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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44CA239461-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).
This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one androgen signaling inhibitor, followed by a dose expansion to further evaluate the safety, tolerability, efficacy and biological activity of CTT1403. CTT1403 is a PSMA-targeted 177Lu-labeled radiotherapy being developed for prostate cancer with a unique PSMA binding scaffold and an albumin binding moiety to extend circulation half-life. The PSMA binding scaffold is shared with CTT1057, a PSMA-specific PET diagnostic imaging agent shown in Phase 1 clinical trials to be specifically taken up by PSMA+ tumor. PSMA PET imaging by CTT1057 will be used diagnostically to select patients with PSMA-avid disease for treatment. The purpose of this study is to identify the dose limiting toxicity and recommended phase 2 dose of CTT1403. Eligible participants with demonstrated therapeutic benefit will be offered a second dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Escalating doses of 0.75 GBq - 2.0 GBq of CTT1403 |
|
| Dose Escalation/Expansion | Experimental | Escalating doses of 3.0 GBq - 9.0 GBq of CTT1403 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTT1403 | Drug | Escalating doses of 0.75 GBq - 9.0 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403 | The dose-limiting toxicity was defined as any of the following:
| 6-8 weeks from time of injection on Cycle 1 - Day 1 |
| Objective Response Rate by RECIST v1.1 Criteria | Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response. | Cycle 1-Day 35, Cycle 2-Day 35, 30 Days After Last Dose, 8 Weeks Post-Treatment. Each cycle lasted 35 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging | Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time. |
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Inclusion Criteria:
Exclusion Criteria:
Prostate cancer is a disease only occurring in males.
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Langton-Webster, PhD | Cancer Targeted Technology | Study Chair |
| Rahul Aggarwal, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 9410794143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.75 GBq Cohort | 0.75 GBq dose of CTT1403 |
| FG001 | 1.5 GBq Cohort | 1.5 GBq dose of CTT1403 |
| FG002 | 2.0 GBq Cohort | 2.0 GBq dose of CTT1403 |
| FG003 | 3.0 GBq Cohort | 3.0 GBq dose of CTT1403 |
| FG004 | 4.5 GBq Cohort | 4.5 GBq dose of CTT1403 |
| FG005 | 6.0 GBq Cohort | 6.0 GBq dose of CTT1403 |
| FG006 | 7.5 GBq Cohort | 7.5 GBq dose of CTT1403 |
| FG007 | 9.0 GBq Cohort | 9.0 GBq dose of CTT1403 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.75 GBq Cohort | 0.75 GBq dose of CTT1403 |
| BG001 | 1.5 GBq Cohort | 1.5 GBq dose of CTT1403 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403 | The dose-limiting toxicity was defined as any of the following:
| Posted | Count of Participants | Participants | 6-8 weeks from time of injection on Cycle 1 - Day 1 |
|
Information on adverse events was collected throughout the course of the study and up to 6 months after the last administered dose of the study drug, up to a total of 7 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.75 GBq Cohort | 0.75 GBq dose of CTT1403 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 Fall | General disorders | Systematic Assessment | Unrelated to study drug. Met reporting criteria per protocol due to hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
The highest administered dose of CTT1403 was 9.0 GBq. At the 9.0 GBq dose, patients had to remain in-patient (in hospital) after administration due to continued radioactivity and for the safety of others until radioactivity dropped to an acceptable level as deemed by the hospital radiation safety committee.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beatrice Langton-Webster, CEO | Cancer Targeted Technology | (206) 617-0699 | bealw@cancertargetedtechnology.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2021 | Apr 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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|
| CTT1057 | Drug | Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403. |
|
| 68Ga-PSMA-11 | Drug | Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403. |
|
| 2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1 |
| Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index | The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable. | Cycle 1-Day 1 and Cycle 2-Day 1. Each cycle lasted 35 days. |
| Assessment of Pharmacokinetics of CTT1403 | The distribution half-life and the elimination half-life of CTT1403 were calculated. | Samples were collected during Cycle 1 (timepoints start at the initiation of infusion): Day 1 (30 min +/- 5 min and 2 hrs +/- 30 min), Day 2 (24 hrs +/- 12 hrs), Day 3 (48 hrs +/- 12 hrs), Day 8 (168 hrs +/- 24 hrs), Day 15 (336 hrs +/- 24 hrs) |
| BG002 |
| 2.0 GBq Cohort |
2.0GBq dose of CTT1403 |
| BG003 | 3.0 GBq Cohort | 3.0 GBq dose of CTT1403 |
| BG004 | 4.5 GBq Cohort | 4.5 GBq dose of CTT1403 |
| BG005 | 6.0 GBq Cohort | 6.0 GBq dose of CTT1403 |
| BG006 | 7.5 GBq Cohort | 7.5 GBq dose of CTT1403 |
| BG007 | 9.0 GBq Cohort | 9.0 GBq dose of CTT1403 |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
0.75 GBq dose of CTT1043 |
| OG001 | 1.5 GBq Cohort | 1.5 GBq dose of CTT1043 |
| OG002 | 2.0 GBq Cohort | 2.0 GBq dose of CTT1043 |
| OG003 | 3.0 GBq Cohort | 3.0 GBq dose of CTT1043 |
| OG004 | 4.5 GBq Cohort | 4.5 GBq dose of CTT1043 |
| OG005 | 6.0 GBq Cohort | 6.0 GBq dose of CTT1043 |
| OG006 | 7.5 GBq Cohort | 7.5 GBq dose of CTT1043 |
| OG007 | 9.0 GBq Cohort | 9.0 GBq dose of CTT1043 |
|
|
| Primary | Objective Response Rate by RECIST v1.1 Criteria | Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response. | In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew. | Posted | Count of Participants | Participants | Cycle 1-Day 35, Cycle 2-Day 35, 30 Days After Last Dose, 8 Weeks Post-Treatment. Each cycle lasted 35 days. |
|
|
|
| Secondary | Assessment of Organ Dosimetry of CTT1403 by SPECT/CT Imaging | Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time. | Posted | Mean | Standard Deviation | Gy/GBq | 2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1 |
|
|
|
| Secondary | Number of Participants With Change in Patient Reported Pain as Measured by Brief Pain Index | The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable. | In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew. | Posted | Count of Participants | Participants | Cycle 1-Day 1 and Cycle 2-Day 1. Each cycle lasted 35 days. |
|
|
|
| Secondary | Assessment of Pharmacokinetics of CTT1403 | The distribution half-life and the elimination half-life of CTT1403 were calculated. | In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew. | Posted | Mean | Standard Deviation | hours | Samples were collected during Cycle 1 (timepoints start at the initiation of infusion): Day 1 (30 min +/- 5 min and 2 hrs +/- 30 min), Day 2 (24 hrs +/- 12 hrs), Day 3 (48 hrs +/- 12 hrs), Day 8 (168 hrs +/- 24 hrs), Day 15 (336 hrs +/- 24 hrs) |
|
|
|
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | 1.5 GBq Cohort | 1.5 GBq dose of CTT1403 | 1 | 1 | 0 | 1 | 1 | 1 |
| EG002 | 2.0 GBq Cohort | 2.0 GBq dose of CTT1403 | 1 | 1 | 0 | 1 | 0 | 1 |
| EG003 | 3.0 GBq Cohort | 3.0 GBq dose of CTT1403 | 3 | 3 | 0 | 3 | 2 | 3 |
| EG004 | 4.5 GBq Cohort | 4.5 GBq dose of CTT1403 | 4 | 4 | 1 | 4 | 2 | 4 |
| EG005 | 6.0 GBq Cohort | 6.0 GBq dose of CTT1403 | 3 | 3 | 1 | 3 | 2 | 3 |
| EG006 | 7.5 GBq Cohort | 7.5 GBq dose of CTT1403 | 3 | 3 | 1 | 3 | 1 | 3 |
| EG007 | 9.0 GBq Cohort | 9.0 GBq dose of CTT1403 | 1 | 1 | 0 | 1 | 1 | 1 |
|
| Grade 3 Syncope | General disorders | Systematic Assessment | Unrelated to study drug. Met reporting criteria per protocol due to hospitalization. |
|
| Grade 3 Atrial Fibrillation with Rapid Ventricular Response | Cardiac disorders | Systematic Assessment | Unrelated to study drug. Met reporting criteria per protocol due to hospitalization. |
|
| Grade 3 Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated to study drug. Met reporting criteria per protocol due to hospitalization. |
|
| Grade 3 Hyponatremia | Blood and lymphatic system disorders | Systematic Assessment | Unrelated to study drug. Met reporting criteria per protocol due to hospitalization. |
|
| Grade 3 Cerebrovascular Accident | Nervous system disorders | Systematic Assessment | Unrelated to study drug. Met reporting criteria per protocol due to hospitalization. |
|
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Dry heave | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Abdominal malaise | General disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Decreased apetite | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Fatigue | General disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Blood in urine | Renal and urinary disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Dry eye | Eye disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Vomitting | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Diaphoresis | General disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Taste changes | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Periorbital swelling | Skin and subcutaneous tissue disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Intermittent bloating | Gastrointestinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Number of patients that experienced Grade 1 or 2 |
|
Sponsor can review results for a period that is less than or equal to 45 days prior to submission for publication or disclosure to a third party. If sponsor believes patentable subject matter is disclosed, it shall, within 30 days of receipt, notify university and publication or disclosure will be withheld for a period of up to 90 days from date of receipt or until university and sponsor agree that no patentable invention exists, whichever period is shorter.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Number of patients with progressive disease on Cycle 1-Day 35 |
|
| Number of patients with stable disease on Cycle 2-Day 35 |
|
| Number of patients with progressive disease on Cycle 2-Day 35 |
|
| Number of patients with stable disease 30 days after last dose |
|
| Number of patients with progressive disease 30 days after last dose |
|
| Number of patients with stable disease 8 weeks post-treatment |
|
| Number of patients with progressive disease 8 weeks post-treatment |
|
| Mean absorbed dose per GBq - Right Kidney |
|
| Experienced a decrease in reported pain |
|
| Experienced no change in reported pain |
|
| Change in rating of average pain from Cycle 1-Day 1 to Cycle 2-Day 1 |
|
|
| Elimination half-life |
|
|