CarcinomaPhase 1NCT01479023
Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors
A Phase 1 study testing 64Cu-DOTA-U3-1287 and U3-1287 (unlabeled) in people with Carcinoma and Sarcoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
2.1 Primary Objectives 1. To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only) 2. To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287 in… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- 64Cu-DOTA-U3-1287 and U3-1287 (unlabeled)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2013
- 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
- Patient must have measurable disease as defined by RECIST 1.1, with the additional requirement of at least one lesion ≥ 1.5 cm on CT scan or detectable on FDG-PET performed within 30 days prior to screening
- Patient must have a tumor where HER3 expression is expected (this includes breast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, and esophageal cancer, but other tumors will be considered based on emerging HER3 expression data)
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patient must have pathologically documented, definitively diagnosed, advanced solid tumors that are refractory to standard treatment or for which no curative therapy is available
- Patient must have adequate hematologic and organ function as follows:
- Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
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- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 2 x IULN
- AST ≤ 2.5 x IULN (≤ 5.0 x IULN if attributable to liver metastasis)
- ALT ≤ 2.5 x IULN (≤ 5.0 x IULN if attributable to liver metastasis)
- Alkaline phosphatase ≤ 2.0 x ULN (if bone or liver metastases are present, < 5 x ULN)
- Total bilirubin ≤ 1.5 IULN
- Amylase or lipase ≤ 2.0 x IULN
- Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.5 x IULN
- Patient must have an LVEF of ≥ 50%
- Patient must be ≥ 18 years old
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 6 months following the completion of study treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patient must be willing and able to undergo the imaging studies outlined in the protocol (in the opinion of the investigator)
- Patient must be able to understand and willing to sign an institutional review board (IRB) approved informed consent form
- Patient must have archival tissue available for HER3 expression analysis
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patient must not have the liver and/or spleen as the only site(s) of disease (as PET/CT imaging of 64Cu-DOTA-U3-1287 may be difficult in these anatomic locations)
- Patient must not have any unresolved toxicities > grade 1 with the exception of grade 2 lymphopenia and/or alopecia from prior anti-cancer therapy Note: Grade 2 or 3 toxicities from prior therapy that are considered irreversible (defined as having been present and stable for > 3 months), such as ifosfamide-related proteinuria, or treatment related neuropathy, may be allowed if they are not otherwise described in the exclusion criteria AND the PI and Daiichi Sankyo both agree that this patient may be included
- Patient must not have untreated or symptomatic primary central nervous system metastases or symptoms of brain metastases; any stereotactic radiation or whole brain radiation therapy must have been completed at least 4 weeks prior to study entry
- Patient must not have ascites or pleural effusion requiring medical intervention
- Patient must not have had a myocardial infarction within 6 months of Day 1 or any unstable or uncontrolled disease/condition related to or impacting cardiac function (i.e., unstable angina, congestive heart failure, New York Heart Association > class II, uncontrolled hypertension [diastolic > 95 mmHg; systolic >140 mmHg])
- Patient not have cardiac arrhythmia or clinically significant ECG abnormalities
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- Patient must not be known to be positive for human immunodeficiency virus (HIV) infection, hepatitis C virus, or chronic active hepatitis B infection
- Patient must not have a known sensitivity to any components of the formulation
- Patient must not be receiving any concomitant antitumor treatment or chemotherapy, radiotherapy, and hormonal therapy (with the exception of Lupron for prostate cancer and SERMS for breast cancer subjects) within 4 weeks of Day 1 (6 weeks for nitrosoureas or mitomycin and 2 weeks for small molecule tyrosine kinase inhibitors)
- Patient must not be receiving any concomitant immunosuppressant therapy (cyclosporine A, FK506, etc., or chronic > 5 mg/d of prednisone)
- Patient must not be receiving any other concomitant investigational procedures and must not have participated in any other clinical trial with an investigational device or agent within 4 weeks of the first dose of 64Cu-DOTA-U3-1287
- Patient must not have had any previous exposure to U3-1287
- Patient must not have had any previous treatment with HER3 antagonists
- Patient must not have had G-CSF support therapy within 2 weeks of Day 1
- Patient must not have received red blood cell (RBC) transfusion within 2 weeks of Day 1
- Patient must not have received platelet transfusion within 2 weeks of Day 1
- Patient must not be pregnant or planning to become pregnant within 6 months after the end of treatment; patient must not be breastfeeding
- Patient must not have a known sensitivity to any of the products to be administered during dosing, including excipients, radiolabeled agents
- Patient must not have had major surgery within 28 days of Day 1 or predicted need for major surgery while on study
- Patient must not schedule any elective surgeries (with the exception of port placement or replacement) during his/her participation in the study and through 28 days after the last administration of U3-1287
- Patient must not have any comorbid medical disorder that may increase the risk of toxicity in the opinion of the investigator or sponsor
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors and Determination of Tumor Receptor Occupancy by U3-1287
2.1 Primary Objectives
- To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only)
- To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5))
- To determine the safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts)
Read more
2.2 Secondary Objectives
- To determine the relationship between U3-1287 serum concentration and HER3 receptor occupancy (as measured by PET/CT) in subjects with advanced solid tumors
- To measure the tumor response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects with advanced solid tumors treated with U3-1287 (Part 2 only)
- To characterize the PK exposure of U3 1287 when administered intravenously to patients with advanced solid malignancies.
- To measure the rate of anti-U3-1287 human antibody development in subjects with advanced solid tumors treated with U3 1287 monotherapy
2.3 Exploratory Objectives
- To assess tumor volume changes after U3-1287 treatment by CT or magnetic resonance imaging (MRI) (Part 2 only)
- To assess blood, body fluid/tissue, and tumor specimens for potential biomarkers (e.g., proteins and transcripts) that predict response to U3-1287
- To obtain tumor samples for DNA extraction for analysis of potential predictors of response to U3-1287 and any related genes as suggested by emerging data
- Being tested
- 64Cu-DOTA-U3-1287, U3-1287 (unlabeled)
- Medical subject headings
- Carcinoma, Sarcoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-DOTA-U3-1287Drug
U3-1287 (unlabeled)Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 64Cu-DOTA-U3-1287 at a radiotracer dosage of 8-15 mCI and ≤ 0.2 mg of DOTA-U3-1287 on Day 1.
Patient will have option to continue to Part 2 (extension phase). Receives: Drug: 64Cu-DOTA-U3-1287; Drug: U3-1287 (unlabeled) |
| Cohort 2 | Experimental | 64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1.
9.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8.
Patient will have option to continue to Part 2 (extension phase). Receives: Drug: 64Cu-DOTA-U3-1287; Drug: U3-1287 (unlabeled) |
| Cohort 3 | Experimental | 64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1.
12.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8.
Patient will have option to continue to Part 2 (extension phase). Receives: Drug: 64Cu-DOTA-U3-1287; Drug: U3-1287 (unlabeled) |
| Cohort 3a | Experimental | 64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1.
15.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8.
Patient will have option to continue to Part 2 (extension phase). Receives: Drug: 64Cu-DOTA-U3-1287; Drug: U3-1287 (unlabeled) |
| Cohort 4 | Experimental | 64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1.
18.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8.
Patient will have option to continue to Part 2 (extension phase). Receives: Drug: 64Cu-DOTA-U3-1287; Drug: U3-1287 (unlabeled) |
| Cohort 5 | Experimental | 64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1.
TBD (to be determined) mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8.
Patient will have option to continue to Part 2 (extension phase). Receives: Drug: 64Cu-DOTA-U3-1287; Drug: U3-1287 (unlabeled) |
| Part 2 (extension phase) | Experimental | Loading dose of 18.0 mg/kg unlabeled U3-1287 followed by 9.0 mg/kg unlabeled U3-1287 every 3 weeks. Receives: Drug: 64Cu-DOTA-U3-1287; Drug: U3-1287 (unlabeled) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only)
Measurement of the human dosimetry at 3 hours post dose, 24 hours post dose and 48 hours post dose.
Measured: 2 days
HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5))
Calculation of HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287
Measured: 9 days
Safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts)
Based on adverse events according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: From first receiving study treatment until the 8-week follow-up after the conclusion of treatment or death
Secondary outcomes (4)
Relationship between U3-1287 serum concentration and HER3 receptor occupancy in subjects with advanced solid tumors
Measured by PET/CT at 24 hours post dose Day 1 and 24 hours post dose Day 8
Measured: 9 days
Tumor response rate in subjects with advanced solid tumors treated with U3-1287 (Part 2 only)
Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1. Screening, after two dose (6 weeks) of U3-1287 during Part 2, and every 9 weeks thereafter.
Measured: Followed for 8 weeks following last administration of study or until death, whichever occurs first
PK exposure of U3-1287 when administered intravenously to patients with advanced solid malignancies.
Cohort 1 Part 1 = Day 1 predose, end of infusion, hour 3, 24 hours, 48 hours, and 72 hours.
Cohort 1 Part 2 = Day 8 predose, 5 minutes pre-end of infusion, hour 6, day 9, day 15, day 22, and then every 3 weeks.
Cohorts 2-5 Part 1 = Day 1 predose, end of infusion, 24 hours, Day 8 predose, end of infusion, and Day 9.
Cohorts 2-5 Part 2 = Day 29 predose, end of infusion, Day 30, and every 3 weeks.
Measured: Various timepoints depending on cohort
Rate of anti-U3-1287 human antibody development in subjects with advanced solid tumors treated with U3-1287 monotherapy
Pre-infusion on Day 1 of every cycle and end of study treatment visit.
For patients positive for anti-U3-1287 neutralizing antibody on the serum sample drawn at the final visit, additional serum samples should be obtained until the level returns to baseline (or becomes negative) or up to 1 year from the last dose of study drug or if the patient starts another therapy for his/her cancer, whichever occurs first.
Measured: Up to 1 year from the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionMar 2013
Why it stopped: treatment was not working
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. Craig Lockhart, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479023
- Sponsor's protocol ID
- 201202074
- Status last verified
- Dec 2013
- First submitted
- 17 Nov 2011
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lockhart AC, Liu Y, Dehdashti F, Laforest R, Picus J, Frye J, Trull L, Belanger S, Desai M, Mahmood S, Mendell J, Welch MJ, Siegel BA. Phase 1 Evaluation of [(64)Cu]DOTA-Patritumab to Assess Dosimetry, Apparent Receptor Occupancy, and Safety in Subjects with Advanced Solid Tumors. Mol Imaging Biol. 2016 Jun;18(3):446-53. doi: 10.1007/s11307-015-0912-y.
PubMed 26567113
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors and Determination of Tumor Receptor Occupancy by U3-1287
- ClinicalTrials.gov ID
- NCT01479023
- Acronym / sponsor ID
- 201202074
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: treatment was not working
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Nov 2011 (estimated)
- 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.
2.1 Primary Objectives
- To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only)
- To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5))
- To determine the safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts)
2.2 Secondary Objectives
- To determine the relationship between U3-1287 serum concentration and HER3 receptor occupancy (as measured by PET/CT) in subjects with advanced solid tumors
- To measure the tumor response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects with advanced solid tumors treated with U3-1287 (Part 2 only)
- To characterize the PK exposure of U3 1287 when administered intravenously to patients with advanced solid malignancies.
- To measure the rate of anti-U3-1287 human antibody development in subjects with advanced solid tumors treated with U3 1287 monotherapy
2.3 Exploratory Objectives
- To assess tumor volume changes after U3-1287 treatment by CT or magnetic resonance imaging (MRI) (Part 2 only)
- To assess blood, body fluid/tissue, and tumor specimens for potential biomarkers (e.g., proteins and transcripts) that predict response to U3-1287
- To obtain tumor samples for DNA extraction for analysis of potential predictors of response to U3-1287 and any related genes as suggested by emerging data
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 64Cu-DOTA-U3-1287, Drug: U3-1287 (unlabeled)64Cu-DOTA-U3-1287 at a radiotracer dosage of 8-15 mCI and ≤ 0.2 mg of DOTA-U3-1287 on Day 1. Patient will have option to continue to Part 2 (extension phase). |
| Cohort 2 | Experimental | Drug: 64Cu-DOTA-U3-1287, Drug: U3-1287 (unlabeled)64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1. 9.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8. Patient will have option to continue to Part 2 (extension phase). |
| Cohort 3 | Experimental | Drug: 64Cu-DOTA-U3-1287, Drug: U3-1287 (unlabeled)64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1. 12.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8. Patient will have option to continue to Part 2 (extension phase). |
| Cohort 3a | Experimental | Drug: 64Cu-DOTA-U3-1287, Drug: U3-1287 (unlabeled)64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1. 15.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8. Patient will have option to continue to Part 2 (extension phase). |
| Cohort 4 | Experimental | Drug: 64Cu-DOTA-U3-1287, Drug: U3-1287 (unlabeled)64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1. 18.0 mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8. Patient will have option to continue to Part 2 (extension phase). |
| Cohort 5 | Experimental | Drug: 64Cu-DOTA-U3-1287, Drug: U3-1287 (unlabeled)64Cu-DOTA-U3-1287 at the radiotracer dosage defined by Cohort 1 and ≤ 0.2 mg of DOTA-U3-1287 on Day 1. TBD (to be determined) mg/kg unlabeled U3-1287 followed by a second dose of ≤ 0.2 mg 64Cu-DOTA-U3-1287 on Day 8. Patient will have option to continue to Part 2 (extension phase). |
| Part 2 (extension phase) | Experimental | Drug: 64Cu-DOTA-U3-1287, Drug: U3-1287 (unlabeled)Loading dose of 18.0 mg/kg unlabeled U3-1287 followed by 9.0 mg/kg unlabeled U3-1287 every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patient must have measurable disease as defined by RECIST 1.1, with the additional requirement of at least one lesion ≥ 1.5 cm on CT scan or detectable on FDG-PET performed within 30 days prior to screening
- Patient must have a tumor where HER3 expression is expected (this includes breast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, and esophageal cancer, but other tumors will be considered based on emerging HER3 expression data)
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patient must have pathologically documented, definitively diagnosed, advanced solid tumors that are refractory to standard treatment or for which no curative therapy is available
- Patient must have adequate hematologic and organ function as follows:
Key exclusion criteria (21 listed)
- Patient must not have the liver and/or spleen as the only site(s) of disease (as PET/CT imaging of 64Cu-DOTA-U3-1287 may be difficult in these anatomic locations)
- Patient must not have any unresolved toxicities > grade 1 with the exception of grade 2 lymphopenia and/or alopecia from prior anti-cancer therapy Note: Grade 2 or 3 toxicities from prior therapy that are considered irreversible (defined as having been present and stable for > 3 months), such as ifosfamide-related proteinuria, or treatment related neuropathy, may be allowed if they are not otherwise described in the exclusion criteria AND the PI and Daiichi Sankyo both agree that this patient may be included
- Patient must not have untreated or symptomatic primary central nervous system metastases or symptoms of brain metastases; any stereotactic radiation or whole brain radiation therapy must have been completed at least 4 weeks prior to study entry
- Patient must not have ascites or pleural effusion requiring medical intervention
- Patient must not have had a myocardial infarction within 6 months of Day 1 or any unstable or uncontrolled disease/condition related to or impacting cardiac function (i.e., unstable angina, congestive heart failure, New York Heart Association > class II, uncontrolled hypertension [diastolic > 95 mmHg; systolic >140 mmHg])
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 |
|---|---|---|
| 64Cu-DOTA-U3-1287 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 3a, Cohort 4, Cohort 5, Part 2 (extension phase) |
| U3-1287 (unlabeled) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 3a, Cohort 4, Cohort 5, Part 2 (extension phase) |
Primary outcome
Human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only)
Time frame: 2 days
Measurement of the human dosimetry at 3 hours post dose, 24 hours post dose and 48 hours post dose.
HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5))
Time frame: 9 days
Calculation of HER3 receptor occupancy (via quantification of the tumor-localized PET signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled U3-1287
Safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts)
Time frame: From first receiving study treatment until the 8-week follow-up after the conclusion of treatment or death
Based on adverse events according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
4 secondary outcomes
Relationship between U3-1287 serum concentration and HER3 receptor occupancy in subjects with advanced solid tumors
Time frame: 9 days
Tumor response rate in subjects with advanced solid tumors treated with U3-1287 (Part 2 only)
Time frame: Followed for 8 weeks following last administration of study or until death, whichever occurs first
PK exposure of U3-1287 when administered intravenously to patients with advanced solid malignancies.
Time frame: Various timepoints depending on cohort
Rate of anti-U3-1287 human antibody development in subjects with advanced solid tumors treated with U3-1287 monotherapy
Time frame: Up to 1 year from the last dose of study drug
Results and safety
The study was stopped early (reason given: treatment was not working). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Derived from this study: PubMed 26567113Lockhart AC, Liu Y, Dehdashti F, Laforest R, Picus J, Frye J, Trull L, Belanger S, Desai M, Mahmood S, Mendell J, Welch MJ, Siegel BA. Phase 1 Evaluation of [(64)Cu]DOTA-Patritumab to Assess Dosimetry, Apparent Receptor Occupancy, and Safety in Subjects with Advanced Solid Tumors. Mol Imaging Biol. 2016 Jun;18(3):446-53. doi: 10.1007/s11307-015-0912-y.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
A. Craig Lockhart, M.D. principal investigator
Washington University School of Medicine
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 64Cu-DOTA-U3-1287 and U3-1287 (unlabeled) in people with Carcinoma and Sarcoma, run by Washington University School of Medicine 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 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: stopped early, as of the sponsor's last update on 20 Dec 2013. 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?
The study was stopped early (reason given: treatment was not working). 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?
Human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid tumors (Cohort 1 only) (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01479023, which also lists 1 linked publication.
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 20 Dec 2013.