Advanced Soft-tissue SarcomaPhase 1NCT05043649
Camsirubicin + Pegfilgrastim to Determine MTD in ASTS
A Phase 1 study testing Camsirubicin in people with Advanced Soft-tissue Sarcoma, run by Monopar Therapeutics at 2 sites in United States.
Trial summary
This is an Interventional Study in Advanced Soft Tissue Sarcomas (ASTS). It is a Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Soft-tissue Sarcoma
- What is being tested?
- Camsirubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2021to 13 May 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
- Patients must meet all of the following criteria to be eligible for inclusion in this study:
- The participant must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g., blood count, imaging tests) and obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
- Age ≥18 years.
- Only locally confirmed histological diagnosis of advanced unresectable or metastatic malignant soft tissue sarcoma (including leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, pleomorphic liposarcoma, undifferentiated pleomorphic sarcoma, malignant peripheral nerve sheath tumor, high-grade sarcoma [not otherwise specified], or synovial sarcoma) not amenable to curative treatment with surgery or radiotherapy.
- Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
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- The participant has not received any previous treatment with anthracyclines (not even in adjuvant therapy).
- The participant has not had any prior systemic cytotoxic therapies for advanced/metastatic sarcoma and is considered an appropriate candidate for anthracycline therapy. All previous anticancer treatments must be completed ≥28 days prior to first dose of study drug.
- Laboratory tests must be as follows and may be repeated once at the discretion of the investigator:
- Absolute neutrophil count (ANC) ≥1,500/mm³
- Platelet count ≥100,000/mm³
- Hemoglobin >9 g/dL
- Bilirubin <1.5 times upper limit of normal (ULN); except subjects with Gilbert Syndrome who must have a total bilirubin level <3.0 x ULN
- Prothrombin time (PT) (seconds) or international normalized ratio (INR) ≤1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN or, in patients with documented hepatic metastasis, ≤5 x ULN
- Serum creatinine ≤1.5 mg/dL or estimated creatinine clearance ≥60 mL/min (Cockroft and Gault)
- Left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to enrollment.
- Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment. A female is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, a bilateral oophorectomy (ovariectomy), a bilateral tubal ligation, or is postmenopausal with a minimum of 1 year without menses.
- Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 3 months following the last dose of study drug.
- Female patients who are lactating must agree to discontinue nursing prior to the first dose of study drug and must refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug.
- The participant has, in the opinion of the investigator, a life expectancy of at least 3 months.
Who cannot join
- Patients must not meet any of the exclusion criteria to be eligible for study participation.
- Current evidence/diagnosis of alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma (unless transformed to fibrosarcoma), Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, or clear cell sarcomas.
- Patients who cannot tolerate pegfilgrastim.
- Known active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of a CNS metastasis previously treated with curative intent (e.g., stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days prior to first dose, 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 enrollment to rule out brain metastasis.
- Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones (including adjuvant therapy).
- Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation. Other thoracic radiotherapy is permitted.
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- The participant has symptomatic congestive heart failure (CHF), left ventricular ejection fraction dysfunction (LVEF <50%), severe myocardial insufficiency, cardiac arrhythmia (uncontrolled, clinically significant), or cardiomyopathy.
- The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of enrollment.
- The participant has a QT interval calculated using Fridericia's correction (QTcF) of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG).
- Females who are pregnant or breastfeeding.
- Known allergy to any of the treatment components including a history of allergic reactions attributed to compounds of chemical or biological composition similar to doxorubicin and camsirubicin, including intravenous (IV) lactose, or pegfilgrastim.
- The participant has a known, uncontrolled active fungal, uncontrolled bacterial, or uncontrolled viral infection including human immunodeficiency virus (HIV) or viral hepatitis (B or C).
- Any malignancy other than soft tissue sarcoma within the last 5 years prior to screening, with the exception of:
- Cervical carcinoma in situ or
- Basal cell carcinoma or
- Superficial bladder tumors that have been successfully and curatively treated with no evidence of recurrent or residual disease.
- Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, confound the assessment of camsirubicin's effect, jeopardize the safety of a patient and/or their compliance with the protocol.
- Currently receiving any investigational agents.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sarcoma Oncology Center
Santa Monica, California, 90403
University of Washington Medicine Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
Official title: A Phase 1b, Open-label, Dose-escalation Clinical Study Evaluating the Safety of Camsirubicin With Prophylactic Pegfilgrastim in the Treatment of Advanced Soft Tissue Sarcomas
This is an Interventional Study in Advanced Soft Tissue Sarcomas (ASTS). It is a Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. The objective of the study is to evaluate the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of ASTS and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of camsirubicin with prophylactic pegfilgrastim. The primary endpoint is the MTD (RP2D).The secondary endpoints are: safety profile of camsirubicin with prophylactic pegfilgrastim, PFS, TTP, ORR, DoR, OS and PK. As exploratory endpoint, Quality of life will be measured by using the Functional Assessment of Cancer Therapy: General (FACT-G).
Read the detailed description
This is a Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. Following a screening period of up to 28 days, eligible patients will receive camsirubicin through intravenous (IV) infusion (8 mL/min rate) once every 21 days, starting on Day 1 of a 21-day cycle for 6 cycles. Dose will be based on the patient's body surface area (BSA). Patients who demonstrate clinical benefit (defined as stable disease or better) at the completion of 6 cycles will be allowed to continue to receive camsirubicin until disease progression or unacceptable toxicity. All patients receiving camsirubicin will also receive 6 mg of prophylactic pegfilgrastim approximately 24-96 hours after each camsirubicin infusion to prevent neutropenia. The dose escalation will start at 265 mg/m2, with dose increments for subsequent dose groups of 50% until a drug-related Grade 2 non-hematologic toxicity is observed, at which point subsequent dose escalations will be in increments of 25% until an MTD is identified.
At each successive dose level, cohorts of 3 new patients will be entered if no dose-limiting toxicity (DLT) is observed (3+3 design) within 21 days of initial dose. If a patient treated at any dose level experiences a DLT, a total of up to 6 patients will be treated at that dose level. Once two patients at any dose level experience a DLT, no additional patients will be treated at that level. The MTD is defined as the highest dose level below the dose level at which 2 or more patients experience a DLT during the first 21 days from Cycle 1 Day 1. This will be the RP2D unless safety concerns suggest a lower dose. Patients in each new cohort at all dose levels (i.e., all patients receiving their initial dose of camsirubicin at the designated dose level) will successfully complete one cycle of treatment prior to beginning treatment of the new cohort of patients at the next higher dose level.
The RP2D dose may be expanded by 6 patients to obtain additional PK and safety data at this dose. Patients will be followed for adverse events of special interest (AESI), which include the incidence of congestive heart failure (CHF) and left ventricular ejection fraction (LVEF) dysfunction. Patients will be followed for 1 year post last dose and AESI assessed every 3 months. Assessments will include LVEF assessment by echocardiogram or multi-gated radionuclide angiography (MUGA) scan and measurement of Troponin-I. LVEF assessments should be collected even if the patient will go on to other anticancer therapies during the 1-year post last dose long-term follow-up period. If cardiac toxicity is suspected, an echocardiogram should be performed sooner if a patient develops signs and symptoms of congestive heart failure (e.g., shortness of breath during mild exertion or when lying down, feel very tired, cough (especially at night), swelling of the feet and/or ankles).
Patients with serious adverse events (SAEs) or AESI assessed by the investigator during the 1-year follow-up period as related to study medications will be followed until the AE completely resolves or is assessed as chronic. Unresolved SAE or AESI at the end of the 1-year long-term follow-up period will be followed for status for up to 2 years at approximately 3-month intervals.
- Conditions
- Advanced Soft-tissue Sarcoma
- Being tested
- Camsirubicin
- Keywords
- Sarcoma, ASTS, Soft Tissue Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamsirubicinDrug
The dose escalation of camsirubicin will start at 265 mg/m2, with dose increments of 50% until a Grade 2 non-hematologic toxicity is observed at which point subsequent dose escalations will be in increments of 25% until an MTD is identified in patients with ASTS.
| Study group | Role | What they receive |
|---|---|---|
| Camsirubicin + pegfilgrastim | Experimental | Camsirubicin phase 1b dose escalating to determine MTD Receives: Drug: Camsirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine Maximum Tolerated Dose (MTD)
Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) will be collected for all treated subjects at each dose level of camsirubicin to identify dose limiting toxicities (DLTs). At each successive dose level, cohorts of 3 new patients will be entered if no dose limiting toxicity (DLT) is observed (3+3 design) within 21 days of initial dose. If a patient treated at any dose level experiences a DLT, a total of up to 6 patients will be treated at that dose level. Once two patients at any dose level experience a DLT, no additional patients will be treated at that level. The MTD will be defined as the highest dose level below the dose level at which 2 or more patients experience a DLT during the first 21 days from Cycle 1 Day 1.
Measured: 3 weeks after first injection
Recommended Phase 2 Dose (RP2D) Camsirubicin HCl for Injection
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the safety expansion cohort, based on safety, tolerability, efficacy, PK, and MTD data collected during the dose escalation portion of the study.
Measured: Up to 1 year after the first dose
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety]
Safety profile of camsirubicin with prophylactic pegfilgrastim, through assessment of adverse event (AE) type, incidence, severity, time of appearance, and related causes (detected by physical explorations and laboratory tests). Adverse events will be graded and tabulated using NCI CTCAE v5.0.
Measured: Up to 1 year after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start22 Sep 2021
- Primary completion31 Oct 2023
- Study completion13 May 2024
Why it stopped: lack of timely enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Soft-tissue SarcomaStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monopar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holli Carlson, Study director, Monopar Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043649
- Sponsor's protocol ID
- MNPR-201-001
- Status last verified
- May 2024
- First submitted
- 31 Aug 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Dose-escalation Clinical Study Evaluating the Safety of Camsirubicin With Prophylactic Pegfilgrastim in the Treatment of Advanced Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT05043649
- Acronym / sponsor ID
- MNPR-201-001
- Conditions
- Advanced Soft-tissue Sarcoma
- Keywords
- Sarcoma, ASTS, Soft Tissue Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of timely enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Monopar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 14 Sep 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 is an Interventional Study in Advanced Soft Tissue Sarcomas (ASTS). It is a Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. The objective of the study is to evaluate the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of ASTS and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of camsirubicin with prophylactic pegfilgrastim. The primary endpoint is the MTD (RP2D).The secondary endpoints are: safety profile of camsirubicin with prophylactic pegfilgrastim, PFS, TTP, ORR, DoR, OS and PK. As exploratory endpoint, Quality of life will be measured by using the Functional Assessment of Cancer Therapy: General (FACT-G).
Detailed description
This is a Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. Following a screening period of up to 28 days, eligible patients will receive camsirubicin through intravenous (IV) infusion (8 mL/min rate) once every 21 days, starting on Day 1 of a 21-day cycle for 6 cycles. Dose will be based on the patient's body surface area (BSA). Patients who demonstrate clinical benefit (defined as stable disease or better) at the completion of 6 cycles will be allowed to continue to receive camsirubicin until disease progression or unacceptable toxicity. All patients receiving camsirubicin will also receive 6 mg of prophylactic pegfilgrastim approximately 24-96 hours after each camsirubicin infusion to prevent neutropenia. The dose escalation will start at 265 mg/m2, with dose increments for subsequent dose groups of 50% until a drug-related Grade 2 non-hematologic toxicity is observed, at which point subsequent dose escalations will be in increments of 25% until an MTD is identified.
At each successive dose level, cohorts of 3 new patients will be entered if no dose-limiting toxicity (DLT) is observed (3+3 design) within 21 days of initial dose. If a patient treated at any dose level experiences a DLT, a total of up to 6 patients will be treated at that dose level. Once two patients at any dose level experience a DLT, no additional patients will be treated at that level. The MTD is defined as the highest dose level below the dose level at which 2 or more patients experience a DLT during the first 21 days from Cycle 1 Day 1. This will be the RP2D unless safety concerns suggest a lower dose. Patients in each new cohort at all dose levels (i.e., all patients receiving their initial dose of camsirubicin at the designated dose level) will successfully complete one cycle of treatment prior to beginning treatment of the new cohort of patients at the next higher dose level.
The RP2D dose may be expanded by 6 patients to obtain additional PK and safety data at this dose. Patients will be followed for adverse events of special interest (AESI), which include the incidence of congestive heart failure (CHF) and left ventricular ejection fraction (LVEF) dysfunction. Patients will be followed for 1 year post last dose and AESI assessed every 3 months. Assessments will include LVEF assessment by echocardiogram or multi-gated radionuclide angiography (MUGA) scan and measurement of Troponin-I. LVEF assessments should be collected even if the patient will go on to other anticancer therapies during the 1-year post last dose long-term follow-up period. If cardiac toxicity is suspected, an echocardiogram should be performed sooner if a patient develops signs and symptoms of congestive heart failure (e.g., shortness of breath during mild exertion or when lying down, feel very tired, cough (especially at night), swelling of the feet and/or ankles).
Patients with serious adverse events (SAEs) or AESI assessed by the investigator during the 1-year follow-up period as related to study medications will be followed until the AE completely resolves or is assessed as chronic. Unresolved SAE or AESI at the end of the 1-year long-term follow-up period will be followed for status for up to 2 years at approximately 3-month intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camsirubicin + pegfilgrastim | Experimental | Drug: CamsirubicinCamsirubicin phase 1b dose escalating to determine MTD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must meet all of the following criteria to be eligible for inclusion in this study:
- The participant must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g., blood count, imaging tests) and obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
- Age ≥18 years.
- Only locally confirmed histological diagnosis of advanced unresectable or metastatic malignant soft tissue sarcoma (including leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, pleomorphic liposarcoma, undifferentiated pleomorphic sarcoma, malignant peripheral nerve sheath tumor, high-grade sarcoma [not otherwise specified], or synovial sarcoma) not amenable to curative treatment with surgery or radiotherapy.
- Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Key exclusion criteria (18 listed)
- Patients must not meet any of the exclusion criteria to be eligible for study participation.
- Current evidence/diagnosis of alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma (unless transformed to fibrosarcoma), Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, or clear cell sarcomas.
- Patients who cannot tolerate pegfilgrastim.
- Known active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of a CNS metastasis previously treated with curative intent (e.g., stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days prior to first dose, 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 enrollment to rule out brain metastasis.
- Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones (including adjuvant therapy).
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 |
|---|---|---|
| CamsirubicinThe dose escalation of camsirubicin will start at 265 mg/m2, with dose increments of 50% until a Grade 2 non-hematologic toxicity is observed at which point subsequent dose escalations will be in increments of 25% until an MTD is identified in patients with ASTS. | Drug | Camsirubicin + pegfilgrastim |
Primary outcome
To determine Maximum Tolerated Dose (MTD)
Time frame: 3 weeks after first injection
Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) will be collected for all treated subjects at each dose level of camsirubicin to identify dose limiting toxicities (DLTs). At each successive dose level, cohorts of 3 new patients will be entered if no dose limiting toxicity (DLT) is observed (3+3 design) within 21 days of initial dose. If a patient treated at any dose level experiences a DLT, a total of up to 6 patients will be treated at that dose level. Once two patients at any dose level experience a DLT, no additional patients will be treated at that level. The MTD will be defined as the highest dose level below the dose level at which 2 or more patients experience a DLT during the first 21 days from Cycle 1 Day 1.
Recommended Phase 2 Dose (RP2D) Camsirubicin HCl for Injection
Time frame: Up to 1 year after the first dose
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the safety expansion cohort, based on safety, tolerability, efficacy, PK, and MTD data collected during the dose escalation portion of the study.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: Up to 1 year after the first dose
Results and safety
The study was stopped early (reason given: lack of timely enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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.
Holli Carlson study director
Monopar Therapeutics Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Camsirubicin in people with Advanced Soft-tissue Sarcoma, run by Monopar Therapeutics at 2 sites 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 21 inclusion and 18 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: lack of timely enrollment). 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?
To determine Maximum Tolerated Dose (MTD) (time frame: 3 weeks after first injection). 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 16 May 2024.