Trial Outcomes & Findings for A Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors (NCT NCT04925947)

NCT ID: NCT04925947

Last Updated: 2024-04-16

Results Overview

Disease response rate

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: Up to 8 weeks
• Results posted on: 2024-04-16

Participant Flow

Participant milestones

Measure	KN046 KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors

Baseline characteristics by cohort

Measure	KN046 n=4 Participants KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Disease response rate

Outcome measures

Measure	KN046 n=4 Participants KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Anti-tumor Activity of KN046 in Subjects With Thymic Carcinoma, Determined by Subject Disease Response Rate Defined by the RECIST 1.1 Criteria.	0 count of participants

SECONDARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Measure	KN046 n=4 Participants KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Safety of KN046 in Subjects With Thymic Carcinoma, Measured by the Number of Adverse Events That Occur in Subjects While Receiving Study Treatment.	20 adverse events

SECONDARY outcome

Timeframe: Up to 8 weeks

AEs are graded using the following criteria using Common Terminology Criteria for Adverse events v5.0:

Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.

Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.

Grade 4: Life-threatening consequences; urgent intervention indicated.

Grade 5: Death related to AE.

Outcome measures

Measure	KN046 n=4 Participants KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Tolerability of KN046 in Subjects With Thymic Carcinoma, Measured by the Severity of Adverse Events That Occur in Subjects While Receiving Study Treatment, Assessed Using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade 1	13 adverse events
Tolerability of KN046 in Subjects With Thymic Carcinoma, Measured by the Severity of Adverse Events That Occur in Subjects While Receiving Study Treatment, Assessed Using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade 2	7 adverse events
Tolerability of KN046 in Subjects With Thymic Carcinoma, Measured by the Severity of Adverse Events That Occur in Subjects While Receiving Study Treatment, Assessed Using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade 3	6 adverse events
Tolerability of KN046 in Subjects With Thymic Carcinoma, Measured by the Severity of Adverse Events That Occur in Subjects While Receiving Study Treatment, Assessed Using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade 4	1 adverse events

SECONDARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Measure	KN046 n=4 Participants KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Duration of Response for KN046 in Subjects With Thymic Carcinoma, Determined by Subject Disease Response Rate Defined by the RECIST 1.1 Criteria.	0 months

SECONDARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Measure	KN046 n=4 Participants KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Progression Free Survival (PFS) for KN046 in Subjects With Thymic Carcinoma, Determined by Subject Disease Response Rate Defined by the RECIST 1.1 Criteria.	0 participants

SECONDARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Measure	KN046 n=4 Participants KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Overall Survival (OS) for KN046 in Subjects With Thymic Carcinoma, Determined by Subject Disease Response Rate Defined by the RECIST 1.1 Criteria.	4 participants

Adverse Events

KN046

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	KN046 n=4 participants at risk KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Investigations Absolute Lymphocyte Count Decreased	50.0% 2/4 • Number of events 3 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Musculoskeletal and connective tissue disorders Back Pain	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Blood and lymphatic system disorders Leukocytosis	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Gastrointestinal disorders Gastroesophageal reflux disease	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.

Other adverse events

Measure	KN046 n=4 participants at risk KN046 will be given intravenously every 2 weeks. KN046: KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
Gastrointestinal disorders Diarrhea	50.0% 2/4 • Number of events 2 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
General disorders Fatigue	50.0% 2/4 • Number of events 2 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Skin and subcutaneous tissue disorders Night sweats	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 2 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Gastrointestinal disorders Bloating	25.0% 1/4 • Number of events 2 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Cardiac disorders Pericardial Effusion	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 2 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Skin and subcutaneous tissue disorders Dry Skin	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Gastrointestinal disorders Dry Mouth	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.
Cardiac disorders Chest pain - Cardiac	25.0% 1/4 • Number of events 1 • Up to 11.5 weeks Expected adverse events to monitor include infusion-related adverse events, hypersensitivity reactions and immune-related adverse events.

Additional Information

Barbara Ma

Weill Cornell Medicine

Phone: 646-962-6444

Email: btm9003@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place