Acute Myelogenous Leukemia, High-risk Myelodysplastic Syndromes, Mast Cell Leukemia, Systemic Mastocytosis
Conditions
Keywords
Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML)
Brief summary
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.
Interventions
DRUGGTB-3550 TriKE® Phase I
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. * Dose Level 1 - 5 μg/kg/day * Dose Level 2 - 10 μg/kg/day * Dose Level 3 - 25 μg/kg/day * Dose Level 4 - 50 μg/kg/day * Dose Level 5 - 100 μg/kg/day * Dose Level 6 - 150 μg/kg/day * Dose Level 7 - 200 μg/kg/day
DRUGGTB-3550 TriKE® Phase II
Patients will receive the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.
Sponsors
GT Biopharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Revised International Prognostic Scoring System (IPSS-R) High or Very High Risks * World Health Organization (WHO) Classification: Refractory anemia with excess blasts-1 (RAEB-1) or RAEB-2 * Poor and very-poor risk cytogenetic abnormality as defined by the IPSS-R cytogenetic classifications * WHO Based Prognostic Scoring System (WPSS): High or Very High Risk * 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 * Not a candidate for hematopoietic stem cell transplant (HSCT), at least one re-induction attempt required * Prior HSCT relapse beyond 3 months may be included only if off immunosuppression for a minimum of 4 weeks and do not have graft-versus-host disease (GVHD) * 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: * Renal: an estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 * Hepatic: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and total bilirubin within normal range * Pulmonary function: Diffusing capacity for carbon monoxide (DLCO) corrected (ml/min/mm Hg) defined as no more than 5 units below lower limit of normal (Common Terminology Criteria for Adverse Events \[CTCAE\] v5 Grade 1 carbon monoxide diffusing capacity decreased) based on patient's height, weight, and gender as reported by the institutional pulmonary function lab. * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia; left ventricular ejection fraction ≥ 45% by echocardiogram, multigated acquisition (MUGA) scan or cardiac MRI. * 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
* New or progressive pulmonary infiltrates on screening chest x-ray or chest computerized tomography (CT) scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving with associated clinical improvement after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections). * Uncontrolled bacterial, fungal or viral infections, known history of HIV * Active Hepatitis B or Hepatitis C (virus detectable by polymerase chain reaction \[PCR\]) - chronic asymptomatic viral hepatitis is allowed * Other concurrent active cancer within the last year (excluding non-melanoma skin cancers) * Severely clinically obese patients, BMI \>38 * Currently taking any over-the-counter (OTC), vitamin, mineral, or dietary supplement within 14 days prior to study drug administration on Day 1 and during study conduct that may confound study safety goals (e.g., St. John's wort). Questions should be discussed with GT Biopharma. * Pregnant or breast feeding. The effect of GTB-3550 TriKE on the fetus is unknown. Females of childbearing potential must have a blood test within 7 days prior to enrollment to rule out pregnancy - must be repeated if not within 7 days of treatment initiation * History of central nervous system (CNS) malignancy or symptoms of active CNS disease * A family history of long QT syndrome or with a corrected QT (QTc) interval \> 480 msec at screening * Currently taking medications known to prolong QT/QTc interval as the potential risk of QT/QTc prolongation is unknown in humans. * A candidate for potentially curative therapy, including hematopoietic cell transplant * Unwilling to remain within a 90 minute drive of the study center through at least Day 29
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GTB-3550 Dosing Summary | Day 1 (start of GTB-3550 therapy) | 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. |
| GTB-3550 Extent of Treatment (Summary) | Day 28 relative to the start of GTB-3550 therapy | This outcome measure summarizes the number of GTB-3550 treatment blocks participants received during the first cycle of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Day 28 relative to the start of GTB-3550 therapy | The number of unexpected events in relation to GTB-3550 TriKE®. TEAEs were measured up to Day 28 relative to GTB-3550 therapy. |
| Overall Survival (OS) | 6 Months | Number of patients surviving at 6 months post-treatment on this study. |
| Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | After Day 28 Relative to 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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 |
| 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. | 2 |
| 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. | 2 |
| 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. | 2 |
| 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 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Cohort 5: Dose Level 5: 100 ug/kg/Day | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day | GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Baseline Disease Myelodysplastic Syndrome (MDS) | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Baseline Disease Relapsed/Refractory Acute Myeloid Leukemia (AML) - Secondary AML | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Baseline Disease Relapsed/Refractory AML - de novo AML | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Baseline Disease Relapsed/Refractory AML - Treatment-related | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Number of Prior Lines of Cancer Therapy 2 | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Number of Prior Lines of Cancer Therapy 3 | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Number of Prior Lines of Cancer Therapy 4 | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Number of Prior Lines of Cancer Therapy 5 | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Number of Prior Lines of Cancer Therapy 6 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Number of Prior Lines of Cancer Therapy 7 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Number of Prior Lines of Cancer Therapy 9 | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 12 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 2 participants | 2 participants | 2 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 2 / 2 | 0 / 2 | 1 / 2 | 1 / 2 | 2 / 2 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 1 / 2 | 0 / 2 | 1 / 2 | 1 / 2 |
Outcome results
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.
Time frame: Day 1 (start of GTB-3550 therapy)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Dosing Summary | 5 ug/kg/day Dose | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Dosing Summary | 10 ug/kg/day Dose | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Dosing Summary | 25 ug/kg/day Dose | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Dosing Summary | 50 ug/kg/day Dose | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Dosing Summary | 100 ug/kg/day Dose | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Dosing Summary | 150 ug/kg/day Dose | 2 Participants |
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.
Time frame: Day 28 relative to the start of GTB-3550 therapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Blocks 1-3 | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Only Blocks 1 and 2 | 0 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Blocks 1-3 | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Only Blocks 1 and 2 | 0 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Blocks 1-3 | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Only Blocks 1 and 2 | 0 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Blocks 1-3 | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Only Blocks 1 and 2 | 0 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Blocks 1-3 | 1 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Only Blocks 1 and 2 | 1 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Blocks 1-3 | 2 Participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | GTB-3550 Extent of Treatment (Summary) | Number of Participants Completing Only Blocks 1 and 2 | 0 Participants |
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.
Time frame: Day 28 relative to the start of GTB-3550 therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related TEAEs | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related Serious Adverse Events | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related TEAEs | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related Serious Adverse Events | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related TEAEs | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related Serious Adverse Events | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related TEAEs | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related Serious Adverse Events | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related TEAEs | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related Serious Adverse Events | 0 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related TEAEs | 3 Events |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Unexpected and Related Serious Adverse Events | 0 Events |
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.
Time frame: After Day 28 Relative to GTB-3550 Therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | 0 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | 0 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy | 1 participants |
Secondary
Overall Survival (OS)
Number of patients surviving at 6 months post-treatment on this study.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | Overall Survival (OS) | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Overall Survival (OS) | 0 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Overall Survival (OS) | 2 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Overall Survival (OS) | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Overall Survival (OS) | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Overall Survival (OS) | 0 participants |
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').
Time frame: 2-4 weeks after completion of the 1st cycle of therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GTB-3550 TriKE® (Phase I: Dose Finding Component) | Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day | Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy | 0 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day | Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy | 1 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day | Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy | 0 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day | Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy | 0 participants |
| GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day | Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy | 0 participants |