Trial Outcomes & Findings for A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer (NCT NCT05141357)
NCT ID: NCT05141357
Last Updated: 2025-12-24
Results Overview
Number of participants experiencing treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
From the start of treatment until 30 days after the last dose of HBI-8000, up to approximately 13 months
Results posted on
2025-12-24
Participant Flow
This was a multicenter (9 sites in the US: hospital, regional medical, and research centers), open label, Phase 2 study of HBI 8000 in combination with an approved dose of pembrolizumab as a first line checkpoint inhibitor therapy for advanced or metastatic non-small cell lung cancer (NSCLC). Recruitment was from 15Feb 2022 to 01Sep2022. In December 2022, enrollment was suspended.
Subjects had to satisfy screening criteria prior to treatment with HBI-8000 + Pembrolizumab. The screening period could be up to 28 days and was comprised of assessing medical history, concomitant therapies, clinical laboratory testing, and other clinical assessments to document the subject met all inclusion criteria and none of the exclusion criteria.
Participant milestones
| Measure |
HBI-8000 in Combination With Pembrolizumab
HBI-8000 in combination with pembrolizumab: Participants will take 30 mg of HBI-8000 by mouth every 3-4 days on a twice weekly (BIW) schedule. Pembrolizumab was administered at 400 mg IV every 6 weeks (Q6W) or 200 mg IV every 3 weeks (Q3W) according to Prescribing Information and institution's prescribing practice for pembrolizumab.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
HBI-8000 in Combination With Pembrolizumab
HBI-8000 in combination with pembrolizumab: Participants will take 30 mg of HBI-8000 by mouth every 3-4 days on a twice weekly (BIW) schedule. Pembrolizumab was administered at 400 mg IV every 6 weeks (Q6W) or 200 mg IV every 3 weeks (Q3W) according to Prescribing Information and institution's prescribing practice for pembrolizumab.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
HBI-8000 in Combination With Pembrolizumab
n=5 Participants
HBI-8000 in combination with pembrolizumab: Participants will take 30 mg of HBI-8000 by mouth every 3-4 days on a twice weekly (BIW) schedule. Pembrolizumab was administered at 400 mg IV every 6 weeks (Q6W) or 200 mg IV every 3 weeks (Q3W) according to Prescribing Information and institution's prescribing practice for pembrolizumab.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment until 30 days after the last dose of HBI-8000, up to approximately 13 monthsNumber of participants experiencing treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Outcome measures
| Measure |
HBI-8000 in Combination With Pembrolizumab
n=5 Participants
HBI-8000 in combination with pembrolizumab: Participants will take 30 mg of HBI-8000 by mouth every 3-4 days on a twice weekly (BIW) schedule. Pembrolizumab was administered at 400 mg IV every 6 weeks (Q6W) or 200 mg IV every 3 weeks (Q3W) according to Prescribing Information and institution's prescribing practice for pembrolizumab.
|
|---|---|
|
Safety and Tolerability of HBI-8000 When Administered in Combination With Standard Dose and Regimen of Pembrolizumab
Subjects experiencing TEAEs
|
5 Participants
|
|
Safety and Tolerability of HBI-8000 When Administered in Combination With Standard Dose and Regimen of Pembrolizumab
Subjects not experiencing TEAEs
|
0 Participants
|
Adverse Events
HBI-8000 in Combination With Pembrolizumab
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HBI-8000 in Combination With Pembrolizumab
n=5 participants at risk
HBI-8000 in combination with pembrolizumab: Participants will take 30 mg of HBI-8000 by mouth every 3-4 days on a twice weekly (BIW) schedule. Pembrolizumab was administered at 400 mg IV every 6 weeks (Q6W) or 200 mg IV every 3 weeks (Q3W) according to Prescribing Information and institution's prescribing practice for pembrolizumab.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Ileus
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
COVID-19 pneumonia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
Cellulitis
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Up to approximately 13 months
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Up to approximately 13 months
|
Other adverse events
| Measure |
HBI-8000 in Combination With Pembrolizumab
n=5 participants at risk
HBI-8000 in combination with pembrolizumab: Participants will take 30 mg of HBI-8000 by mouth every 3-4 days on a twice weekly (BIW) schedule. Pembrolizumab was administered at 400 mg IV every 6 weeks (Q6W) or 200 mg IV every 3 weeks (Q3W) according to Prescribing Information and institution's prescribing practice for pembrolizumab.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
3/5 • Up to approximately 13 months
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
60.0%
3/5 • Up to approximately 13 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.0%
3/5 • Up to approximately 13 months
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Up to approximately 13 months
|
|
Cardiac disorders
Cardiac failure
|
20.0%
1/5 • Up to approximately 13 months
|
|
Cardiac disorders
Pericardial effusion
|
20.0%
1/5 • Up to approximately 13 months
|
|
Cardiac disorders
Sinus tachycardia
|
40.0%
2/5 • Up to approximately 13 months
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
1/5 • Up to approximately 13 months
|
|
Ear and labyrinth disorders
Middle ear effusion
|
20.0%
1/5 • Up to approximately 13 months
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • Up to approximately 13 months
|
|
Eye disorders
Periorbital pain
|
20.0%
1/5 • Up to approximately 13 months
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Anal incontinence
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Diarrhoea
|
80.0%
4/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Feces discolored
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Lip pain
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Oral lichen planus
|
20.0%
1/5 • Up to approximately 13 months
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Up to approximately 13 months
|
|
General disorders
Asthenia
|
20.0%
1/5 • Up to approximately 13 months
|
|
General disorders
Fatigue
|
40.0%
2/5 • Up to approximately 13 months
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Up to approximately 13 months
|
|
General disorders
Oedema peripheral
|
40.0%
2/5 • Up to approximately 13 months
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
COVID-19 pneumonia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
Cellulitis
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
Fungal skin infection
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
Otitis media
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
Pneumonia
|
40.0%
2/5 • Up to approximately 13 months
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Up to approximately 13 months
|
|
Infections and infestations
Tooth infection
|
20.0%
1/5 • Up to approximately 13 months
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Up to approximately 13 months
|
|
Investigations
Amylase increased
|
40.0%
2/5 • Up to approximately 13 months
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
20.0%
1/5 • Up to approximately 13 months
|
|
Investigations
Lipase increased
|
40.0%
2/5 • Up to approximately 13 months
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Up to approximately 13 months
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Up to approximately 13 months
|
|
Investigations
Weight decreased
|
40.0%
2/5 • Up to approximately 13 months
|
|
Investigations
White blood cell count decreased
|
40.0%
2/5 • Up to approximately 13 months
|
|
Investigations
White blood cells urine positive
|
20.0%
1/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
80.0%
4/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
2/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
20.0%
1/5 • Up to approximately 13 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Up to approximately 13 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Up to approximately 13 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
40.0%
2/5 • Up to approximately 13 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Up to approximately 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
20.0%
1/5 • Up to approximately 13 months
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Up to approximately 13 months
|
|
Nervous system disorders
Nerve compression
|
20.0%
1/5 • Up to approximately 13 months
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Up to approximately 13 months
|
|
Renal and urinary disorders
Haematuria
|
20.0%
1/5 • Up to approximately 13 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
2/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
20.0%
1/5 • Up to approximately 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
1/5 • Up to approximately 13 months
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
20.0%
1/5 • Up to approximately 13 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
2/5 • Up to approximately 13 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
20.0%
1/5 • Up to approximately 13 months
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Up to approximately 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER