Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.
This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1, Single Agent | Experimental | TTX-030 |
|
| Arm 2, Anti-PD-1 Combination | Experimental | TTX-030 plus pembrolizumab |
|
| Arm 4, Chemotherapy Combination | Experimental | TTX-030 plus gemcitabine plus nab-paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTX-030 | Drug | Variable dose and schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs. | 1 cycle (each cycle is 21-28 days) |
| Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts | Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint) | Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens | Through study completion, an average of 1 year |
| Maximum Plasma Concentration (Cmax) |
Not provided
Abreviated Inclusion Criteria
Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
Age 18 years or older, is willing and able to provide informed consent
Evidence of measurable disease
Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Abbreviated Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Cancer Center | Orange | California | 92868 | United States | ||
| UC Davis Comprehensive Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: TTX-030 0.5 mg/kg | Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| FG001 | Arm 1: TTX-030 1.5 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2020 | Nov 1, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pembrolizumab | Drug | Dose and schedule per standard of care |
|
| Gemcitabine | Drug | Dose and schedule per standard of care |
|
| nab paclitaxel | Drug | Dose and schedule per standard of care |
|
PK parameters of serum TTX-030 by Arm and Dose - Cycle 1 |
| Cycles 1-3 (each cycle is 21-28 days) |
| Sacramento |
| California |
| 95817 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Nebraska Cancer Center Oncology Hematology West P.C. | Omaha | Nebraska | 68130 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44122 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| West Cancer Center and Research Institute | Germantown | Tennessee | 38138 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Intitute | Salt Lake City | Utah | 84112 | United States |
Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle.
| FG002 | Arm 1: TTX-030 3.0 mg/kg | Participants in Arm 1 Escalation were administered IV 3.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| FG003 | Arm 1: TTX-030 6.0 mg/kg | Participants in Arm 1 Escalation were administered IV 6.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| FG004 | Arm 1: TTX-030 10 mg/kg | Participants in Arm 1 Escalation were administered IV 10 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| FG005 | Arm 1: TTX-030 20 mg/kg | Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| FG006 | Arm 1: TTX-030 40 mg/kg | Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| FG007 | Arm 1 Expansion: TTX-030 40 mg/kg Load, 30 mg/kg Q3W | Participants in Arm 1 Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W. |
| FG008 | Arm 2 (Safety Lead-in and Expansion), Combination | Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle. |
| FG009 | Arm 4 (Safety Lead-In and Expansion) | Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m^2 + nab-Paclitaxel 125 mg/m^2 Days 1, 8, and 15 every 28 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy, or relapsed/refractory lymphoma, for which all standard therapies had been previously given.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: TTX-030 0.5 mg/kg | Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| BG001 | Arm 1: TTX-030 1.5 mg/kg | Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| BG002 | Arm 1: TTX-030 3.0 mg/kg | Participants in Arm 1 Escalation were administered IV 3 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| BG003 | Arm 1: TTX-030 6.0 mg/kg | Participants in Arm 1 Escalation were administered IV 6 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| BG004 | Arm 1: TTX-030 10 mg/kg | Participants in Arm 1 Escalation were administered IV 10mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| BG005 | Arm 1: TTX-030 20 mg/kg | Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| BG006 | Arm 1: TTX-030 40 mg/kg | Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| BG007 | Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W | Participants in Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W. |
| BG008 | Arm 2 (Safety Lead-in and Expansion), Combination | Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle. |
| BG009 | Arm 4 (Safety Lead-In and Expansion) | Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m^2 + nab-Paclitaxel 125 mg/m^2 Days 1, 8, and 15 every 28 days. |
| BG010 | 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 |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs. | All participants in the Dose Escalation cohorts who received 1 infusion during the treatment cycle and completed safety evaluations through the end of the DLT period or experienced a DLT before the end of the DLT period (ie, participants started Cycle 2 or experienced a DLT). | Posted | Count of Participants | Participants | 1 cycle (each cycle is 21-28 days) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint) | Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens | Participants in the Safety Analysis Set who had at least 1 post baseline evaluable tumor assessment unless death or clinical progressive disease (PD) occurred before the first post baseline disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Through study completion, an average of 1 year |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) | PK parameters of serum TTX-030 by Arm and Dose - Cycle 1 | Dose-Normalized PK Parameters of Serum TTX-030 | Posted | Geometric Mean | Geometric Coefficient of Variation | Cmax (μg/mL) | Cycles 1-3 (each cycle is 21-28 days) |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts | Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens | Participants in the Safety Analysis Set who had at least 1 post baseline evaluable tumor assessment unless death or clinical progressive disease (PD) occurred before the first post baseline disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Through study completion, an average of 1 year |
|
|
Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: TTX-030 0.5 mg/kg | Participants in Arm 1 Escalation were administered IV 0.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Arm 1: TTX-030 1.5 mg/kg | Participants in Arm 1 Escalation were administered IV 1.5 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | 2 | 1 | 2 | 1 | 2 |
| EG002 | Arm 1: TTX-030 3.0 mg/kg | Participants in Arm 1 Escalation were administered IV 3.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG003 | Arm 1: TTX-030 6.0 mg/kg | Participants in Arm 1 Escalation were administered IV 6.0 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | 4 | 1 | 4 | 4 | 4 |
| EG004 | Arm 1: TTX-030 10 mg/kg | Participants in Arm 1 Escalation were administered IV 10 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG005 | Arm 1: TTX-030 20 mg/kg | Participants in Arm 1 Escalation were administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG006 | Arm 1: TTX-030 40 mg/kg | Participants in Arm 1 Escalation were administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day treatment cycle. | 3 | 6 | 4 | 6 | 3 | 6 |
| EG007 | Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W | Participants in Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W. | 1 | 8 | 2 | 8 | 6 | 8 |
| EG008 | Arm 2 (Safety Lead-in and Expansion), Combination | Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle. | 4 | 13 | 6 | 13 | 13 | 13 |
| EG009 | Arm 4 (Safety Lead-In and Expansion) | Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m^2 + nab-Paclitaxel 125 mg/m^2 Days 1, 8, and 15 every 28 days. | 7 | 14 | 4 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Generalized edema | General disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Back pain | Injury, poisoning and procedural complications | CTCAE v5.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE v5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Edema peripheral | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v5.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Muscular weakness | General disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE v5.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trishula Info | Trishula Therapeutics | (650) 509-5732 | info@trishulatx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2023 | Nov 1, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000093542 | Gemcitabine |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants in Arm 1: TTX-030 was administered IV 6.0 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| OG004 | Arm 1: TTX-030 10 mg/kg | Participants in Arm 1: TTX-030 was administered IV 10 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| OG005 | Arm 1: TTX-030 20 mg/kg | Participants in Arm 1: TTX-030 was administered IV 20 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| OG006 | Arm 1: TTX-030 40 mg/kg | Participants in Arm 1: TTX-030 was administered IV 40 mg/kg of TTX-030 Q3W on the first day of each 21-day treatment cycle. |
| OG007 | Arm 4 (Safety Lead-In and Expansion) | Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m^2 + nab-Paclitaxel 125 mg/m^2 Days 1, 8, and 15 every 28 days. |
|
|
| Arm 1: TTX-030 10 mg/kg |
Participants in Arm 1 was administered IV 10 mg/kg dose of TTX-030 Q3W on the first day of each 21-day. |
| OG005 | Arm 1: TTX-030 20 mg/kg | Participants in Arm 1 was administered IV 20 mg/kg dose of TTX-030 Q3W on the first day of each 21-day. |
| OG006 | Arm 1: TTX-030 40 mg/kg | Participants in Arm 1 was administered IV 40 mg/kg dose of TTX-030 Q3W on the first day of each 21-day. |
| OG007 | Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W | Participants in Arm 1 Expansion received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W. |
| OG008 | Arm 2 (Safety Lead-in and Expansion), Combination | Participants in Safety Lead-in portion and Expansion of Arm 2 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W and pembrolizumab IV at a dose of 200 mg on Day 1 of each 21-day treatment cycle. |
| OG009 | Arm 4 (Safety Lead-In and Expansion) | Participants in Safety Lead-in and Arm 4 received TTX-030 IV loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W and received gemcitabine 1000 mg/m^2 + nab-Paclitaxel 125 mg/m^2 Days 1, 8, and 15 every 28 days. |
|
|
|