Trial Outcomes & Findings for FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer (NCT NCT04768686)

Last Updated: 2025-09-25

Results Overview

The primary efficacy endpoint is Objective Response Rate (ORR) defined as the proportion of subjects whose confirmed best overall response is either Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1. For the efficacy endpoints (such as ORR and DCR), frequency and percentage of subjects who have achieved a response will be summarized by cohort and 95% 2-sided confidence interval will be calculated by Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.

Results posted on

2025-09-25

Participant Flow

Screening will occur from Day -30 to Day -1. Once screening procedures are completed and eligibility is confirmed, subjects will be enrolled for the study and start study treatment. There is no pre-assignment planned.

Participant milestones

Participant milestones
Measure	FLX475 and Pembrolizumab Combination Therapy * Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer * Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer FLX475: tablet Pembrolizumab: IV infusion
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for age were reported separately for each cohort (10 patients each).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FLX475 and Pembrolizumab Combination Therapy n=20 Participants * Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer * Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer FLX475: tablet Pembrolizumab: IV infusion
Age, Customized Total	64.5 years n=20 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for age were reported separately for each cohort (10 patients each).
Age, Customized Cohort 1	60.0 years n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for age were reported separately for each cohort (10 patients each).
Age, Customized Cohort 2	65.5 years n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for age were reported separately for each cohort (10 patients each).
Sex: Female, Male Total · Female	5 Participants n=20 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for sex were reported separately for each cohort (10 patients each).
Sex: Female, Male Total · Male	15 Participants n=20 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for sex were reported separately for each cohort (10 patients each).
Sex: Female, Male Cohort 1 · Female	3 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for sex were reported separately for each cohort (10 patients each).
Sex: Female, Male Cohort 1 · Male	7 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for sex were reported separately for each cohort (10 patients each).
Sex: Female, Male Cohort 2 · Female	2 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for sex were reported separately for each cohort (10 patients each).
Sex: Female, Male Cohort 2 · Male	8 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for sex were reported separately for each cohort (10 patients each).
Race/Ethnicity, Customized Total · Asian	20 Participants n=20 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for race/ethnicity were reported separately for each cohort (10 patients each).
Race/Ethnicity, Customized Total · Other	0 Participants n=20 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for race/ethnicity were reported separately for each cohort (10 patients each).
Race/Ethnicity, Customized Cohort 1 · Asian	10 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for race/ethnicity were reported separately for each cohort (10 patients each).
Race/Ethnicity, Customized Cohort 1 · Other	0 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for race/ethnicity were reported separately for each cohort (10 patients each).
Race/Ethnicity, Customized Cohort 2 · Asian	10 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for race/ethnicity were reported separately for each cohort (10 patients each).
Race/Ethnicity, Customized Cohort 2 · Other	0 Participants n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for race/ethnicity were reported separately for each cohort (10 patients each).
Baseline Height (cm) Total	165.31 cm STANDARD_DEVIATION 8.16 • n=20 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for baseline height were reported separately for each cohort (10 patients each).
Baseline Height (cm) Cohort 1	163.93 cm STANDARD_DEVIATION 8.94 • n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for baseline height were reported separately for each cohort (10 patients each).
Baseline Height (cm) Cohort 2	166.68 cm STANDARD_DEVIATION 7.51 • n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for baseline height were reported separately for each cohort (10 patients each).
BMI (kg/m2) Total	21.67 kg/m2 STANDARD_DEVIATION 3.77 • n=20 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for BMI were reported separately for each cohort (10 patients each).
BMI (kg/m2) Cohort 1	21.94 kg/m2 STANDARD_DEVIATION 2.75 • n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for BMI were reported separately for each cohort (10 patients each).
BMI (kg/m2) Cohort 2	21.39 kg/m2 STANDARD_DEVIATION 4.72 • n=10 Participants • This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for BMI were reported separately for each cohort (10 patients each).

PRIMARY outcome

Timeframe: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.

Population: The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population.

Outcome measures

Outcome measures
Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab	0 percentage of participants Interval 0.0 to 30.8	60.0 percentage of participants Interval 26.2 to 87.8

SECONDARY outcome

The Disease Control Rate (DCR) is defined as the proportion of subjects with confirmed best overall response of CR, PR or SD according to RECIST version 1.1.

Outcome measures

Outcome measures
Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Disease Control Rate (DCR) in Subjects Treated With FLX475 in Combination With Pembrolizumab	20.0 percentage of participants Interval 2.5 to 55.6	60.0 percentage of participants Interval 26.2 to 87.8

SECONDARY outcome

The Time to Response (TTR) is defined as the time from the date of first administration of study treatment to first documented Complete Response (CR) or Partial Response (PR).

Outcome measures

Outcome measures
Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Time to Response (TTR) in Subjects Treated With FLX475 in Combination With Pembrolizumab	NA months Not available due to no responder.	2.7 months Interval 1.2 to Not estimable due to insufficient events near the median.

SECONDARY outcome

The Duration of Response (DoR) is measured from the date of the first observation of tumor response (Complete Response (CR) or Partial Response (PR), whichever occurs first) to the date of disease progression or death for the subject with an objected response.

Outcome measures

Outcome measures
Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n=6 Participants ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Duration of Response (DoR) in Subjects Treated With FLX475 in Combination With Pembrolizumab	—	17.3 months Interval 2.7 to Not estimable due to insufficient events near the median.

SECONDARY outcome

The Progression-free Survival (PFS) is defined as the time from the date of first administration of study treatment to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Progression-free Survival (PFS) in Subjects Treated With FLX475 in Combination With Pembrolizumab	1.4 months Interval 1.1 to 1.5	10.4 months Interval 1.0 to Not estimable due to insufficient events near the median.

SECONDARY outcome

Timeframe: From baseline (Cycle 1 Day 1 prior to administration of the first study dose) until death from any cause.

The Overall Survival (OS) is defined as the duration of time from the treatment start date to time to death from any cause. If subjects survive at the time of analysis, the subject will be censored at the last date of survival confirmed.

Outcome measures

Outcome measures
Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n=10 Participants ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Overall Survival (OS) in Subjects Treated With FLX475 in Combination With Pembrolizumab	7.5 months Interval 1.4 to Not estimable due to insufficient events near the median.	NA months Interval 2.3 to Not estimable due to insufficient events.

Adverse Events

Cohort 1: EBV Negative / CPI naïve Gastric Cancer

Serious events: 2 serious events

Other events: 9 other events

Deaths: 3 deaths

Cohort 2: EBV Positive / CPI naïve Gastric Cancer

Serious events: 5 serious events

Other events: 10 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer n=10 participants at risk ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n=10 participants at risk ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Gastrointestinal disorders Gastrointestinal haemorrhage	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Gastrointestinal disorders Internal hernia	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Gastrointestinal disorders Obstruction gastric	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Metabolism and nutrition disorders Acidosis	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
General disorders Asthenia	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Investigations Blood creatinine increased	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
Renal and urinary disorders Calculus bladder	10.0% 1/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.	0.00% 0/10 • Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months. Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.

Other adverse events

Additional Information

Young Su (Bobby) Noh

Hanmi Pharm. Co., Ltd.

Phone: 82-2-410-9277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER