NCT05714553 · ADVERSE EVENTS

Adverse events

NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours · Source last updated 2026-07-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Other-event reporting threshold: 0%

Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Module 1 (NUC-3373 + LV + Pembrolizumab) This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.	7 / 13	13 / 13	10 / 13
Module 2 (NUC-3373 + LV + Docetaxel) This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.	3 / 4	4 / 4	3 / 4

Group identifiers: EG000: Module 1 (NUC-3373 + LV + Pembrolizumab) · EG001: Module 2 (NUC-3373 + LV + Docetaxel)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Dizziness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Kidney infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Spinal cord compression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
3
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Hypercalcemia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
13
num Events
20
group Id
EG001
num Affected
1
num At Risk
4
num Events
4
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
13
num Events
16
group Id
EG001
num Affected
2
num At Risk
4
num Events
8
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
13
num Events
14
group Id
EG001
num Affected
2
num At Risk
4
num Events
7
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
9
group Id
EG001
num Affected
2
num At Risk
4
num Events
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
5
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Angular cheilitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Dental caries
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Food poisoning
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Salivary hypersecretion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
term
Stomatitis

Complete source fields

description

event Groups

deaths Num Affected
10
deaths Num At Risk
13
description
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
7
serious Num At Risk
13
title
Module 1 (NUC-3373 + LV + Pembrolizumab)
deaths Num Affected
3
deaths Num At Risk
4
description
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Module 2 (NUC-3373 + LV + Docetaxel)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
13
num Events
20
group Id
EG001
num Affected
1
num At Risk
4
num Events
4
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
13
num Events
16
group Id
EG001
num Affected
2
num At Risk
4
num Events
8
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
13
num Events
14
group Id
EG001
num Affected
2
num At Risk
4
num Events
7
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
9
group Id
EG001
num Affected
2
num At Risk
4
num Events
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
5
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Angular cheilitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Dental caries
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Food poisoning
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Salivary hypersecretion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
term
Stomatitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Dizziness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Kidney infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Spinal cord compression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
3
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Hypercalcemia

time Frame

Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice