Solid TumorsPhase 1/2NCT05740215
Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors
A Phase 1/2 study testing F520 and Lenvatinib in people with Solid Tumors, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
This is a multicenter, open-label, phase Ib/II study on the efficacy and safety of F520 combined with lenvatinib in the treatment of patients with advanced solid tumors. About 138~158 patients with advanced solid tumors plan to be enrolled in about 30 study sites of the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- F520 and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2022to 22 May 2024
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase Ib:
- Male or female aged ≥18 years and ≤75 years old;
- Study population: confirmed by histological and/or cytological examination patients with solid tumors (endometrial cancer, cervical cancer, non-small cell lung cancer, urothelial carcinoma, etc.), patients with metastatic solid tumors who have failed (disease progression or intolerance) after adequate standard treatment or lack effective treatments;
- Expected survival period ≥ 12 weeks;
- ECOG 0-1 points;
- Blood pressure (BP) is adequately controlled with or without antihypertensive drugs, defined as BP ≤ 150/90 mmHg and unchanged antihypertensive drugs within 1 week prior to enrollment;
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- Vital organ functions meet the following requirements (Reception of granulocyte colony-stimulating factor (G-CSF) or pegylated granulocyte colony-stimulating factor (PEG-G-CSF) or blood transfusion within 14 days prior to laboratory tests is not permitted for prophylactic use):
- Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90 g/L, platelet count (PLT) ≥ 75 ×109/L, lymphocyte percentage≥10%; liver function: total bilirubin level (TBIL)≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40mL/min (Cr>1.5×ULN); Coagulation function: international normalized ratio (INR) ≤1.5×ULN;
- Aagree to provide archived tumor tissue samples Or fresh tissue samples;
- Those who understand and voluntarily sign the written informed consent.
- Phase II:
- Women aged ≥18 years and ≤75 years old;
- Study population:
- Cohort 1: Patients with recurrent or metastatic endometrial cancer (except carcinosarcoma) who have progressed after receiving at least one line of treatment, and the number of previous platinum-containing treatment lines is ≤ 2; Cohort 2: patients with recurrent or metastatic cervical cancer (Squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma) who have progressed after receiving at least one line of platinum-containing regimens and adenosquamous carcinoma); those who progressed during or within 6 months after receiving platinum-containing regimen neoadjuvant or adjuvant chemotherapy can also be included;
- Expected survival ≥ 12 weeks;
- According to the RECIST1.1 standard, the subject patients must have at least one measurable target lesion (extranodal lesions: long diameter ≥ 10mm; intranodal lesions: short diameter ≥ 15mm) by enhanced CT and/or enhanced MRI;
- ECOG 0-1 points;
- Adequate control of blood pressure (BP) with or without antihypertensive drugs, defined as BP ≤ 150/90 mmHg and antihypertensive drugs remained unchanged within 1 week before enrollment;
- Vital organ functions meet the following requirements (Reception of granulocyte colony-stimulating factor (G-CSF) or pegylated granulocyte colony-stimulating factor (PEG-G-CSF) or blood transfusion within 14 days prior to laboratory tests is not permitted for prophylactic use):
- Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90 g/L, platelet count (PLT) ≥ 75 ×109/L, lymphocyte percentage≥10%; liver function: total bilirubin level (TBIL)≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40mL/min (Cr>1.5×ULN); Coagulation function: international normalized ratio (INR) ≤1.5×ULN;
- Those who agree to provide archived tumor tissue samples or fresh tissue samples;
- Those who understand and voluntarily sign the written informed consent.
Who cannot join
- Those who have received systemic tumor therapy of radiotherapy, chemotherapy, traditional Chinese medicine, hormone therapy, surgery, targeted therapy or antibody drugs within 28 days (or 5 half-lives of the drug, whichever is shorter) before the first dose; Those whose toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except alopecia);
- Those who have previously received any angiogenic drugs that directly target VEGF (Subjects who have only used bevacizumab in the past can be enrolled), anti-PD-1, anti-PD-L1, anti-PD-L2 or any other Antibody or drug therapy that specifically targets T cell co-stimulation or checkpoint pathways;
- Subjects with central nervous system (CNS) metastases, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery, or radiosurgery) and have stopped corticosteroid therapy at least 4 weeks prior to the start of study treatment;
- Inability to swallow or disease/surgery significantly affects gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, bariatric surgery, symptomatic inflammatory bowel disease, etc.;
- Partial or complete intestinal obstruction or intestinal obstruction occurred within 1 month before the first administration;
- Have suffered from interstitial lung disease, non-infectious pneumonia or uncontrolled lung disease in the past 3 years, including but not limited to pulmonary fibrosis, acute lung disease, etc.;
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- Those with uncontrollable or severe cardiovascular diseases, such as New York Heart Association (NYHA) congestive heart failure above grade II, unstable angina, myocardial infarction and other cardiovascular diseases occurring within 6 months before the first administration;
- QTcF ≥ 480 milliseconds (QT interval must use Fridericia formula for heart rate correction [QTcF]);
- Within 3 months before the first dose, there were clinically significant hematuria, hematemesis or hemoptysis (>2.5 mL red blood), or other medical history of significant bleeding (such as pulmonary hemorrhage);
- Those with thrombosis who need treatment in the acute phase;
- Active hepatitis patients (HBV DNA>2000 IU/mL or 1000 copies of chronic hepatitis B or chronic HBV carriers; HCV positive and HCV-RNA positive hepatitis C patients); human immunodeficiency virus (HIV) antibody positive; Treponema pallidum (TP) antibody positive;
- Subjects with urine protein>1+ receive 24-hour urine protein quantification, urine protein ≥1g/24 hours;
- Those with a known history of contraindications or hypersensitivity to any test drug or any known excipients;
- Those who have had organ transplantation in the past or received autologous stem cell transplantation within 3 months before the first administration;
- Those with a history of other malignant tumors within the past 3 years, except locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix);
- Immunosuppressant, systemic or local hormone therapy has been used within 14 days before the first administration to achieve the purpose of immunosuppression (daily dose equivalent to prednisone > 10 mg of systemic corticosteroids);
- Those with a history of drug abuse and alcoholism within 6 months before the first administration;
- Active autoimmune disease requiring systemic treatment within the past 2 years (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs), alternative therapy (such as physiological corticosteroid replacement therapy for thyroxine, insulin, or adrenal or pituitary insufficiency, etc.) is not considered a systemic treatment;
- Those who received (attenuated) live vaccines within 30 days before the first administration (except for inactivated influenza vaccines such as injectable seasonal influenza vaccines and COVID-19 vaccines);
- Pregnant or breastfeeding women, female subjects of childbearing age or male subjects whose partner is a woman of childbearing age do not agree to use highly effective methods of contraception during the study period and within 6 months after the last study drug treatment;
- Those judged by the researchers to be unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Xiaohua Tang, 023-65075696, czll5545@126.com
Qi zhou
About this study
Official title: A Multicenter, Open-label, Phase Ib/II Study on the Efficacy and Safety of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors
This is a multicenter, open-label, phase Ib/II study on the efficacy and safety of F520 combined with lenvatinib in the treatment of patients with advanced solid tumors. About 138~158 patients with advanced solid tumors plan to be enrolled in about 30 study sites of the study.
Part I: Phase Ib study evaluating the safety and tolerability of F520 combined with lenvatinib in patients with advanced solid tumors.
Part II: Phase II study of F520 combined with lenvatinib in endometrial cancer and cervical cancer.
- Conditions
- Solid Tumors
- Being tested
- F520, Lenvatinib
- Keywords
- F520, PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F520Drug
F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2)
LenvatinibDrug
Lenvatinib capsules
| Study group | Role | What they receive |
|---|---|---|
| F520 combined with lenvatinib | Experimental | F520:
F520 (200 mg) administered intravenously (IV) on Day 1 of each 21-day cycle in the phase Ib and II studies until progressive disease, unacceptable toxicity or ending treatment for other reasons. [Time Frame: up to 2 years post infusion]
Lenvatinib:
In the phase Ib study, three dose groups of 20 mg, 16 mg and 12 mg lenvatinib were designed. 3 to 6 subjects are expected to be enrolled in each dose group according to observed DLT. The designated dose of lenvatinib administered orally once daily (QD) according to the assigned dose group.
In the phase II study, lenvatinib administered orally once daily (QD) according to recommended phase II dose (RP2D) obtained in phase Ib study. Receives: Drug: F520; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Phase Ib: The incidence of adverse events/serious adverse events, their correlation with the trial drug and their severity.
Measured: 21 days after first dose
Adverse events
Phase Ib: The incidence of adverse events/serious adverse events, their correlation with the trial drug and their severity.
Measured: 21 days after first dose
Dose-limiting toxicity (DLT)
Phase Ib: Assess the incidence of dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Measured: 21 days after first dose
Maximum tolerated dose (MTD)
Phase Ib: Assess the incidence of dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Measured: 21 days after first dose
Phase II recommended dose (RP2D).
Phase Ib: Assess the incidence of dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Measured: 21 days after first dose
Objective Response Rate (ORR)
Phase II: Objective Response Rate (ORRW24) evaluated by the Independent Review Committee (IRC) based on RECIST 1.1.
Measured: 24 weeks
Secondary outcomes (9)
Objective response rate (ORR)
Phase Ib: To determine the preliminary efficacy by evaluating the objective response rate (ORR) of F520 combined with lenvatinib in patients with advanced solid tumors (The last subject completed the 8th cycle of administration and completed the corresponding visits).
Measured: through study completion, an average of 2 year
Maximum Plasma Concentration (Cmax）
Phase Ib: To evaluate the pharmacokinetic characteristics of F520 and lenvatinib in patients with advanced solid tumors.
Measured: 30 days (±7 days) after the last dose, early withdrawal or occurrence of SAE or grade ≥ 3 TRAE related to the study drug
Objective response rate (ORR)
Phase II: The objective response rate evaluated by the investigator based on RECIST 1.1 (ORRW24).
Measured: 24 weeks
PFS
Phase II: PFS evaluated by IRC and investigator based on RECIST.
Measured: through study completion, an average of 2 year
PFS
Phase II: PFS evaluated by IRC and investigator based on iRECIST.
Measured: through study completion, an average of 2 year
Adverse events
Phase II: Evaluate the number and percent of patients with adverse events/adverse reactions and serious adverse events/severe adverse reactions in selected patients with advanced solid tumors treated with F520 combined with lenvatinib.
Measured: 30 days after the last dose
Adverse reactions
Phase II: Evaluate the number and percent of patients with adverse events/adverse reactions and serious adverse events/severe adverse reactions in selected patients with advanced solid tumors treated with F520 combined with lenvatinib.
Measured: 30 days after the last dose
Serious adverse events
Phase II: Evaluate the number and percent of patients with adverse events/adverse reactions and serious adverse events/severe adverse reactions in selected patients with advanced solid tumors treated with F520 combined with lenvatinib.
Measured: 30 days after the last dose
Severe adverse reactions
Phase II: Evaluate the number and percent of patients with adverse events/adverse reactions and serious adverse events/severe adverse reactions in selected patients with advanced solid tumors treated with F520 combined with lenvatinib.
Measured: 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start23 May 2022
- Primary completion22 May 2024 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740215
- Sponsor's protocol ID
- NTP-F520-102
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 22 Feb 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase Ib/II Study on the Efficacy and Safety of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05740215
- Acronym / sponsor ID
- NTP-F520-102
- Conditions
- Solid Tumors
- Keywords
- F520, PD-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 22 May 2024 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 22 Feb 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 is a multicenter, open-label, phase Ib/II study on the efficacy and safety of F520 combined with lenvatinib in the treatment of patients with advanced solid tumors. About 138~158 patients with advanced solid tumors plan to be enrolled in about 30 study sites of the study.
Part I: Phase Ib study evaluating the safety and tolerability of F520 combined with lenvatinib in patients with advanced solid tumors.
Part II: Phase II study of F520 combined with lenvatinib in endometrial cancer and cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F520 combined with lenvatinib | Experimental | Drug: F520, Drug: LenvatinibF520: F520 (200 mg) administered intravenously (IV) on Day 1 of each 21-day cycle in the phase Ib and II studies until progressive disease, unacceptable toxicity or ending treatment for other reasons. [Time Frame: up to 2 years post infusion] Lenvatinib: In the phase Ib study, three dose groups of 20 mg, 16 mg and 12 mg lenvatinib were designed. 3 to 6 subjects are expected to be enrolled in each dose group according to observed DLT. The designated dose of lenvatinib administered orally once daily (QD) according to the assigned dose group. In the phase II study, lenvatinib administered orally once daily (QD) according to recommended phase II dose (RP2D) obtained in phase Ib study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female aged ≥18 years and ≤75 years old;
- Study population: confirmed by histological and/or cytological examination patients with solid tumors (endometrial cancer, cervical cancer, non-small cell lung cancer, urothelial carcinoma, etc.), patients with metastatic solid tumors who have failed (disease progression or intolerance) after adequate standard treatment or lack effective treatments;
- Expected survival period ≥ 12 weeks;
- ECOG 0-1 points;
- Blood pressure (BP) is adequately controlled with or without antihypertensive drugs, defined as BP ≤ 150/90 mmHg and unchanged antihypertensive drugs within 1 week prior to enrollment;
Key exclusion criteria (21 listed)
- Those who have received systemic tumor therapy of radiotherapy, chemotherapy, traditional Chinese medicine, hormone therapy, surgery, targeted therapy or antibody drugs within 28 days (or 5 half-lives of the drug, whichever is shorter) before the first dose; Those whose toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except alopecia);
- Those who have previously received any angiogenic drugs that directly target VEGF (Subjects who have only used bevacizumab in the past can be enrolled), anti-PD-1, anti-PD-L1, anti-PD-L2 or any other Antibody or drug therapy that specifically targets T cell co-stimulation or checkpoint pathways;
- Subjects with central nervous system (CNS) metastases, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery, or radiosurgery) and have stopped corticosteroid therapy at least 4 weeks prior to the start of study treatment;
- Inability to swallow or disease/surgery significantly affects gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, bariatric surgery, symptomatic inflammatory bowel disease, etc.;
- Partial or complete intestinal obstruction or intestinal obstruction occurred within 1 month before the first administration;
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 |
|---|---|---|
| F520F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2) | Drug | F520 combined with lenvatinib |
| LenvatinibLenvatinib capsules | Drug | F520 combined with lenvatinib |
Primary outcome
Serious adverse events
Time frame: 21 days after first dose
Phase Ib: The incidence of adverse events/serious adverse events, their correlation with the trial drug and their severity.
Adverse events
Time frame: 21 days after first dose
Phase Ib: The incidence of adverse events/serious adverse events, their correlation with the trial drug and their severity.
Dose-limiting toxicity (DLT)
Time frame: 21 days after first dose
Phase Ib: Assess the incidence of dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Maximum tolerated dose (MTD)
Time frame: 21 days after first dose
Phase Ib: Assess the incidence of dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Phase II recommended dose (RP2D).
Time frame: 21 days after first dose
Phase Ib: Assess the incidence of dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Objective Response Rate (ORR)
Time frame: 24 weeks
Phase II: Objective Response Rate (ORRW24) evaluated by the Independent Review Committee (IRC) based on RECIST 1.1.
9 secondary outcomes
Objective response rate (ORR)
Time frame: through study completion, an average of 2 year
Maximum Plasma Concentration (Cmax）
Time frame: 30 days (±7 days) after the last dose, early withdrawal or occurrence of SAE or grade ≥ 3 TRAE related to the study drug
Objective response rate (ORR)
Time frame: 24 weeks
PFS
Time frame: through study completion, an average of 2 year
PFS
Time frame: through study completion, an average of 2 year
Adverse events
Time frame: 30 days after the last dose
Adverse reactions
Time frame: 30 days after the last dose
Serious adverse events
Time frame: 30 days after the last dose
Severe adverse reactions
Time frame: 30 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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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 1/2 study testing F520 and Lenvatinib in people with Solid Tumors, run by Shandong New Time 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 22 inclusion and 21 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 22 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi zhou, MMed (13708384529, qizhou9128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (time frame: 21 days after first dose). The study lists 6 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 22 Feb 2023.