Trial Outcomes & Findings for Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) (NCT NCT02953652)

NCT ID: NCT02953652

Last Updated: 2024-09-19

Results Overview

Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR) according to International Workshop Response Criteria (IWC) 2014 criteria and assessed by an Independent Overall Efficacy Review Committee (IOERC). CR: Target nodes/nodal masses must regress to \<1.5 cm in longest transverse diameter of a lesion (LDi), no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no bone marrow (BM) involvement. PR: ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: Up to approximately 47 months.
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	HBI-8000 Four 10 mg tablets or less twice weekly orally approximately 30 minutes after any regular meal. The treatment will be continuous, with 3-4 days between dosing. Treatment will continue until disease progression in the absence of unacceptable toxicity. HBI-8000: Orally twice weekly
Overall Study STARTED	55
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Measure	HBI-8000 Four 10 mg tablets or less twice weekly orally approximately 30 minutes after any regular meal. The treatment will be continuous, with 3-4 days between dosing. Treatment will continue until disease progression in the absence of unacceptable toxicity. HBI-8000: Orally twice weekly
Overall Study Adverse Event	18
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	1
Overall Study Disease Progression	27

Baseline Characteristics

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Baseline characteristics by cohort

Measure	HBI-8000 n=55 Participants Four 10 mg tablets or less twice weekly orally approximately 30 minutes after any regular meal. The treatment will be continuous, with 3-4 days between dosing. Treatment will continue until disease progression in the absence of unacceptable toxicity. HBI-8000: Orally twice weekly
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	55 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	0 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 South Korea	16 participants n=5 Participants
Region of Enrollment Japan	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 47 months.

Population: The per-protocol analysis set (PPS) included subjects meeting all eligibility criteria who have completed Cycle 1 treatment. For subjects who developed clinical PD and discontinued study treatment during Cycle 1 without significant deviation from protocol, they will be included in the PPS. It should be noted that the PPS includes subjects who discontinued within Cycle 1 due to clinical PD without imaging studies to assess disease status.

Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR) according to International Workshop Response Criteria (IWC) 2014 criteria and assessed by an Independent Overall Efficacy Review Committee (IOERC).

CR: Target nodes/nodal masses must regress to <1.5 cm in longest transverse diameter of a lesion (LDi), no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no bone marrow (BM) involvement.

PR: ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by >50% in length beyond normal, no new lesions.

Outcome measures

Measure	HBI-8000 n=46 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Objective Response Rate	21 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 47 months.

Population: PPS \[Per Protocol Set\]

Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a CR or a PR according to IWC 2014 criteria and assessed by an IOERC.

CR: Target nodes/nodal masses must regress to <1.5 cm in LDi, no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no BM involvement.

PR: ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by >50% in length beyond normal, no new lesions.

Disease subtype (PTCL-NOS, AITL, ALCL, ALK, EATL) was assessed by Central Pathology Review (CPR).

Outcome measures

Measure	HBI-8000 n=34 Participants HBI-8000 tablets	AITL n=8 Participants Angioimmunoblastic T-cell lymphoma	ALCL, ALK- n=3 Participants Anaplastic Large-cell Lymphoma, ALK-	EATL n=1 Participants Enteropathy-associated T-cell lymphoma
Objective Response Rate by Disease Subtype	12 Participants	7 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 47 months.

Population: PPS

PFS was defined as the duration from the date of the first study drug dose to the disease progression or death, whichever occurs first. PD was defined using the IWC 2014 criteria, as any new lesion or an individual node/lesion must be abnormal with: "LDi >1.5 cm" and "increase by 50% from perpendicular diameters nadir" and "an increase in LDi or shortest axis perpendicular to the LDi from nadir, 0.5 cm for lesions <2 cm or 1.0 cm for lesions >2 cm".

Outcome measures

Measure	HBI-8000 n=46 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Median Duration of Progression-free Survival (PFS)	5.5 Months Interval 2.9 to 24.0	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 47 months.

Population: Subjects who achieved PR or CR in the PPS

DOR was defined as the duration of response from first response (CR/PR) to disease progression or death, whichever occurs first. CR or PR according to the IWC 2014 criteria was assessed by an IOERC.

Outcome measures

Measure	HBI-8000 n=21 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Median Duration of Response (DOR)	25.7 Months Interval 5.4 to Not estimable due to the low number of events	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 44 months.

Population: Safety analysis set (SAF) includes all subjects who received at least one dose of HBI 8000.

Safety evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

From date of first study drug to 30±3 days after the last dosing of the study drug or before the initiation of new cancer treatment.

Outcome measures

Measure	HBI-8000 n=55 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0	51 Participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 55 months.

Population: PPS - Per Protocol Set

Overall survival is defined as the duration from the first dose of study medication to death from any cause.

Outcome measures

Measure	HBI-8000 n=46 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Median Duration of Overall Survival (OS)	33.6 Months Interval 16.5 to Not estimable due to the low number of events	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 (predose) up to 72 hours postdose on C1D1 and 0 (predose) up to 4 hours postdose on C2D1

Population: PK population includes all subjects, at the selected sites in Japan and all sites in South Korea, who have pretreatment baseline and at least 1 blood sample on study providing PK data for HBI-8000.

Maximum observed plasma concentration (ng/mL), obtained directly from the observed concentration versus time data. Calculated for the C1D1 and C2D1 doses.

Outcome measures

Measure	HBI-8000 n=26 Participants HBI-8000 tablets	AITL n=8 Participants Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Pharmacokinetics (Cmax-selected Sites)	220 ng/mL Interval 71.9 to 650.0	254 ng/mL Interval 118.0 to 483.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 (predose) up to 72 hours postdose on C1D1

Population: PK population includes all subjects, at the selected sites in Japan and all sites in South Korea, who have pretreatment baseline and at least 1 blood sample on study providing PK data for HBI-8000.

Area under the plasma concentration time curve from zero (predose) extrapolated to infinity (ng*h/mL) (Day 1 only), calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration (Clast) divided by the apparent terminal rate constant (λz): AUC(0-last) + Clast/λz. Calculated for the C1D1 dose only.

Outcome measures

Measure	HBI-8000 n=26 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Pharmacokinetics AUC (0-INF)	5330 ng*h/mL Interval 2230.0 to 9110.0	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 (predose) up to 72 hours postdose on C1D1

Population: PK population includes all subjects, at the selected sites in Japan and all sites in South Korea, who have pretreatment baseline and at least 1 blood sample on study providing PK data for HBI-8000.

Area under the plasma concentration time curve over the dosing interval tau (ng*h/mL), calculated by linear up/log down trapezoidal summation. Calculated for the C1D1 dose only. Actual elapsed sampling time at tau and the corresponding plasma concentration was used in the calculation of this parameter. If concentrations fall to BLQ before or at tau, AUCall (area under the plasma concentration time curve from zero [predose] to the time of the last observation within the dosing interval, calculated by linear up/log down trapezoidal summation) was used as the estimate of this parameter.

Outcome measures

Measure	HBI-8000 n=26 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
Pharmacokinetics AUC (0-tau)	4740 ng*h/mL Interval 2130.0 to 8630.0	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 (predose) up to 72 hours postdose on C1D1

Population: PK population includes all subjects, at the selected sites in Japan and all sites in South Korea, who have pretreatment baseline and at least 1 blood sample on study providing PK data for HBI-8000.

Apparent terminal half-life (h), calculated as (ln 2)/λz. Calculated for the C1D1 dose only.

Outcome measures

Measure	HBI-8000 n=26 Participants HBI-8000 tablets	AITL Angioimmunoblastic T-cell lymphoma	ALCL, ALK- Anaplastic Large-cell Lymphoma, ALK-	EATL Enteropathy-associated T-cell lymphoma
t 1/2	17.7 hour Interval 14.3 to 25.5	—	—	—

Adverse Events

HBI-8000

Serious events: 15 serious events

Other events: 55 other events

Deaths: 1 deaths

Serious adverse events

Measure	HBI-8000 n=55 participants at risk HBI-8000 Tablets
Blood and lymphatic system disorders Febrile neutropenia	3.6% 2/55 • Number of events 2 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Blood and lymphatic system disorders Aplastic anaemia	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Cardiac disorders Angina unstable	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
General disorders Fatigue	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
General disorders Pyrexia	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Infections and infestations Pneumocystis jirovecii pneumonia	3.6% 2/55 • Number of events 2 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Infections and infestations Pharyngitis	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Infections and infestations Pneumonia	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations C-reactive protein increased	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Metabolism and nutrition disorders Hyponatraemia	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-cell lymphoma unspecified	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Renal and urinary disorders Acute kidney injury	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Vascular disorders Peripheral arterial occlusive disease	1.8% 1/55 • Number of events 1 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.

Other adverse events

Measure	HBI-8000 n=55 participants at risk HBI-8000 Tablets
Blood and lymphatic system disorders Anaemia	34.5% 19/55 • Number of events 19 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Blood and lymphatic system disorders Thrombocytopenia	29.1% 16/55 • Number of events 16 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Blood and lymphatic system disorders Neutropenia	20.0% 11/55 • Number of events 11 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Blood and lymphatic system disorders Leukopenia	10.9% 6/55 • Number of events 6 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Blood and lymphatic system disorders Lymphopenia	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Blood and lymphatic system disorders Febrile neutropenia	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Cardiac disorders Palpitations	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Gastrointestinal disorders Diarrhoea	34.5% 19/55 • Number of events 19 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Gastrointestinal disorders Nausea	21.8% 12/55 • Number of events 12 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Gastrointestinal disorders Abdominal pain	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Gastrointestinal disorders Toothache	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Gastrointestinal disorders Vomiting	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
General disorders Pyrexia	23.6% 13/55 • Number of events 13 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
General disorders Malaise	16.4% 9/55 • Number of events 9 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
General disorders Fatigue	10.9% 6/55 • Number of events 6 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
General disorders Oedema peripheral	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Infections and infestations Nasopharyngitis	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Infections and infestations Pharyngitis	7.3% 4/55 • Number of events 4 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Infections and infestations Upper respiratory tract infection	7.3% 4/55 • Number of events 4 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Infections and infestations Bronchitis	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Platelet count decreased	56.4% 31/55 • Number of events 31 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Neutrophil count decreased	38.2% 21/55 • Number of events 21 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations White blood cell count decreased	34.5% 19/55 • Number of events 19 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Lymphocyte count decreased	21.8% 12/55 • Number of events 12 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Blood alkaline phosphatase increased	14.5% 8/55 • Number of events 8 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Gamma-glutamyltransferase increased	14.5% 8/55 • Number of events 8 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Aspartate aminotransferase increased	12.7% 7/55 • Number of events 7 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Weight decreased	12.7% 7/55 • Number of events 7 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Alanine aminotransferase increased	10.9% 6/55 • Number of events 6 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations Electrocardiogram QT prolonged	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Investigations C-reactive protein increased	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Metabolism and nutrition disorders Decreased appetite	25.5% 14/55 • Number of events 14 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Metabolism and nutrition disorders Hypoalbuminaemia	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Metabolism and nutrition disorders Hypokalaemia	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Metabolism and nutrition disorders Hypocalcaemia	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	10.9% 6/55 • Number of events 6 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Musculoskeletal and connective tissue disorders Muscle spasms	10.9% 6/55 • Number of events 6 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Nervous system disorders Headache	12.7% 7/55 • Number of events 7 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Psychiatric disorders Insomnia	7.3% 4/55 • Number of events 4 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	12.7% 7/55 • Number of events 7 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.3% 4/55 • Number of events 4 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Skin and subcutaneous tissue disorders Rash	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Skin and subcutaneous tissue disorders Urticaria	9.1% 5/55 • Number of events 5 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Skin and subcutaneous tissue disorders Purpura	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.5% 3/55 • Number of events 3 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.3% 4/55 • Number of events 4 • From date of the first study drug to 30 ± 3 days after the last dosing of the study drug or before the initiation of new cancer treatment, an average of around 7 months. Other (Not Including Serious) Adverse Events: Adverse events include Serious Adverse Events.

Additional Information

Huya Japan Clinical Development

Huya Japan G.K.

Email: japanclinical@huyabio.com

Results disclosure agreements

• Principal investigator is a sponsor employee HUYABIO International, LLC has agreements with PIs and the agreements restricts the right of the PI to discuss or publish trial results after the trial is completed. The content of disclosure restriction stated in the agreement is "PI shall obtain sponsor's prior written consent before disclosing the information obtained from this clinical trial to a professional society or other external party."
• Publication restrictions are in place

Restriction type: OTHER