Soft Tissue SarcomaPhase 1DOXO75NCT04032964
Dose Finding Study of L19TNF and Doxorubicin in Patients With STS
A Phase 1 study testing L19TNF and DOXORUBICIN in people with Soft Tissue Sarcoma, run by Philogen S.p.A. at 1 site in United States.
Trial summary
The study is aimed at evaluating the safety of L19TNF in combination with the most appropriate dose of doxorubicin. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- L19TNF and DOXORUBICIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years.
- Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Note: Evidence of disease progression is required for participants that are not newly diagnosed.
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. If only one lesion is present at screening this lesion should not have been irradiated during previous treatments.
- Life expectancy of at least 3 months in the judgment of the investigator.
- ECOG ≤ 2.
- Documented negative test for HIV-HBV-HCV. For HBV serology: the determination of HBsAg, anti-HBsAg-Ab and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
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- Female patients: negative serum pregnancy test for women of childbearing potential (WOCBP)* within 14 days of starting treatment. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Male patients: Male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g. condom with spermicidal gel). Double-barrier contraception is required.
- Informed consent signed and dated to participate in the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)
Who cannot join
- Diagnosis of GIST or Kaposi sarcoma.
- Prior therapy (except surgery and radiation) for this presentation of unresectable or metastatic malignant soft tissue sarcoma.
- Previous treatment with anthracycline- or anthracenedione-containing chemotherapy.
- Radiotherapy within 3 weeks (21 days) prior to therapy and previous radiation therapy to the mediastinal or pericardial area.
- Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis). Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before randomization to rule out brain metastasis.
- Known history of allergy to TNF, anthracyclines, or other intravenously administered human proteins/peptides/antibodies.
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- Absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L and hemoglobin (Hb) < 9.0 g/dl.
- Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN.
- Inadequate liver function (ALT, AST, ALP or total bilirubin ≥ 2.5 x ULN).
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- History within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
- Clinically significant cardiac arrhythmias or requiring permanent medication.
- Abnormalities observed during baseline ECG and ECHO investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of QT/QTc prolongation would be excluded. In particular:
- patients with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of QTc >480 milliseconds using Fredricia's QT correction formula) are excluded;
- patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded;
- patients who require the use of concomitant medications that prolong the QT/QTc interval are excluded.
- Uncontrolled hypertension.
- Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
- Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
- Pregnancy or breast-feeding.
- Requirement of chronic administration of corticosteroids or other immunosuppressant drugs. Limited use of corticosteroids to treat or prevent infusion-related reactions and hypersensitivity reactions is not considered an exclusion criterion.
- Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Known active or latent tuberculosis (TB).
- Concurrent malignancies other than soft tissue sarcoma, unless the patient has been disease-free for at least 2 years.
- Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
- Serious, non-healing wound, ulcer or bone fracture.
- Allergy to study medication or excipients in study medication.
- Concurrent therapy with anticoagulants.
- Concurrent use of other anti-cancer treatments or agents other than study medication.
- Any recent live vaccination within 4 weeks prior to treatment or plan to receive vaccination during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Research Center (SORC) Cancer Center of Southern California
Santa Monica, California, 90403
About this study
Official title: A Dose Finding Study of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Combination With Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma
The study is aimed at evaluating the safety of L19TNF in combination with the most appropriate dose of doxorubicin.
Read the detailed description
Open-label, phase 1 dose confirmation study in patients with advanced, unresectable and/or metastatic soft tissue sarcoma.
Six (6) Patients will be enrolled sequentially and will be treated according to the following scheme:
- Doxorubicin 75 mg/m2 i.v. on day 1 of each 21-day cycle L19TNF 13 µg/kg i.v. on day 1,3 and 5 of each 21-day cycle Initiation of the study treatment for an individual subject will occur no less than 3 days after initiation of the study treatment for the previous patient. Not more than 2 patients are to be treated simultaneously in Cycle 1.
Should unacceptable toxicities occur in ≥ 2 patients during the observation period from Day 1 to Day 21 (first cycle), enrollment will be stopped.
If a patient is not evaluable for unacceptable toxicity, he/she will be replaced.
Patients will be treated in repeated cycles until the treatment or when one of the following criteria are met:
- Unacceptable toxicity
- Disease Progression or relapse
- The patient or the investigator requests the treatment discontinuation
- The patient meets a withdrawal criterion. Patients with SD or PR (according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 evaluation) after the maximum of 6 cycles of study treatment, will receive maintenance therapy for up to 18 maintenance cycles from start of treatment, toxicity or until disease progression occurs. Maintenance can start immediately after the end of cycle 6 and consists infusions of L19TNF on Day 1 of each maintenance cycle (every 3 weeks) and doxorubicin on Day 1 of maintenance cycle 1 and 2 (if appropriate).
The primary objective is to evaluate the safety of L19TNF in combination with doxorubicin and to establish a recommended dose (RD), assessed as follows:
- Adverse events (AEs), serious adverse events (SAE) and drug induced liver injury (DILI) assessment based on Common Terminology Criteria for Adverse Events (CTCAE) v.5.0
- Standard laboratory (hematology, biochemistry and urinalysis) parameters.
- Electrocardiogram (ECG) and echocardiogram (ECHO) findings. In particular, data about QT/QTc intervals will be collected and analyzed for QT/QTc prolongation potentially caused by treatment.
- Physical examination findings including assessment of vital signs and physical measurements.
The secondary objective of the study is to evaluate signs of efficacy measured as progression-free survival (PFS) rate at 3, 6, 9, 12 and 18 months.
The other secondary objectives of the study are as follows:
- Efficacy of L19TNF in combination with doxorubicin:
- Overall response rate (ORR, consisting of CR and PR).
- Disease Control Rate (DCR, i.e. complete response (CR), partial response (PR) and stable disease (SD))
- Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19TNF.
- Characterization of pharmacokinetics (PK) of L19TNF and doxorubicin
- Conditions
- Soft Tissue Sarcoma
- Being tested
- L19TNF, DOXORUBICIN
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L19TNFDrug
L19TNF 13 µg/kg i.v. will be administered on day 1, 3 and 5 of each 21-day cycle
DOXORUBICINDrug
Doxorubicin 75 mg/m2 will be administered on day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm L19TNF + DOXO | Experimental | Patients will be treated with:
* doxorubicin 75 mg/m2 i.v. on day 1 of each 21-day cycle;
* L19TNF 13 µg/kg i.v. on day 1, 3 and 5 of each 21-day cycle Receives: Drug: L19TNF; Drug: DOXORUBICIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of Adverse events (AE)
Adverse event (AE) for the assessment of safety (CTCAE v. 5.0)
Measured: From week 1 to week 72
Number and type of Serious Adverse events (SAE)
Serious Adverse Events (SAE) for the assessment of safety (CTCAE v. 5.0)
Measured: From week 1 to week 72
Number and type of Drug induced liver injury (DILI)
Drug induced liver injury (DILI) assessment based on CTCAE v.5.0
Measured: From week 1 to week 72
Electrocardiogram (ECG) findings
Electrocardiogram (ECG) findings. In particular, data about QT/QTc intervals will be collected and analyzed for QT/QTc prolongation potentially caused by treatment.
Measured: From week 1 to week 72
Echocardiogram (ECHO) findings
Echocardiogram (ECHO) findings. In particular, data about QT/QTc intervals will be collected and analyzed for QT/QTc prolongation potentially caused by treatment.
Measured: From week 1 to week 72
Calculation of the body surface area (BSA)
BSA
Measured: From week 1 to week 72
Measurement of body weight
Measurement of body weight
Measured: From week 1 to week 72
Heart rate
Measurement of heart rate
Measured: From week 1 to week 72
Blood pressure
Measurement of blood pressure
Measured: From week 1 to week 72
ECOG performance status
Measured: From week 1 to week 72
Secondary outcomes (6)
Progression-free survival (PFS) rate
To evaluate signs of efficacy measured as progression-free survival (PFS) rate
Measured: 3, 6, 9, 12 and 18 months
Efficacy of L19TNF in combination with doxorubicin: Overall response rate
Overall response rate (ORR, consisting of CR and PR)
Measured: 3, 6, 9, 12 and 18 months
Efficacy of L19TNF in combination with doxorubicin: Disease Control Rate
Disease Control Rate (DCR, consisting of CR, PR and SD)
Measured: 3, 6, 9, 12 and 18 months
HAFA measurement
Assessment of the formation of Human anti-fusion protein antibodies (HAFA) against L19TNF
Measured: Treatment phase: at day 1 of cycle 1, at day 8 of week 1, at day 1 of cycle 2 and at day 1 of every cycle; at day 1 of every maintenance cycle (each cycle is 21 days)
PK value of L19TNF
Measurement of AUC value of L19TNF
Measured: Cycle 1 day 1, Cycle 1 day 2, cycle 1 day 3 and cycle 1 day 5 (each cycle is 21 days)
PK value of doxorubicin
Measurement of AUC value of doxorubicin
Measured: Cycle 1 day 1, Cycle 1 day 2, cycle 1 day 3 and cycle 1 day 5 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start5 Sep 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.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
- Model description
- Open-label, phase 1 dose confirmation study in patients with advanced, unresectable and/or metastatic soft tissue sarcoma
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032964
- Sponsor's protocol ID
- PH-L19TNFDOX75-02/19
- Acronym
- DOXO75
- Status last verified
- Apr 2024
- First submitted
- 28 Jun 2019
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Combination With Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT04032964
- Acronym / sponsor ID
- DOXO75 / PH-L19TNFDOX75-02/19
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jul 2019 (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.
The study is aimed at evaluating the safety of L19TNF in combination with the most appropriate dose of doxorubicin.
Detailed description
Open-label, phase 1 dose confirmation study in patients with advanced, unresectable and/or metastatic soft tissue sarcoma.
Six (6) Patients will be enrolled sequentially and will be treated according to the following scheme:
- Doxorubicin 75 mg/m2 i.v. on day 1 of each 21-day cycle L19TNF 13 µg/kg i.v. on day 1,3 and 5 of each 21-day cycle Initiation of the study treatment for an individual subject will occur no less than 3 days after initiation of the study treatment for the previous patient. Not more than 2 patients are to be treated simultaneously in Cycle 1.
Should unacceptable toxicities occur in ≥ 2 patients during the observation period from Day 1 to Day 21 (first cycle), enrollment will be stopped.
If a patient is not evaluable for unacceptable toxicity, he/she will be replaced.
Patients will be treated in repeated cycles until the treatment or when one of the following criteria are met:
- Unacceptable toxicity
- Disease Progression or relapse
- The patient or the investigator requests the treatment discontinuation
- The patient meets a withdrawal criterion. Patients with SD or PR (according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 evaluation) after the maximum of 6 cycles of study treatment, will receive maintenance therapy for up to 18 maintenance cycles from start of treatment, toxicity or until disease progression occurs. Maintenance can start immediately after the end of cycle 6 and consists infusions of L19TNF on Day 1 of each maintenance cycle (every 3 weeks) and doxorubicin on Day 1 of maintenance cycle 1 and 2 (if appropriate).
The primary objective is to evaluate the safety of L19TNF in combination with doxorubicin and to establish a recommended dose (RD), assessed as follows:
- Adverse events (AEs), serious adverse events (SAE) and drug induced liver injury (DILI) assessment based on Common Terminology Criteria for Adverse Events (CTCAE) v.5.0
- Standard laboratory (hematology, biochemistry and urinalysis) parameters.
- Electrocardiogram (ECG) and echocardiogram (ECHO) findings. In particular, data about QT/QTc intervals will be collected and analyzed for QT/QTc prolongation potentially caused by treatment.
- Physical examination findings including assessment of vital signs and physical measurements.
The secondary objective of the study is to evaluate signs of efficacy measured as progression-free survival (PFS) rate at 3, 6, 9, 12 and 18 months.
The other secondary objectives of the study are as follows:
- Efficacy of L19TNF in combination with doxorubicin:
- Overall response rate (ORR, consisting of CR and PR).
- Disease Control Rate (DCR, i.e. complete response (CR), partial response (PR) and stable disease (SD))
- Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19TNF.
- Characterization of pharmacokinetics (PK) of L19TNF and doxorubicin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, phase 1 dose confirmation study in patients with advanced, unresectable and/or metastatic soft tissue sarcoma
| Arm | Type | Receives |
|---|---|---|
| Arm L19TNF + DOXO | Experimental | Drug: L19TNF, Drug: DOXORUBICINPatients will be treated with: * doxorubicin 75 mg/m2 i.v. on day 1 of each 21-day cycle; * L19TNF 13 µg/kg i.v. on day 1, 3 and 5 of each 21-day cycle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-85 years.
- Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Note: Evidence of disease progression is required for participants that are not newly diagnosed.
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. If only one lesion is present at screening this lesion should not have been irradiated during previous treatments.
- Life expectancy of at least 3 months in the judgment of the investigator.
- ECOG ≤ 2.
Key exclusion criteria (32 listed)
- Diagnosis of GIST or Kaposi sarcoma.
- Prior therapy (except surgery and radiation) for this presentation of unresectable or metastatic malignant soft tissue sarcoma.
- Previous treatment with anthracycline- or anthracenedione-containing chemotherapy.
- Radiotherapy within 3 weeks (21 days) prior to therapy and previous radiation therapy to the mediastinal or pericardial area.
- Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis). Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before randomization to rule out brain metastasis.
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 |
|---|---|---|
| L19TNFL19TNF 13 µg/kg i.v. will be administered on day 1, 3 and 5 of each 21-day cycle | Drug | Arm L19TNF + DOXO |
| DOXORUBICINDoxorubicin 75 mg/m2 will be administered on day 1 of each 21-day cycle | Drug | Arm L19TNF + DOXO |
Primary outcome
Number and type of Adverse events (AE)
Time frame: From week 1 to week 72
Adverse event (AE) for the assessment of safety (CTCAE v. 5.0)
Number and type of Serious Adverse events (SAE)
Time frame: From week 1 to week 72
Serious Adverse Events (SAE) for the assessment of safety (CTCAE v. 5.0)
Number and type of Drug induced liver injury (DILI)
Time frame: From week 1 to week 72
Drug induced liver injury (DILI) assessment based on CTCAE v.5.0
Electrocardiogram (ECG) findings
Time frame: From week 1 to week 72
Electrocardiogram (ECG) findings. In particular, data about QT/QTc intervals will be collected and analyzed for QT/QTc prolongation potentially caused by treatment.
Echocardiogram (ECHO) findings
Time frame: From week 1 to week 72
Echocardiogram (ECHO) findings. In particular, data about QT/QTc intervals will be collected and analyzed for QT/QTc prolongation potentially caused by treatment.
Calculation of the body surface area (BSA)
Time frame: From week 1 to week 72
BSA
Measurement of body weight
Time frame: From week 1 to week 72
Measurement of body weight
Heart rate
Time frame: From week 1 to week 72
Measurement of heart rate
Blood pressure
Time frame: From week 1 to week 72
Measurement of blood pressure
ECOG performance status
Time frame: From week 1 to week 72
6 secondary outcomes
Progression-free survival (PFS) rate
Time frame: 3, 6, 9, 12 and 18 months
Efficacy of L19TNF in combination with doxorubicin: Overall response rate
Time frame: 3, 6, 9, 12 and 18 months
Efficacy of L19TNF in combination with doxorubicin: Disease Control Rate
Time frame: 3, 6, 9, 12 and 18 months
HAFA measurement
Time frame: Treatment phase: at day 1 of cycle 1, at day 8 of week 1, at day 1 of cycle 2 and at day 1 of every cycle; at day 1 of every maintenance cycle (each cycle is 21 days)
PK value of L19TNF
Time frame: Cycle 1 day 1, Cycle 1 day 2, cycle 1 day 3 and cycle 1 day 5 (each cycle is 21 days)
PK value of doxorubicin
Time frame: Cycle 1 day 1, Cycle 1 day 2, cycle 1 day 3 and cycle 1 day 5 (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 L19TNF and DOXORUBICIN in people with Soft Tissue Sarcoma, run by Philogen S.p.A. at 1 site in United States.
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 10 inclusion and 32 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 8 Apr 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 United States. 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?
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?
Number and type of Adverse events (AE) (time frame: From week 1 to week 72). The study lists 10 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 8 Apr 2024.