Advanced CancerPhase 1NCT03690154
A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML
A Phase 1 study testing FN-1501 in people with Advanced Cancer and Solid Tumors, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 3 sites in 2 countries.
Trial summary
This research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas. Different types of solid tumors are named for the type of cells that form them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Solid Tumors, Acute Myeloid Leukemia Refractory
- What is being tested?
- FN-1501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Jul 2018to 11 Feb 2022
- 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
- Male and female 18 years old and above
- Able to understand and sign informed consent form
- Patients with histologically or cytologically confirmed advanced solid tumors who have relapsed or refractory disease or relapsed/refractory AML for which no standard therapies expected to produce clinical benefit to the patient are available
- Patients with diagnosed solid tumors must have at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
- Patients with relapsed or refractory AML must be diagnosed with AML based on World Health Organization (WHO) criteria (≥ 20% blasts in bone marrow). Patients with acute promyelocytic leukemia are excluded
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
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- Have discontinued all previous cancer therapies for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute adverse effects of therapy
- Expected to survive at least 2 to 3 months
- LVEF ≥ 50% and QTc interval < 450 ms
- Women shall meet either of the following conditions before enrollment
- Infertile, defined as having a bilateral oophorectomy (ovariectomy), or a bilateral tubal ligation, or being post-menopausal for at least 1 year.
- For those of childbearing potential, they should have a negative serum pregnancy test during screening, agree to refrain from lactation, and use effective contraception such as hormonal methods associated with inhibition of ovulation, condom, intra-uterine device, surgical sterilization (including partner's vasectomy) or sexual abstinence during the study and 30 days after the last administration of study drug.
- Men who are engaging or plan to engage in sexual activity with a female of childbearing potential must either have a prior vasectomy or agree to use effective contraception such as condoms, sexual abstinence and appropriate methods taken by their partner(s) during the study and 90 days after the last dose.
- Patients must have adequate organ functions as indicated by the following screening laboratory values:
- Serum total bilirubin ≤ 1.5 × upper limit normal (ULN) (Serum total bilirubin can be ≤ 3.0 × ULN if patients have hemolysis or congenital hemolytic diseases)
- Creatinine < 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or
- 5 X ULN for patient with liver metastases
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
- Platelets ≥ 100×10^9/L
- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (Note: Criteria must be met without a transfusion within 2 weeks of obtaining the sample) Note: Laboratory requirements for complete blood counts (hemoglobin, ANC, and platelets) do not apply to AML patients
Who cannot join
- Participation in another therapeutic clinical trial within 3 weeks of enrollment
- A previous toxicity-related reaction towards cancer therapy have not recovered within 2 weeks of enrollment (>Grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03)
- Having received a major surgical operation within 4 weeks of enrollment or not yet completely recovered from a previous operation
- Any serious or uncontrollable systemic disease, including but not limited to: Hypertension (after treatment, systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg) and active hemorrhagic disorders; patients who are determined by investigators as otherwise not suitable for participation in this study.Note: Patients that in the judgment of the investigator have clinical signs of disease progression during the screening period (i.e.: febrile neutropenia, ascites requiring drainage, hospitalization due to worsening underlying disease, etc.) will not be eligible for participation.
- Active known infection, including hepatitis B, hepatitis C, and human immunodeficiency virus
- Primary central nervous system (CNS) tumor or CNS metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with a history of CNS metastases or cord compression are allowable if they have been definitively treated and have been clinically stable for at least 3 months, and off steroids or anticonvulsants ≥ 2 weeks before first dose of study drug)
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- Serious kidney injury, requiring dialysis
- Serious liver injury, and advanced liver diseases of Child-Pugh class B and C
- On medications that are strong cytochrome P450(CYP)3A inhibitors or inducers unless patients are willing and able to change to use of an equivalent medication that is not a strong CYP3A inhibitor or inducer
- Cardiac function and disease history which meets one or more of the following conditions:
- Any risk which may increase QTc interval prolongation, such as hypokalemia, hereditary long QT syndrome and taking drugs that can prolong QT interval
- Acute myocardial infarction ≤ 6 months prior to Day 1
- Clinically significant arrhythmia ≤ 6 months prior to Day 1
- Congestive heart failure ≥ Grade 3 by New York Heart Association (NYHA) ≤ 6 months prior to Day 1
- Cerebral vascular accident (CVA) ≤ 6 months prior to Day 1
- Are pregnant or breastfeeding
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Karmanos Cancer Institute
Detroit, Michigan, 48334
KUMC Cancer Center
Fairway, Kansas, 66205
About this study
Official title: A Phase 1, Multi-center, Open-label, Single-arm, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia (AML)
This research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas. Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors include lung cancer, breast cancer, prostate cancer, kidney cancer, colorectal cancer, melanoma and sarcoma.
The purpose of this research study is to evaluate the safety of the investigational study drug, FN-1501, at different dose levels. FN-1501 has not previously been given to human subjects. It is intended for the treatment in this study of patients with advanced solid tumor cancers. This study will determine the effects, good and/or bad, on patients' cancer. The main objective of this study is to define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of FN-1501. The MTD is the highest dose a person can take without having bad side effects, and the RP2D will be the dose of FN-1501 used in future studies.
Read the detailed description
This is a phase 1, first-in-human, open-label, multicenter, dose escalation study.
Dose escalation will follow the traditional 3+3 design. Patients will be screened for eligibility for up to 28 days prior to entry into the study. The starting dose will be 2.5 mg/day (once daily). The period for DLT assessment is 21 days from the first dose of FN-1501. Evaluation of a cohort of at least three (3) patients completing DLT assessment at any given dose level is required prior to determining the next dose level and dose regimen for the subsequent cohort.
After the first patient in the cohort receives the Cycle 1, Day 1 dose, subsequent patients in that cohort will not be dosed until the first patient has been evaluated for at least 48 hours to exclude unexpected acute toxicity. The continuous safety evaluation will be performed by investigators, the medical monitor, and the sponsor. A Safety Monitoring Committee (SMC) will determine dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. If an MTD is not identified due to paucity of DLTs, the RP2D will be determined based on pharmacokinetics, safety, tolerability, and preliminary efficacy.
If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 21-day Cycle 2 and subsequent cycles (same as Cycle 2, all of 21 days' duration), defined as administration of 3 times per week for 2 weeks followed by one week off, at the discretion of the investigator.
The primary endpoint of this study is to determine the recommended phase 2 dose (RP2D) of FN-1501 based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.
- Conditions
- Advanced Cancer, Solid Tumors, Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse
- Being tested
- FN-1501
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FN-1501Drug
Eligible patients will receive a single intravenous infusion of study drug on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Dosing will begin at 2.5 mg once per day on the assigned days. Dose escalation will use the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day. At least 3 patients will be enrolled in each cohort. Administration of FN-1501 will be continued until disease progression, intolerable toxicity, withdrawal of consent, or termination according to the Principal Investigator's judgment or at the sponsor's request.
| Study group | Role | What they receive |
|---|---|---|
| FN-1501 | Experimental | Not described Receives: Drug: FN-1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Measured: From first dose until 30 days after the last dose.
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
The recommended phase 2 dose (RP2D) of FN-1501 will be determined based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.
Measured: During the first year.
Secondary outcomes (10)
Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-last)
Measured: During the first year.
Area under concentration-time curve from 0 to 24 hours (AUC(0-24))
Measured: During the first year.
Area under the plasma concentration time curve from zero to infinity (AUC0-∞)
Measured: During the first year.
Maximum observed plasma concentration (Cmax)
Measured: During the first year.
Time to maximum observed plasma concentration (tmax)
Measured: During the first year.
Terminal half-life (t1/2)
Measured: During the first year.
Clearance (CL)
Measured: During the first year.
Apparent volume of distribution (Vd)
Measured: During the first year.
Measurement of anti-tumor activity of FN-1501 according to RECIST version 1.1 (solid tumor)
Measured: During the first year.
Measurement of anti-tumor activity of FN-1501 including but not limited to CT/MRI images
Measured: During the first year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start23 Jul 2018
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Why it stopped: Despite demonstrated safety and tolerability the trial was terminated early due to program re-prioritization in light of the competitive landscape.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ai-Min Hui, MD, PhD, Study director, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690154
- Sponsor's protocol ID
- FN-1501-UP1
- Status last verified
- Jul 2022
- First submitted
- 21 Sep 2018
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Open-label, Single-arm, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT03690154
- Acronym / sponsor ID
- FN-1501-UP1
- Conditions
- Advanced Cancer, Solid Tumors, Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite demonstrated safety and tolerability the trial was terminated early due to program re-prioritization in light of the competitive landscape.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 1 Oct 2018 (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 research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas. Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors include lung cancer, breast cancer, prostate cancer, kidney cancer, colorectal cancer, melanoma and sarcoma.
The purpose of this research study is to evaluate the safety of the investigational study drug, FN-1501, at different dose levels. FN-1501 has not previously been given to human subjects. It is intended for the treatment in this study of patients with advanced solid tumor cancers. This study will determine the effects, good and/or bad, on patients' cancer. The main objective of this study is to define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of FN-1501. The MTD is the highest dose a person can take without having bad side effects, and the RP2D will be the dose of FN-1501 used in future studies.
Detailed description
This is a phase 1, first-in-human, open-label, multicenter, dose escalation study.
Dose escalation will follow the traditional 3+3 design. Patients will be screened for eligibility for up to 28 days prior to entry into the study. The starting dose will be 2.5 mg/day (once daily). The period for DLT assessment is 21 days from the first dose of FN-1501. Evaluation of a cohort of at least three (3) patients completing DLT assessment at any given dose level is required prior to determining the next dose level and dose regimen for the subsequent cohort.
After the first patient in the cohort receives the Cycle 1, Day 1 dose, subsequent patients in that cohort will not be dosed until the first patient has been evaluated for at least 48 hours to exclude unexpected acute toxicity. The continuous safety evaluation will be performed by investigators, the medical monitor, and the sponsor. A Safety Monitoring Committee (SMC) will determine dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. If an MTD is not identified due to paucity of DLTs, the RP2D will be determined based on pharmacokinetics, safety, tolerability, and preliminary efficacy.
If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 21-day Cycle 2 and subsequent cycles (same as Cycle 2, all of 21 days' duration), defined as administration of 3 times per week for 2 weeks followed by one week off, at the discretion of the investigator.
The primary endpoint of this study is to determine the recommended phase 2 dose (RP2D) of FN-1501 based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FN-1501 | Experimental | Drug: FN-1501 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male and female 18 years old and above
- Able to understand and sign informed consent form
- Patients with histologically or cytologically confirmed advanced solid tumors who have relapsed or refractory disease or relapsed/refractory AML for which no standard therapies expected to produce clinical benefit to the patient are available
- Patients with diagnosed solid tumors must have at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
- Patients with relapsed or refractory AML must be diagnosed with AML based on World Health Organization (WHO) criteria (≥ 20% blasts in bone marrow). Patients with acute promyelocytic leukemia are excluded
Key exclusion criteria (16 listed)
- Participation in another therapeutic clinical trial within 3 weeks of enrollment
- A previous toxicity-related reaction towards cancer therapy have not recovered within 2 weeks of enrollment (>Grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03)
- Having received a major surgical operation within 4 weeks of enrollment or not yet completely recovered from a previous operation
- Any serious or uncontrollable systemic disease, including but not limited to: Hypertension (after treatment, systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg) and active hemorrhagic disorders; patients who are determined by investigators as otherwise not suitable for participation in this study.Note: Patients that in the judgment of the investigator have clinical signs of disease progression during the screening period (i.e.: febrile neutropenia, ascites requiring drainage, hospitalization due to worsening underlying disease, etc.) will not be eligible for participation.
- Active known infection, including hepatitis B, hepatitis C, and human immunodeficiency virus
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 |
|---|---|---|
| FN-1501Eligible patients will receive a single intravenous infusion of study drug on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Dosing will begin at 2.5 mg once per day on the assigned days. Dose escalation will use the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day. At least 3 patients will be enrolled in each cohort. Administration of FN-1501 will be continued until disease progression, intolerable toxicity, withdrawal of consent, or termination according to the Principal Investigator's judgment or at the sponsor's request. | Drug | FN-1501 |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time frame: From first dose until 30 days after the last dose.
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Time frame: During the first year.
The recommended phase 2 dose (RP2D) of FN-1501 will be determined based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.
10 secondary outcomes
Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-last)
Time frame: During the first year.
Area under concentration-time curve from 0 to 24 hours (AUC(0-24))
Time frame: During the first year.
Area under the plasma concentration time curve from zero to infinity (AUC0-∞)
Time frame: During the first year.
Maximum observed plasma concentration (Cmax)
Time frame: During the first year.
Time to maximum observed plasma concentration (tmax)
Time frame: During the first year.
Terminal half-life (t1/2)
Time frame: During the first year.
Clearance (CL)
Time frame: During the first year.
Apparent volume of distribution (Vd)
Time frame: During the first year.
Measurement of anti-tumor activity of FN-1501 according to RECIST version 1.1 (solid tumor)
Time frame: During the first year.
Measurement of anti-tumor activity of FN-1501 including but not limited to CT/MRI images
Time frame: During the first year.
Results and safety
The study was stopped early (reason given: Despite demonstrated safety and tolerability the trial was terminated early due to program re-prioritization in light of the competitive landscape.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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.
Ai-Min Hui, MD, PhD study director
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FN-1501 in people with Advanced Cancer and Solid Tumors, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 3 sites in 2 countries.
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 21 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. 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?
The study was stopped early (reason given: Despite demonstrated safety and tolerability the trial was terminated early due to program re-prioritization in light of the competitive landscape.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (time frame: From first dose until 30 days after the last dose.). 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 13 Oct 2023.