Phase 2 Study of TTX-030 and Chemotherapy With or Without... | NCT06119217

Name	Class
AbbVie	INDUSTRY

Label	Type	Description	Intervention Names
Arm 1	Experimental	TTX-030 plus nab-paclitaxel and gemcitabine	Combination Product: TTX-030, nab-paclitaxel and gemcitabine
Arm 2	Experimental	TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine	Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Arm 3	Active Comparator	Nab-Paclitaxel and gemcitabine	Combination Product: Nab-Paclitaxel and gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
TTX-030, nab-paclitaxel and gemcitabine	Combination Product	Dose and schedule per protocol	Arm 1

Measure	Description	Time Frame
Progression-free Survival (PFS) - Biomarker Enriched Population	PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first	Through study completion, an average of 1 year

Measure	Description	Time Frame
Progression-free Survival (PFS) - Overall Population	PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first.	Through study completion, an average of 1 year
Objective Response Rate (ORR) - Biomarker Enriched Population

Facility	Status	City	State	ZIP	Country	Contacts
Investigative Site		Tucson	Arizona	85704	United States
Investigative SIte

ID	Title	Description
FG000	Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
FG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 13, 2024	Feb 20, 2026

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

Progression-free Survival (PFS) - Biomarker Enriched Population

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first

Biomarker enriched participants

Posted

Median

95% Confidence Interval

months

Through study completion, an average of 1 year

ID	Title	Description
OG000	Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG002	Arm 3 - Nab-Paclitaxel and Gemcitabine	Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

Units	Counts
Participants	OG00045 OG00132 OG00248

Title

Denominators

Categories

Title	Measurements
	OG0005.5(3.7 to 7.3) OG0017.3(3.6 to 9.7) OG0025.9(3.6 to 9.0)

Secondary

Progression-free Survival (PFS) - Overall Population

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first.

Intention to treat population (overall)

Posted

Median

95% Confidence Interval

months

Through study completion, an average of 1 year

ID	Title	Description
OG000	Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG002	Arm 3 - Nab-Paclitaxel and Gemcitabine	Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

Secondary

Objective Response Rate (ORR) - Biomarker Enriched Population

Objective response rate (ORR) is defined as the proportion of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR) as assessed by the investigators per RECIST v1.1. The BOR is the best response (in the order of CR, PR, stable disease [SD], and progressive disease [PD]) documented from the date of randomization until the end of study, first disease progression, death, or start of new anti-cancer therapy, or last documented assessment before ≥2 consecutive missing tumor assessments, whichever is earlier.

Biomarker Enriched Population

Posted

Number

95% Confidence Interval

proportion

Through study completion, an average of 1 year

ID	Title	Description
OG000	Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

Secondary

Overall Survival (OS) - Biomarker Enriched Population

OS is defined as the time from randomization until death due to any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Outcome measure is the Kaplan-Meier estimate of OS rate at 12 months.

ITT Analysis - Biomarker enriched

Posted

Number

95% Confidence Interval

proportion

Through study completion

ID	Title	Description
OG000	Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG002	Arm 3 - Nab-Paclitaxel and Gemcitabine	Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

Secondary

Number of Participants With Treatment Emergent Adverse Events

Number of treatment emergent adverse events in all participants who received any dose of study treatment.

All participants who received any study treatment.

Posted

Number

Number of Participants with TEAEs

Through study completion, up to a max of 2 years

ID	Title	Description
OG000	Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG002	Arm 3 - Nab-Paclitaxel and Gemcitabine	Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG0003 affected66 at risk EG0013 affected60 at risk EG0021 affected68 at risk
Anemia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0012 affected60 at risk EG0020 affected68 at risk
Neutropenia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Pancytopenia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Thrombocytopenia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Atrial fibrillation	Cardiac disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Cardiac failure congestive	Cardiac disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Supraventricular tachycardia	Cardiac disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Haemophilia	Congenital, familial and genetic disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Retinal tear	Eye disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0013 affected60 at risk EG0023 affected68 at risk
Ascites	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Vomiting	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0003 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Colitis	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Abdominal pain upper	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Diarrhoea	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0012 affected60 at risk EG0020 affected68 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Nausea	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Obstruction gastric	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Abdominal distension	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Duodenal ulcer	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Enterocolitis	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Gastric ulcer	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Haematochezia	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Intestinal obstruction	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Large intestinal obstruction	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Pyrexia	General disorders	CTCAE v5.0	Systematic Assessment	EG0003 affected66 at risk EG0014 affected60 at risk EG0021 affected68 at risk
Asthenia	General disorders	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Generalised oedema	General disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0023 affected68 at risk
Oedema peripheral	General disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Pain	General disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Fatigue	General disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Hyperpyrexia	General disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Cholangitis	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0022 affected68 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Jaundice	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Jaundice cholestatic	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Cholangitis acute	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Hepatic cytolysis	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Hepatic failure	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Hepatobiliary disease	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Cytokine release syndrome	Immune system disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Sepsis	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0003 affected66 at risk EG0013 affected60 at risk EG0021 affected68 at risk
Pneumonia	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0013 affected60 at risk EG0022 affected68 at risk
Abdominal infection	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Covid-19	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Liver abscess	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0012 affected60 at risk EG0020 affected68 at risk
Abdominal sepsis	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Bacteraemia	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Bacterial sepsis	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Biliary sepsis	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Cellulitis	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Clostridium difficile colitis	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Device related infection	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Diarrhoea infectious	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Enterococcal sepsis	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Enterocolitis infectious	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Influenza	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Lower respiratory tract infection	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Pneumonia pneumococcal	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Pneumonia viral	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Septic shock	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Urinary tract infection	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Fall	Injury, poisoning and procedural complications	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Anticoagulation drug level above therapeutic	Investigations	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Weight decreased	Investigations	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Decreased appetite	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0012 affected60 at risk EG0020 affected68 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Failure to thrive	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0022 affected68 at risk
Hypercalcaemia	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Hypokalaemia	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Hyponatraemia	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Cerebrovascular accident	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Embolic cerebral infarction	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Embolic stroke	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Haemorrhage intracranial	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Peripheral motor neuropathy	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Syncope	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Device dislocation	Product Issues	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Device leakage	Product Issues	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Device malfunction	Product Issues	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Renal failure	Renal and urinary disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0014 affected60 at risk EG0021 affected68 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0021 affected68 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0021 affected68 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0011 affected60 at risk EG0020 affected68 at risk
Drug eruption	Skin and subcutaneous tissue disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk
Deep vein thrombosis	Vascular disorders	CTCAE v5.0	Systematic Assessment	EG0000 affected66 at risk EG0010 affected60 at risk EG0022 affected68 at risk
Hypotension	Vascular disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0010 affected60 at risk EG0020 affected68 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG00029 affected66 at risk EG00130 affected60 at risk EG00231 affected68 at risk
Nausea	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG00028 affected66 at risk EG00129 affected60 at risk EG00231 affected68 at risk
Diarrhea	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG00029 affected66 at risk EG00128 affected60 at risk EG00222 affected68 at risk
Fatigue	General disorders	CTCAE v5.0	Systematic Assessment	EG00026 affected66 at risk EG00126 affected60 at risk EG00223 affected68 at risk
Asthenia	General disorders	CTCAE v5.0	Systematic Assessment	EG00021 affected66 at risk EG00121 affected60 at risk EG00219 affected68 at risk
Decreased appetite	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG00020 affected66 at risk EG00121 affected60 at risk EG00216 affected68 at risk
Neutrophil count decreased	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG00021 affected66 at risk EG00121 affected60 at risk EG00214 affected68 at risk
Oedema peripheral	General disorders	CTCAE v5.0	Systematic Assessment	EG00022 affected66 at risk EG00117 affected60 at risk EG00216 affected68 at risk
Constipation	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG00017 affected66 at risk EG00117 affected60 at risk EG00219 affected68 at risk
Vomiting	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG00017 affected66 at risk EG00119 affected60 at risk EG00215 affected68 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG00016 affected66 at risk EG00117 affected60 at risk EG00216 affected68 at risk
Pyrexia	General disorders	CTCAE v5.0	Systematic Assessment	EG00014 affected66 at risk EG00122 affected60 at risk EG00212 affected68 at risk
Aspartate aminotransferase increased	Investigations	CTCAE v5.0	Systematic Assessment	EG00015 affected66 at risk EG00114 affected60 at risk EG00216 affected68 at risk
Neutropenia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG00015 affected66 at risk EG00115 affected60 at risk EG00215 affected68 at risk
Alanine aminotransferase increased	Investigations	CTCAE v5.0	Systematic Assessment	EG00014 affected66 at risk EG00113 affected60 at risk EG00217 affected68 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE v5.0	Systematic Assessment	EG0008 affected66 at risk EG00114 affected60 at risk EG00221 affected68 at risk
Platelet count decreased	Investigations	CTCAE v5.0	Systematic Assessment	EG00012 affected66 at risk EG00116 affected60 at risk EG00214 affected68 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG00011 affected66 at risk EG00117 affected60 at risk EG0027 affected68 at risk
Thrombocytopenia	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG00013 affected66 at risk EG00110 affected60 at risk EG00212 affected68 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG00114 affected60 at risk EG00212 affected68 at risk
White blood cell count decreased	Blood and lymphatic system disorders	CTCAE v5.0	Systematic Assessment	EG0007 affected66 at risk EG00111 affected60 at risk EG00210 affected68 at risk
Headache	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG00011 affected66 at risk EG0017 affected60 at risk EG0027 affected68 at risk
Dysgeusia	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG00012 affected66 at risk EG0015 affected60 at risk EG0027 affected68 at risk
Stomatitis	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG00010 affected66 at risk EG0016 affected60 at risk EG0028 affected68 at risk
Neuropathy peripheral	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0005 affected66 at risk EG0019 affected60 at risk EG0029 affected68 at risk
Weight decreased	Investigations	CTCAE v5.0	Systematic Assessment	EG0007 affected66 at risk EG0018 affected60 at risk EG0027 affected68 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0009 affected66 at risk EG0017 affected60 at risk EG0025 affected68 at risk
Hypokalaemia	Investigations	CTCAE v5.0	Systematic Assessment	EG00010 affected66 at risk EG0016 affected60 at risk EG0025 affected68 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE v5.0	Systematic Assessment	EG0006 affected66 at risk EG0018 affected60 at risk EG0026 affected68 at risk
Urinary tract infection	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0007 affected66 at risk EG0014 affected60 at risk EG0029 affected68 at risk
Abdominal pain upper	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0006 affected66 at risk EG0016 affected60 at risk EG0027 affected68 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE v5.0	Systematic Assessment	EG0007 affected66 at risk EG0013 affected60 at risk EG0029 affected68 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0007 affected66 at risk EG0016 affected60 at risk EG0025 affected68 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0009 affected66 at risk EG0016 affected60 at risk EG0023 affected68 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE v5.0	Systematic Assessment	EG0006 affected66 at risk EG0016 affected60 at risk EG0025 affected68 at risk
Hypertension	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0015 affected60 at risk EG0028 affected68 at risk
Rash	Skin and subcutaneous tissue disorders	CTCAE v5.0	Systematic Assessment	EG0007 affected66 at risk EG0015 affected60 at risk EG0025 affected68 at risk
Chills	General disorders	CTCAE v5.0	Systematic Assessment	EG0005 affected66 at risk EG0014 affected60 at risk EG0027 affected68 at risk
Dizziness	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0006 affected66 at risk EG0017 affected60 at risk EG0023 affected68 at risk
Insomnia	Psychiatric disorders	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0015 affected60 at risk EG0029 affected68 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	CTCAE v5.0	Systematic Assessment	EG0006 affected66 at risk EG0016 affected60 at risk EG0024 affected68 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE v5.0	Systematic Assessment	EG0006 affected66 at risk EG0017 affected60 at risk EG0023 affected68 at risk
Hyperglycaemia	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0013 affected60 at risk EG0028 affected68 at risk
Hypotension	Vascular disorders	CTCAE v5.0	Systematic Assessment	EG0006 affected66 at risk EG0015 affected60 at risk EG0024 affected68 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0017 affected60 at risk EG0024 affected68 at risk
Ascites	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0008 affected66 at risk EG0015 affected60 at risk EG0021 affected68 at risk
Blood alkaline phosphatase increased	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0003 affected66 at risk EG0015 affected60 at risk EG0026 affected68 at risk
Anxiety	Psychiatric disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0014 affected60 at risk EG0024 affected68 at risk
COVID-19	Infections and infestations	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0014 affected60 at risk EG0026 affected68 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE v5.0	Systematic Assessment	EG0003 affected66 at risk EG0014 affected60 at risk EG0025 affected68 at risk
Dry mouth	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0017 affected60 at risk EG0021 affected68 at risk
Gamma-glutamyltransferase increased	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0005 affected66 at risk EG0011 affected60 at risk EG0025 affected68 at risk
Haematuria	Renal and urinary disorders	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0016 affected60 at risk EG0023 affected68 at risk
Hypertransaminasaemia	Hepatobiliary disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0013 affected60 at risk EG0027 affected68 at risk
Hypoalbuminaemia	Investigations	CTCAE v5.0	Systematic Assessment	EG0005 affected66 at risk EG0012 affected60 at risk EG0024 affected68 at risk
Paraesthesia	Nervous system disorders	CTCAE v5.0	Systematic Assessment	EG0005 affected66 at risk EG0014 affected60 at risk EG0022 affected68 at risk
Abdominal distension	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0013 affected60 at risk EG0023 affected68 at risk
Blood bilirubin increased	Gastrointestinal disorders	CTCAE v5.0	Systematic Assessment	EG0004 affected66 at risk EG0012 affected60 at risk EG0024 affected68 at risk
Deep vein thrombosis	Vascular disorders	CTCAE v5.0	Systematic Assessment	EG0002 affected66 at risk EG0011 affected60 at risk EG0027 affected68 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE v5.0	Systematic Assessment	EG0001 affected66 at risk EG0013 affected60 at risk EG0026 affected68 at risk

ID	Term
D010190	Pancreatic Neoplasms
D009369	Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description
BG000	Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
BG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
BG002	Arm 3 - Nab-Paclitaxel and Gemcitabine	Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
BG003	Total	Total of all reporting groups

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 Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.	36	66	38	66	64	66
EG001	Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine	Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.	33	60	40	60	59	60
EG002	Arm 3 - Nab-Paclitaxel and Gemcitabine	Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.	34	68	29	68	63	68

ID	Term
C520255	130-nm albumin-bound paclitaxel
D000093542	Gemcitabine
C000719868	budigalimab