthma patients who require medical intervention with bronchodilators are not included)
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 |
|---|---|---|
| QLF31907In this study, seven dose groups were proposed. The frequency of administration was once every two weeks, and four weeks was one therapeutic cycle. The subjects will receive six cycles of QLF31907 treatment at most. | Drug | QLF31907 |
Primary outcome
Dose-limiting toxicity(DLT)
Time frame: 28 days
The DLT of QLF31907 will be determined.
Maximum tolerated dose(MTD)
Time frame: up to 2 years
The MTD of QLF31907 will be determined.
6 secondary outcomes
Frequency of adverse events of QLF31907
Time frame: up to 2 years
Cmax of QLF31907
Time frame: up to 2 years
AUC of QLF31907
Time frame: up to 2 years
Tmax of QLF31907
Time frame: up to 2 years
Immunogenicity of QLF31907
Time frame: up to 2 years
Anti-tumor activity of QLF31907
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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. 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 QLF31907 in people with Solid Tumor and Lymphoma, Non-Hodgkin, 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 19 inclusion and 26 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 23 Jan 2024. 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 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 23 Jan 2024.