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| ID | Type | Description | Link |
|---|---|---|---|
| HM2015-39 | Other Identifier | University of Minnesota Masonic Cancer Center |
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Development of GTB-3550 halted due to development of the second generation camelid nanobody TriKE drug product, GTB-3650.
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This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. The hypothesis is that GTB-3550 TriKE® will induce natural killer cell function by targeting malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to tumor induced immunosuppression. Because CD16 is the most potent activating receptor on natural killer (NK) cells, this single agent may induce a targeted anti-CD33+ tumor response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | Experimental | Patients receive a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Each block consists of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment is given as an inpatient. The assigned dose will be calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose is not be recalculated for subsequent treatment blocks. |
|
| GTB-3550 TriKE® Only (Phase II: Extended Component) | Experimental | The treatment schedule is identical to the dose finding component. The extended component uses a Simon's MiniMax two-stage design for continued enrollment using the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTB-3550 TriKE® Phase I | Drug | The 1st two patients will be assigned Dose Level 1. The study statistician will assign each new cohort of 2 patients to the most appropriate dose level based on updated toxicity probabilities.
|
| Measure | Description | Time Frame |
|---|---|---|
| GTB-3550 Dosing Summary | The study was terminated prior to reaching the maximal tolerated dose. This outcome measure presents information regarding the number of participants receiving each dose of GTB-3550. | Day 1 (start of GTB-3550 therapy) |
| GTB-3550 Extent of Treatment (Summary) | This outcome measure summarizes the number of GTB-3550 treatment blocks participants received during the first cycle of treatment. | Day 28 relative to the start of GTB-3550 therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | The number of unexpected events in relation to GTB-3550 TriKE®. TEAEs were measured up to Day 28 relative to GTB-3550 therapy. | Day 28 relative to the start of GTB-3550 therapy |
| Overall Survival (OS) |
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Inclusion Criteria: Eligible Diseases
Diagnosis of one of the following CD33-expressing myeloid malignancies with greater than or equal to 50% CD33+ target cells with no good standard of care treatment options including:
High Risk Myelodysplastic Syndromes (MDS) progressive on two or more prior regimens and requiring treatment that meets at least one of the following:
Therapy related MDS and not a candidate for induction chemotherapy or had an inadequate treatment response after induction chemotherapy.
Refractory or Relapsed Acute Myelogenous Leukemia (AML) meeting at least one of the following:
Refractory AML defined as failure to achieve remission after at least 3 induction attempts
** Elderly AML not fit for induction therapy can be enrolled after 2 failed inductions
Relapsed AML
Advanced systemic mastocytosis (defined as mast cell leukemia, aggressive systemic mastocytosis, and systemic mastocytosis associated with hematologic neoplasm) may enroll without any prior treatment, given there is no standard established therapy.
Inclusion Criteria: Age, Performance Status, Organ Function, Contraception Use
At least 18 years of age
Karnofsky score ≥ 70%
Adequate organ function within 14 days (30 days for cardiac and pulmonary) of study enrollment defined as:
Absolute lymphocyte count (ALC) ≥ 200 cells/mm³ OR absolute circulating CD56+/CD3- NK cell count >25 cells/μl within the 14 days prior to start of therapy
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
Participant provides voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mark B Juckett, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| University of Wisconsin Clinical Science Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day | Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cohort 1: Dose Level 1: 5 ug/kg/Day |
|
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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 | Jun 4, 2021 |
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|
|
| GTB-3550 TriKE® Phase II | Drug | Patients will receive the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity. |
|
|
Number of patients surviving at 6 months post-treatment on this study. |
| 6 Months |
| Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | Blast count was measured at the time of standard of care disease assessment after GTB-3550 therapy. Blast percent was assessed by morphology and/or flow cytometry. | After Day 28 Relative to GTB-3550 Therapy |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| FG001 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks. |
| FG002 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks. |
| FG003 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks. |
| FG004 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks. |
| FG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks. |
| COMPLETED |
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| NOT COMPLETED |
|
| Cohort 2: Dose Level 2: 10ug/kg/Day |
|
| Cohort 3: Dose Level 3: 25 ug/kg/Day |
|
| Cohort 4: Dose Level 4: 50 ug/kg/Day |
|
| Cohort 5: Dose Level 5: 100 ug/kg/Day |
|
|
| Cohort 6: Dose Level 6: 150 ug/kg/Day |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks. |
| BG001 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks. |
| BG002 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks. |
| BG003 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks. |
| BG004 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. |
| BG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| 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 |
| ||||||||||||||||
| Baseline Disease | Count of Participants | Participants |
| ||||||||||||||||
| Number of Prior Lines of Cancer Therapy | The number of prior lines of cancer therapies include therapies to treat any cancer diagnosis. | Count of Participants | Participants |
|
| 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 | GTB-3550 Dosing Summary | The study was terminated prior to reaching the maximal tolerated dose. This outcome measure presents information regarding the number of participants receiving each dose of GTB-3550. | Posted | Count of Participants | Participants | Day 1 (start of GTB-3550 therapy) |
|
|
| |||||||||||||||||||||||||||||||
| Primary | GTB-3550 Extent of Treatment (Summary) | This outcome measure summarizes the number of GTB-3550 treatment blocks participants received during the first cycle of treatment. | Posted | Count of Participants | Participants | Day 28 relative to the start of GTB-3550 therapy |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | The number of unexpected events in relation to GTB-3550 TriKE®. TEAEs were measured up to Day 28 relative to GTB-3550 therapy. | Posted | Number | Events | Day 28 relative to the start of GTB-3550 therapy | TEAEs Regardless of Relationship | TEAEs Regardless of Relationship |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Number of patients surviving at 6 months post-treatment on this study. | Posted | Number | participants | 6 Months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | Blast count was measured at the time of standard of care disease assessment after GTB-3550 therapy. Blast percent was assessed by morphology and/or flow cytometry. | Posted | Number | participants | After Day 28 Relative to GTB-3550 Therapy |
| |||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy | Participants with lack of disease progression or evidence of a clinical improvement had the opportunity to receive an optional 2nd cycle of therapy ('retreatment'). | Posted | Number | participants | 2-4 weeks after completion of the 1st cycle of therapy |
|
Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
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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 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks. | 1 | 2 | 0 | 2 | 2 | 2 |
| EG001 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks. | 2 | 2 | 0 | 2 | 2 | 2 |
| EG002 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG003 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks. | 1 | 2 | 0 | 2 | 2 | 2 |
| EG004 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. | 2 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | All Grade 3; 2 possibly related to GTB-3550 |
|
| Lung Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment | Grade 3; Unlikely related to GTB-3550 |
|
| Skin Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment | Grade 3; Unrelated to GTB-3550 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 count: 5 (2 possibly related to GTB-3550) Grade 3 count: 14 (5 possibly related to GTB-3550) |
|
| LDH Increase | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| C-reactive protein increase | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Possibly related to GTB-3550) |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | Grade 3 Count: 10 (6 possibly related to GTB-3550) |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unrelated to GTB-3550) |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 15 (9 possibly and 1 probably related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550) |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 Grade 2 Count: 1 Unrelated to GTB-3550 |
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| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 3 (1 possibly related to GTB-3550) |
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| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unrelated to GTB-3550) |
|
| Gingival bleeding/blood blister | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unlikely related to GTB-3550) |
|
| Gingival pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unrelated to GTB-3550) |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 2 Grade 1 Count: 1 Unrelated/unlikely related to GTB-3550 |
|
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 10 (6 possibly and 3 probably related to GTB-3550) Grade 2 Count: 3 (2 possibly related to GTB-3550) |
|
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 10 (4 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550) |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 3 (1 possibly related to GTB-3550) |
|
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 13 (7 possibly and 5 probably related to GTB-3550) Grade 2 Count: 7 (2 possibly and 5 probably related to GTB-3550) Grade 3 Count: 1 (Probably related to GTB-3550) |
|
| IL-6 Increase | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) |
|
| Chloride increased | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 2 (Unlikely related to GTB-3550) |
|
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) |
|
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unrelated to GTB-3550) |
|
| Allergic reaction | Immune system disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unlikely related to GTB-3550) |
|
| Cytokine release syndrome | Immune system disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 2 (1 possibly and 1 probably related to GTB-3550) |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: Mild (Unlikely related to GTB-3550) |
|
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 4 (1 possibly related to GTB-3550) Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (2 possibly related to GTB-3550) |
|
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 5 (1 possibly and 1 probably related to GTB-3550) |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 2 (1 possibly related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 2 (2 Possibly related to GTB-3550) |
|
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 4 (1 possibly related to GTB-3550) |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 16 (4 possibly related to GTB-3550) Grade 2 Count: 6 (3 possibly related to GTB-3550) Grade 3 Count: 1 (unrelated to GTB-3550) |
|
| INR increased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (unrelated to GTB-3550) |
|
| IL-6 increase | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Possibly related to GTB-3550) |
|
| LDH elevated - intermittent | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (unrelated to GTB-3550) |
|
| Ferritin elevation | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (unrelated to GTB-3550) |
|
| CRP elevation | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 3 (1 probably related to GTB-3550) |
|
| Fibrinogen elevation | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (unrelated to GTB-3550) |
|
| Chloride increase - intermittent | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 2 (Unrelated to GTB-3550) |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 2 (2 probably related to GTB-3550) Grade 2 Count: 9 (1 possibly and 6 probably related to GTB-3550) Grade 3 Count: 10 (1 possibly and 5 possibly related to GTB-3550) Grade 4 Count: 3 (3 probably related to GTB-3550) |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 2 (2 possibly related to GTB-3550) Grade 3 Count: 2 (1 possibly related to GTB-3550) Grade 4 Count: 9 (1 possibly related to GTB-3550) |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 3 Count: 4 (unrelated to GTB-3550) Grade 4 Count: 11 (unrelated or unlikely related to GTB-3550) |
|
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Probably related to GTB-3550) Grade 2 Count: 1 (Possibly related to GTB-3550) Grade 3 Count: 7 (3 possibly related to GTB-3550) Grade 4 Count: 10 (5 possibly and 2 probably related to GTB-3550) |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550) |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 4 (Unrelated or unlikely related to GTB-3550) |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 16 (1 possibly related to GTB-3550) Grade 2 Count: 8 (Unrelated or unlikely related to GTB-3550) |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 8 (2 possibly related to GTB-3550) Grade 2 Count: 4 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unrelated to GTB-3550) |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) Grade 2 Count: 3 (1 possibly and 1 probably related to GTB-3550) |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Possibly related to GTB-3550) Grade 2 Count: 2 (1 Possibly related to GTB-3550) |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unlikely related to GTB-3550) |
|
| Muscle spasms, intermittent | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unlikely related to GTB-3550) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 2 (Unrelated to GTB-3550) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 3 (Unrelated or unlikely related to GTB-3550) |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Possibly related to GTB-3550) |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 10 (2 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) |
|
| Lethargy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unlikely related to GTB-3550) |
|
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unrelated to GTB-3550) |
|
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Restlesness | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unrelated to GTB-3550) |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 2 (Unrelated or unlikely related to GTB-3550) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 5 (3 possibly related to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550) |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 3 (2 possibly related to GTB-3550) Grade 2 Count: 5 (3 possibly related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550) |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Unlikely related to GTB-3550) |
|
| On oxygen with no documented hypoxia, intermittent | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 2 Count: 1 (Possibly related to GTB-3550) |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unlikely related to GTB-3550) |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) Grade 2 Count: 1 (Unlikely related to GTB-3550) Grade 3 Count: 1 (Unlikely related to GTB-3550) |
|
| Rash - L leg | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Unrelated to GTB-3550) |
|
| Flushing | Vascular disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 1 (Possibly related to GTB-3550) |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 3 (1 possibly related to GTB-3550) Grade 2 Count: 4 (Unrelated or unlikely related to GTB-3550) Grade 3 Count: 4 (Unrelated to GTB-3550) |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment | Grade 1 Count: 9 (8 possibly and 1 probably related to GTB-3550) Grade 2 Count: 3 (3 possibly related to GTB-3550) |
|
This trial was terminated due to plans to clinically advance a modified second generation TriKE, requiring a new phase 1 study. Given this early termination, the maximal tolerated dose was not reached and the study did not proceed to phase 2. As only 12 participants were enrolled, the outcomes are presented in summary/descriptive format only.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Berk | GT Biopharma, Inc. | 925-719-3531 | gb@gtbiopharma.com |
| Sep 7, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D034721 | Mastocytosis, Systemic |
| D007946 | Leukemia, Mast-Cell |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008415 | Mastocytosis |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D000090362 | Mast Cell Activation Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Relapsed/Refractory AML - de novo AML |
|
| Relapsed/Refractory AML - Treatment-related |
|
| Myelodysplastic Syndrome (MDS) |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 9 |
|
| 50 ug/kg/day Dose |
|
| 100 ug/kg/day Dose |
|
| 150 ug/kg/day Dose |
|
| OG004 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. |
| OG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. |
|
|
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
| OG004 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. |
| OG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. |
|
|
| OG004 |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day |
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. |
| OG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. |
|
|
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
| OG004 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. |
| OG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. |
|
|
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
| OG004 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. |
| OG005 | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. |
|
|