Trial Outcomes & Findings for Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma (NCT NCT03921021)

Last Updated: 2024-06-25

Results Overview

The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

1 year

Results posted on

2024-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Telomelysin (OBP-301) All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Overall Study STARTED	17
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telomelysin (OBP-301) n=17 Participants All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 16 out of 17 enrolled participants were evaluable.

Outcome measures

Outcome measures
Measure	Telomelysin (OBP-301) n=16 Participants All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Overall Response Rate, as Assessed by Radiographic Imaging	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 16 out of 17 patients enrolled were evaluable.

Examination of subjects with stable disease, a partial response, or complete response reported as the number of participants who maintained stable disease, partial response, or complete response as per iRECIST through 1 year (SD + PR + CR). The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.

Outcome measures

Outcome measures
Measure	Telomelysin (OBP-301) n=16 Participants All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Disease Control Rate, as Assessed by Radiographic Imaging	4 Participants

SECONDARY outcome

Timeframe: 2.5 years

Population: 3 out of 17 enrolled patients were evaluable for duration of response.

Defined as the duration that subjects who have responded to combination therapy remain without disease progression. The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.

Outcome measures

Outcome measures
Measure	Telomelysin (OBP-301) n=3 Participants All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Duration of Response, as Assessed by Radiographic Imaging	498 days Interval 461.0 to 758.0

SECONDARY outcome

Timeframe: 1 year

Population: 14 out of 17 enrolled participants were evaluable for survival at 1 year from registration.

Defined as the number of participants who survived until 1 year from enrollment

Outcome measures

Outcome measures
Measure	Telomelysin (OBP-301) n=14 Participants All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Overall Survival Rate, as Assessed by Survival	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 16 out of 17 participants enrolled were evaluable.

The number of participants who did not progress as determined by iRECIST, or die by 1 year. The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.

Outcome measures

Outcome measures
Measure	Telomelysin (OBP-301) n=16 Participants All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Progression Free Survival Rate, as Assessed by Radiographic Imaging and Survival.	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 2 years

In this aim we will summarize the results from all patient data to assess what are the consistent changes observed in cellular composition in response to immunotherapy and we will investigate how these changes impact response to treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 2 years

This project will be focused on analyzing the immune landscape of individual tumors from tumor biopsies taken at baseline and on therapy. We will analyze changes associated with relapse and differences between refractory and sensitive patients. Our proposed analysis will take as input somatic mutations, raw WES reads, and raw RNA-Seq reads

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 2 years

This powerful approach will be utilized to characterize tumor immune cell infiltrates at baseline, following the induction of combination therapy and at the time of resection. This will be one of the first longitudinal analyses of tumor immune cell infiltrates by multi-parameter flow cytometry following immunotherapy.

Outcome measures

Outcome data not reported

Adverse Events

Telomelysin (OBP-301)

Serious events: 15 serious events

Other events: 17 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Telomelysin (OBP-301) n=17 participants at risk All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Gastrointestinal disorders Other: Gastrointestinal Bleed	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Other: Muscle weakness	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Metabolism and nutrition disorders Other: Type 1 Diabetes Mellitus	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Infections and infestations Sepsis	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Blood and lymphatic system disorders Anemia	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Cardiac disorders Pericardial Tamponade	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Psychiatric disorders Confusion	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	17.6% 3/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Metabolism and nutrition disorders Hyponatremia	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Metabolism and nutrition disorders Anorexia	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Fever	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.

Other adverse events

Other adverse events
Measure	Telomelysin (OBP-301) n=17 participants at risk All patients will receive Telomelysin (OBP-301) at 2x10\^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Telomelysin: OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
Blood and lymphatic system disorders Anemia	17.6% 3/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Cardiac disorders Acute coronary syndrome	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Cardiac disorders Sinus tachycardia	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Ear and labyrinth disorders Other - Ear and labyrinth disorders (Decreased hearing)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Eye disorders Dry Eye	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Eye disorders Others - Eye disorders (Intermittent Vision fogginess and Left-sided eye lid lag)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Abdominal distension	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Abdominal pain	23.5% 4/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Bloating	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Constipation	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Diarrhea	17.6% 3/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Dysphagia	17.6% 3/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Esophagitis	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Flatulence	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Gastroesophageal reflux disease	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Nausea	29.4% 5/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Vomiting	35.3% 6/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Gastrointestinal bleed)	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Dark stool)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Epigastric pain and Abdominal Mass)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Small bowel obstruction)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Dry heaving)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Abdominal tenderness)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Belching)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Melena)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other - Gastrointestinal disorder (Balance Issues)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Chills	23.5% 4/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Edema limbs	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Fatigue	41.2% 7/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Fever	29.4% 5/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Flu like symptoms	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Other (Delayed Speech and Ill-appearing )	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Other (Cold Sore, Edema and Localized pain near injection site)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
General disorders Other (lightheadedness)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Immune system disorders Other (Cervical Adenopathy)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Infections and infestations Sepsis	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Infections and infestations Sinusitis	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Alanine aminotransferase increased	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Alkaline phosphatase increased	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Aspartate aminotransferase increased	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Blood bilirubin increased	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Creatinine increased	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Weight loss	17.6% 3/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Other (Blood urea nitrogen increased)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Investigations Other (Hyponatremia)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Metabolism and nutrition disorders Anorexia	47.1% 8/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Metabolism and nutrition disorders Dehydration	17.6% 3/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Metabolism and nutrition disorders Other (Hyponatremia)	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Back pain	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	47.1% 8/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Other (Pain to left ribs)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Other (Body Aches)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Musculoskeletal and connective tissue disorders Other (Left flank pain)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Nervous system disorders Dizziness	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Nervous system disorders Tremor	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Nervous system disorders Other (Cranial face deficit and Facial asymmetry)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Psychiatric disorders Anxiety	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Psychiatric disorders Confusion	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Psychiatric disorders Hallucinations	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Psychiatric disorders Other (Nervousness)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Psychiatric disorders Other (Slow behavior and Distress)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Renal and urinary disorders Hematuria	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Gastrointestinal disorders Other (Rectal bleeding)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Respiratory, thoracic and mediastinal disorders Wheezing	11.8% 2/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Respiratory, thoracic and mediastinal disorders Other- Shortness of Breath	17.6% 3/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Skin and subcutaneous tissue disorders Rash acneiform	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Skin and subcutaneous tissue disorders Other (Pallor)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Skin and subcutaneous tissue disorders Other (Small pustule on scrotum)	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Vascular disorders Hypertension	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.
Vascular disorders Hypotension	5.9% 1/17 • Adverse events were collected until 30 days following last dose of study drug for a maximum of approximately 2 years.

Additional Information

Manish Shah, MD

Weill Cornell Medicine

Phone: (646) 962-6200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place