Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors (NCT NCT04198818)
NCT ID: NCT04198818
Last Updated: 2024-07-19
Results Overview
MTD estimation: After the escalation is completed, select the MTD based on the isotonic regression. Specifically, select the MTD for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, select the higher dose level when the isotonic estimate is lower than the target toxicity rate and select the lower dose level when the isotonic estimate is greater than or equal to the target toxicity rate.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Up to 1 cycle (21 days)
Results posted on
2024-07-19
Participant Flow
Participant milestones
| Measure |
HH2710 25mg BID
administered orally，25mg QD at C1D1, then 25mg BID from C1D2 (21 days/cycle).
|
HH2710 50mg BID
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
administered orally，100mg BID(21 days/cycle)。
|
HH2710 300mg QD
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
administered orally，800mg QD (21 days/cycle)
|
HH2710 200mg BID
administered orally，200mg BID (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
25mg BID
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
25mg BID
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
25mg BID
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
50mg BID
STARTED
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
50mg BID
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
50mg BID
NOT COMPLETED
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
100mg BID
STARTED
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
100mg BID
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
100mg BID
NOT COMPLETED
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
300mg QD
STARTED
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
300mg QD
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
300mg QD
NOT COMPLETED
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
400mg QD
STARTED
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
|
400mg QD
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
400mg QD
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
|
600mg QD
STARTED
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
|
600mg QD
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
600mg QD
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
|
800mg QD
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
800mg QD
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
800mg QD
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
200mg BID
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
|
200mg BID
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
200mg BID
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors
Baseline characteristics by cohort
| Measure |
HH2710 25mg BID
n=3 Participants
administered orally，25mg QD at C1D1, then 25mg BID from C1D2 (21 days/cycle.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 Participants
administered orally，100mg BID(21 days/cycle)。
|
HH2710 200mg BID
n=7 Participants
administered orally，200mg BID(21 days/cycle)。
|
HH2710 300mg QD
n=4 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=8 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 Participants
administered orally，800mg QD (21 days/cycle)
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
51 years
n=7 Participants
|
55 years
n=5 Participants
|
57 years
n=4 Participants
|
55 years
n=21 Participants
|
63 years
n=8 Participants
|
62 years
n=8 Participants
|
54 years
n=24 Participants
|
57 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Height
|
170.10 cm
n=5 Participants
|
173.40 cm
n=7 Participants
|
173.30 cm
n=5 Participants
|
161.40 cm
n=4 Participants
|
168.05 cm
n=21 Participants
|
161.90 cm
n=8 Participants
|
167.50 cm
n=8 Participants
|
167.75 cm
n=24 Participants
|
167.40 cm
n=42 Participants
|
|
Weight
|
78.97 kg
STANDARD_DEVIATION 24.568 • n=5 Participants
|
68.83 kg
STANDARD_DEVIATION 12.744 • n=7 Participants
|
78.75 kg
STANDARD_DEVIATION 13.550 • n=5 Participants
|
65.29 kg
STANDARD_DEVIATION 7.370 • n=4 Participants
|
88.30 kg
STANDARD_DEVIATION 23.527 • n=21 Participants
|
65.15 kg
STANDARD_DEVIATION 17.241 • n=8 Participants
|
69.21 kg
STANDARD_DEVIATION 17.960 • n=8 Participants
|
74.38 kg
STANDARD_DEVIATION 20.852 • n=24 Participants
|
72.44 kg
STANDARD_DEVIATION 17.098 • n=42 Participants
|
|
BMI
|
26.57 kg/m2
STANDARD_DEVIATION 8.693 • n=5 Participants
|
22.80 kg/m2
STANDARD_DEVIATION 5.237 • n=7 Participants
|
26.38 kg/m2
STANDARD_DEVIATION 4.597 • n=5 Participants
|
24.80 kg/m2
STANDARD_DEVIATION 2.749 • n=4 Participants
|
31.58 kg/m2
STANDARD_DEVIATION 10.449 • n=21 Participants
|
24.53 kg/m2
STANDARD_DEVIATION 6.856 • n=8 Participants
|
24.20 kg/m2
STANDARD_DEVIATION 5.182 • n=8 Participants
|
25.58 kg/m2
STANDARD_DEVIATION 1.193 • n=24 Participants
|
25.61 kg/m2
STANDARD_DEVIATION 5.705 • n=42 Participants
|
|
ECOG Performance Status
0
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
|
Tumor Histology type, n (%)
Adenocarcinoma
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
|
Tumor Histology type, n (%)
Carcinoid Carcinoid Carcinoid
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Histology type, n (%)
Endometrioid
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Histology type, n (%)
Invasive Ductal Carcinoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Tumor Histology type, n (%)
Melanoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Tumor Histology type, n (%)
Squamous Cell Carcinoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Histology type, n (%)
other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Tumor Current Stage, n (%)
Stage III
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Current Stage, n (%)
Stage IIIB
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Tumor Current Stage, n (%)
Stage IV
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
|
Tumor Current Stage, n (%)
Stage IVA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Tumor Current Stage, n (%)
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Location of metastases at baseline
Adrenal
|
1 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Axillary Lymph Nodes
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
1 sites
n=5 Participants
|
1 sites
n=4 Participants
|
0 sites
n=21 Participants
|
1 sites
n=8 Participants
|
1 sites
n=8 Participants
|
1 sites
n=24 Participants
|
5 sites
n=42 Participants
|
|
Location of metastases at baseline
Bladder
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
1 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
0 sites
n=24 Participants
|
2 sites
n=42 Participants
|
|
Location of metastases at baseline
Bone
|
1 sites
n=5 Participants
|
1 sites
n=7 Participants
|
1 sites
n=5 Participants
|
2 sites
n=4 Participants
|
0 sites
n=21 Participants
|
1 sites
n=8 Participants
|
3 sites
n=8 Participants
|
1 sites
n=24 Participants
|
10 sites
n=42 Participants
|
|
Location of metastases at baseline
Bone, Lumbar Vertebrae
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Bone, Sacrum
|
0 sites
n=5 Participants
|
1 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
0 sites
n=24 Participants
|
2 sites
n=42 Participants
|
|
Location of metastases at baseline
Brain
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
2 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
0 sites
n=24 Participants
|
3 sites
n=42 Participants
|
|
Location of metastases at baseline
Cervical Lymph Node
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
3 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
0 sites
n=24 Participants
|
4 sites
n=42 Participants
|
|
Location of metastases at baseline
Colon
|
1 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Kidney
|
1 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
1 sites
n=24 Participants
|
3 sites
n=42 Participants
|
|
Location of metastases at baseline
Liver
|
3 sites
n=5 Participants
|
2 sites
n=7 Participants
|
2 sites
n=5 Participants
|
4 sites
n=4 Participants
|
4 sites
n=21 Participants
|
3 sites
n=8 Participants
|
5 sites
n=8 Participants
|
3 sites
n=24 Participants
|
26 sites
n=42 Participants
|
|
Location of metastases at baseline
Lung
|
0 sites
n=5 Participants
|
3 sites
n=7 Participants
|
2 sites
n=5 Participants
|
5 sites
n=4 Participants
|
3 sites
n=21 Participants
|
1 sites
n=8 Participants
|
7 sites
n=8 Participants
|
4 sites
n=24 Participants
|
25 sites
n=42 Participants
|
|
Location of metastases at baseline
Meninges
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
1 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Omentum
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
1 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Pancreas
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
1 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Pericardial Effusion (Malignant)
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Peritoneum
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
1 sites
n=4 Participants
|
1 sites
n=21 Participants
|
3 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
5 sites
n=42 Participants
|
|
Location of metastases at baseline
Pleura
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
2 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
1 sites
n=8 Participants
|
1 sites
n=24 Participants
|
4 sites
n=42 Participants
|
|
Location of metastases at baseline
Pleural Effusion (Malignant)
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
1 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Spleen
|
0 sites
n=5 Participants
|
1 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
0 sites
n=8 Participants
|
1 sites
n=24 Participants
|
2 sites
n=42 Participants
|
|
Location of metastases at baseline
Stomach
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
0 sites
n=5 Participants
|
0 sites
n=4 Participants
|
0 sites
n=21 Participants
|
1 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
1 sites
n=42 Participants
|
|
Location of metastases at baseline
Thoracic Lymph Nodes
|
0 sites
n=5 Participants
|
0 sites
n=7 Participants
|
1 sites
n=5 Participants
|
1 sites
n=4 Participants
|
0 sites
n=21 Participants
|
0 sites
n=8 Participants
|
0 sites
n=8 Participants
|
0 sites
n=24 Participants
|
2 sites
n=42 Participants
|
|
Location of metastases at baseline
Other
|
3 sites
n=5 Participants
|
2 sites
n=7 Participants
|
4 sites
n=5 Participants
|
6 sites
n=4 Participants
|
1 sites
n=21 Participants
|
2 sites
n=8 Participants
|
3 sites
n=8 Participants
|
3 sites
n=24 Participants
|
24 sites
n=42 Participants
|
|
Number of metastases at baseline
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Number of metastases at baseline
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Number of metastases at baseline
3
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Number of metastases at baseline
>3
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Number of metastases at baseline
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Number of prior lines or regimens of therapy
First Line
|
2 number of lines or regimens
n=5 Participants
|
2 number of lines or regimens
n=7 Participants
|
3 number of lines or regimens
n=5 Participants
|
6 number of lines or regimens
n=4 Participants
|
2 number of lines or regimens
n=21 Participants
|
3 number of lines or regimens
n=8 Participants
|
7 number of lines or regimens
n=8 Participants
|
1 number of lines or regimens
n=24 Participants
|
26 number of lines or regimens
n=42 Participants
|
|
Number of prior lines or regimens of therapy
Second Line
|
2 number of lines or regimens
n=5 Participants
|
2 number of lines or regimens
n=7 Participants
|
3 number of lines or regimens
n=5 Participants
|
6 number of lines or regimens
n=4 Participants
|
2 number of lines or regimens
n=21 Participants
|
3 number of lines or regimens
n=8 Participants
|
5 number of lines or regimens
n=8 Participants
|
0 number of lines or regimens
n=24 Participants
|
23 number of lines or regimens
n=42 Participants
|
|
Number of prior lines or regimens of therapy
Third Line
|
2 number of lines or regimens
n=5 Participants
|
2 number of lines or regimens
n=7 Participants
|
3 number of lines or regimens
n=5 Participants
|
3 number of lines or regimens
n=4 Participants
|
1 number of lines or regimens
n=21 Participants
|
3 number of lines or regimens
n=8 Participants
|
4 number of lines or regimens
n=8 Participants
|
1 number of lines or regimens
n=24 Participants
|
19 number of lines or regimens
n=42 Participants
|
|
Number of prior lines or regimens of therapy
Third Line More
|
1 number of lines or regimens
n=5 Participants
|
2 number of lines or regimens
n=7 Participants
|
3 number of lines or regimens
n=5 Participants
|
2 number of lines or regimens
n=4 Participants
|
1 number of lines or regimens
n=21 Participants
|
2 number of lines or regimens
n=8 Participants
|
3 number of lines or regimens
n=8 Participants
|
0 number of lines or regimens
n=24 Participants
|
14 number of lines or regimens
n=42 Participants
|
|
Number of prior lines or regimens of therapy
Neo-adjuvant
|
0 number of lines or regimens
n=5 Participants
|
0 number of lines or regimens
n=7 Participants
|
0 number of lines or regimens
n=5 Participants
|
1 number of lines or regimens
n=4 Participants
|
0 number of lines or regimens
n=21 Participants
|
0 number of lines or regimens
n=8 Participants
|
0 number of lines or regimens
n=8 Participants
|
1 number of lines or regimens
n=24 Participants
|
2 number of lines or regimens
n=42 Participants
|
|
Number of prior lines or regimens of therapy
Adjuvant
|
0 number of lines or regimens
n=5 Participants
|
0 number of lines or regimens
n=7 Participants
|
0 number of lines or regimens
n=5 Participants
|
3 number of lines or regimens
n=4 Participants
|
1 number of lines or regimens
n=21 Participants
|
0 number of lines or regimens
n=8 Participants
|
3 number of lines or regimens
n=8 Participants
|
1 number of lines or regimens
n=24 Participants
|
8 number of lines or regimens
n=42 Participants
|
|
Number of prior lines or regimens of therapy
Palliative
|
0 number of lines or regimens
n=5 Participants
|
0 number of lines or regimens
n=7 Participants
|
0 number of lines or regimens
n=5 Participants
|
0 number of lines or regimens
n=4 Participants
|
1 number of lines or regimens
n=21 Participants
|
0 number of lines or regimens
n=8 Participants
|
0 number of lines or regimens
n=8 Participants
|
0 number of lines or regimens
n=24 Participants
|
1 number of lines or regimens
n=42 Participants
|
|
Number of prior lines or regimens of therapy
Other
|
1 number of lines or regimens
n=5 Participants
|
1 number of lines or regimens
n=7 Participants
|
1 number of lines or regimens
n=5 Participants
|
2 number of lines or regimens
n=4 Participants
|
1 number of lines or regimens
n=21 Participants
|
1 number of lines or regimens
n=8 Participants
|
1 number of lines or regimens
n=8 Participants
|
2 number of lines or regimens
n=24 Participants
|
10 number of lines or regimens
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 1 cycle (21 days)MTD estimation: After the escalation is completed, select the MTD based on the isotonic regression. Specifically, select the MTD for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, select the higher dose level when the isotonic estimate is lower than the target toxicity rate and select the lower dose level when the isotonic estimate is greater than or equal to the target toxicity rate.
Outcome measures
| Measure |
All Participants
n=37 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
MTD (Maximum Tolerated Dose)
|
NA mg
Insufficient number of participants with events because of the early termination of the study.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 1 cycle (21 days)DLT is defined as: any toxicity meeting the specified criteria and considered at least possibly related to HH2710 (i.e., any toxicity for which a clear alternative etiology such as disease progression has not been identified) should be considered a DLT per National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE V5.0) standard, which met any of the following, NCI-CTCAE V5.0 will be used for all grading, and compliance of 80% (i.e. 17 of 21 days) in Cycle 1 is required for a patient to be included in the DLT evaluation. For the purpose of dose-escalation decisions, DLTs will be considered and included in the BOIN.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=7 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=4 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=8 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced DLT (Dose Limiting Toxicities)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 1 cycle (21 days)ORR=CR+PR. ORR was defined as the percentage of patients who had at least one confirmed response of CR or PR defined by RECIST version 1.1 prior to any evidence of progression, and was calculated and summarized by the treatment group, along with the 95% confidence interval (CI) calculated by the Clopper-Pearson method.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=7 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=4 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=8 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Tumor Objective Response Rate (ORR)
|
0 percentage of patients
Interval 0.0 to 70.8
|
0 percentage of patients
Interval 0.0 to 70.8
|
0 percentage of patients
Interval 0.0 to 60.2
|
0 percentage of patients
Interval 0.0 to 41.0
|
0 percentage of patients
Interval 0.0 to 60.2
|
0 percentage of patients
Interval 0.0 to 60.2
|
0 percentage of patients
Interval 0.0 to 36.9
|
0 percentage of patients
Interval 0.0 to 60.2
|
SECONDARY outcome
Timeframe: C1D1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h;C1D2, pre-dose and 24h; C1D7,C1D10, pre-dose.C1D15 at pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h, C1D16 pre-dose and 24h,C1D22 pre-dose,and C2D1,C3D1,C5D1,C7D1,C9D1 pre-dose.Population: Pharmacokinetic data of HH2710 following a single and multiple dosing administration was evaluated in 35 and 25 patients, respectively.All patients received at least one dose of the study treatment and were included in the FAS and SAS. 35 patients were included in PKS. and group analysis is based on dose administration group.
Measure of time to reach maximum (peak) plasma concentration(s)
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=7 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=3 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=7 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Measures - Peak Time (Tmax)
Single Dose Administration
|
1 h
Interval 0.5 to 3.0
|
2 h
Interval 1.0 to 2.0
|
2.5 h
Interval 1.0 to 24.0
|
2 h
Interval 1.0 to 24.0
|
4 h
Interval 1.0 to 24.0
|
2.5 h
Interval 2.0 to 3.0
|
2 h
Interval 0.5 to 4.0
|
7 h
Interval 3.0 to 8.0
|
|
Pharmacokinetic Measures - Peak Time (Tmax)
Multiple-dose Administration
|
1 h
Interval 1.0 to 24.0
|
1.5 h
Interval 1.0 to 2.0
|
2 h
Interval 2.0 to 2.0
|
3 h
Interval 2.0 to 3.0
|
8 h
Interval 1.0 to 24.0
|
6 h
Interval 2.0 to 8.0
|
4 h
Interval 2.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: C1D1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h;C1D2, pre-dose and 24h; C1D7,C1D10, pre-dose.C1D15 at pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h, C1D16 pre-dose and 24h,C1D22 pre-dose,and C2D1,C3D1,C5D1,C7D1,C9D1 pre-dose.Population: Pharmacokinetic data of HH2710 following a single and multiple dosing administration was evaluated in 35 and 25 patients, respectively.All patients received at least one dose of the study treatment and were included in the FAS and SAS. 35 patients were included in PKS. and group analysis is based on dose administration group.
Measure the maximum (peak) plasma concentration(s)
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=7 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=3 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=7 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Measures - Peak Plasma Concentration (Cmax)
Single Dose Administration
|
281 ng/mL
Standard Deviation 37.1
|
382 ng/mL
Standard Deviation 59.7
|
826 ng/mL
Standard Deviation 66.1
|
1440 ng/mL
Standard Deviation 70.2
|
1389 ng/mL
Standard Deviation 131.1
|
1926 ng/mL
Standard Deviation 82.5
|
3462 ng/mL
Standard Deviation 45.6
|
5313 ng/mL
Standard Deviation 88.0
|
|
Pharmacokinetic Measures - Peak Plasma Concentration (Cmax)
Multiple-dose Administration
|
920 ng/mL
Standard Deviation 77.2
|
1038 ng/mL
Standard Deviation 22.0
|
2115 ng/mL
Standard Deviation 17.1
|
2130 ng/mL
Standard Deviation 61.2
|
1112 ng/mL
Standard Deviation 42.6
|
1933 ng/mL
Standard Deviation 83.3
|
6519 ng/mL
Standard Deviation 6519
|
—
|
SECONDARY outcome
Timeframe: C1D1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h;C1D2, pre-dose and 24h; C1D7,C1D10, pre-dose.C1D15 at pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h, C1D16 pre-dose and 24h,C1D22 pre-dose,and C2D1,C3D1,C5D1,C7D1,C9D1 pre-dose.Population: Pharmacokinetic data of HH2710 following a single and multiple dosing administration was evaluated in 35 and 25 participates, respectively. But the AUC0-t, t1/2, Lambda z (λz) and CL/F of some patients could not be calculated because of insufficient sampling time points after Tmax point during the elimination phase. So the participates analyzed for AUC0-t, t1/2, Lambda z (λz) and CL/F is less than participates of dosing administration.
Measure the variation of concentration in blood plasma as a function of time
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=7 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=3 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=4 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Measures - Plasma Concentration Timecurve From Time 0 to Time (t) (AUC0-t)
Multiple-dose Administration
|
16619 h*ng/mL
Standard Deviation 108.2
|
13738 h*ng/mL
Standard Deviation NA
1 data so no SD.
|
34387 h*ng/mL
Standard Deviation 23.5
|
29611 h*ng/mL
Standard Deviation 91.5
|
17572 h*ng/mL
Standard Deviation 39.6
|
28267 h*ng/mL
Standard Deviation 69.8
|
64857 h*ng/mL
Standard Deviation 95.3
|
—
|
|
Pharmacokinetic Measures - Plasma Concentration Timecurve From Time 0 to Time (t) (AUC0-t)
Single Dose Administration
|
2858 h*ng/mL
Standard Deviation 58.4
|
3139 h*ng/mL
Standard Deviation 52.6
|
7683 h*ng/mL
Standard Deviation 61.0
|
16027 h*ng/mL
Standard Deviation 67.0
|
11369 h*ng/mL
Standard Deviation 87.9
|
20546 h*ng/mL
Standard Deviation 66.7
|
37032 h*ng/mL
Standard Deviation 25.8
|
79134 h*ng/mL
Standard Deviation 64.0
|
SECONDARY outcome
Timeframe: Single dose, C1D1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h(if available),C1D2, pre-dose(if available)Population: AUC0-t, t1/2, Lambda z and CL/F of some patients could not be calculated because of insufficient sampling time points after Tmax point during the elimination phase. So the participates analyzed for AUC0-t, t1/2, Lambda z (λz) and CL/F is less than participates of dosing administration.
Terminal half-life, defined as 0.693 (ln2) divided by Lambda z. And t1/2，Lambda z (λz), Vz/F, are only applicable for single dose administration.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=3 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=3 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=2 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=4 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=2 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Measures -Plasma Elimination Half-life (t1/2)
|
16 h
Standard Deviation 12
|
15.6 h
Standard Deviation 12.6
|
12.2 h
Standard Deviation 6.5
|
37.9 h
Standard Deviation 16.7
|
8.8 h
Standard Deviation 1.1
|
12.4 h
Standard Deviation 3.5
|
8.9 h
Standard Deviation 2.9
|
20.9 h
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Single dose, C1D1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h(if available),C1D2, pre-dose(if available)Population: AUC0-t, t1/2, Lambda z and CL/F of some patients could not be calculated because of insufficient sampling time points after Tmax point during the elimination phase. So the participates analyzed for AUC0-t, t1/2, Lambda z (λz) and CL/F is less than participates of dosing administration.
Terminal phase rate constant, determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve. The correlation coefficient (r2) for the goodness of the fit of the regression line through the data points has to be 0.85 or higher for the value to be considered reliable. If the WinNonlin data points are not on the linear portion of the terminal slope, the data points will be selected manually prior to calculation of Lambda\_z. And t1/2，Lambda z (λz), Vz/F，these 3 PK parameters are only applicable for single dose administration.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=3 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=3 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=2 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=4 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=2 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Measures - Plasma Clearance Rate Constant, Lambda z (λz)
|
6.1 1/h
Standard Deviation 3.7
|
6.4 1/h
Standard Deviation 3.7
|
3 1/h
Standard Deviation 2.6
|
2.2 1/h
Standard Deviation 1.2
|
8 1/h
Standard Deviation 1
|
6 1/h
Standard Deviation 1.6
|
5.4 1/h
Standard Deviation 3.7
|
3.3 1/h
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: C1D1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h ;C1D2, pre-dose and 24h; C1D7,C1D10, pre-dose.C1D15 at pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h, C1D16 pre-dose and 24h,C1D22 pre-dose,and C2D1,C3D1,C5D1,C7D1,C9D1 pre-dose.Population: AUC0-t, t1/2, Lambda z and CL/F of some patients could not be calculated because of insufficient sampling time points after Tmax point during the elimination phase. So the participates analyzed for AUC0-t, t1/2, Lambda z (λz) and CL/F is less than participates of dosing administration.
Measure apparent total clearance(s) from plasma after oral
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=3 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=3 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=4 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=2 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Measures - Apparent Clearance (CL/F)
Single Dose Administration
|
8.2 L/h
Standard Deviation 5.6
|
14.7 L/h
Standard Deviation 9.5
|
9.3 L/h
Standard Deviation 4.7
|
13.6 L/h
Standard Deviation 19.3
|
26.5 L/h
Standard Deviation 21.2
|
23.3 L/h
Standard Deviation 21.6
|
14.4 L/h
Standard Deviation 5
|
4.1 L/h
Standard Deviation 1.6
|
|
Pharmacokinetic Measures - Apparent Clearance (CL/F)
Multiple-dose Administration
|
5.1 L/h
Standard Deviation 3.2
|
5.9 L/h
Standard Deviation 0.1
|
5.5 L/h
Standard Deviation 1.2
|
21.3 L/h
Standard Deviation 18.8
|
18.9 L/h
Standard Deviation 7
|
18.5 L/h
Standard Deviation 8.7
|
6.8 L/h
Standard Deviation 2.8
|
—
|
SECONDARY outcome
Timeframe: Single dose, C1D1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h(if available),C1D2, pre-dose(if available)Population: AUC0-t, t1/2, Lambda z and CL/F of some patients could not be calculated because of insufficient sampling time points after Tmax point during the elimination phase. So the participates analyzed for AUC0-t, t1/2, Lambda z (λz) and CL/F is less than participates of dosing administration.
The apparent volume of distribution during terminal phase (associated with λz)(volume). And t1/2，Lambda z (λz), Vz/F，these 3 PK parameters are only applicable for single dose administration.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants received at least one dose of the study treatment.
|
HH2710 50mg BID
n=3 Participants
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=3 Participants
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=3 Participants
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=2 Participants
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 Participants
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=4 Participants
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=2 Participants
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Measures - Apparent Volume of Distribution (Vz/F)
|
126.5 L
Standard Deviation 30.4
|
218.9 L
Standard Deviation 32.3
|
151.9 L
Standard Deviation 104.7
|
454 L
Standard Deviation 505
|
353 L
Standard Deviation 311.6
|
385 L
Standard Deviation 328
|
184 L
Standard Deviation 82
|
122 L
Standard Deviation 42
|
Adverse Events
HH2710 25mg BID
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
HH2710 50mg BID
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
HH2710 100mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
HH2710 200mg BID
Serious events: 3 serious events
Other events: 7 other events
Deaths: 4 deaths
HH2710 300mg QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
HH2710 400mg QD
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
HH2710 600mg QD
Serious events: 5 serious events
Other events: 8 other events
Deaths: 6 deaths
HH2710 800mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
HH2710 25mg BID
n=3 participants at risk
administered orally，25mg QD at C1D1, then 25mg BID from C1D2 (21 days/cycle).
|
HH2710 50mg BID
n=3 participants at risk
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 participants at risk
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=7 participants at risk
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=4 participants at risk
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 participants at risk
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=8 participants at risk
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 participants at risk
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Renal and urinary disorders
Urinary tract infection bacterial
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Eye disorders
Central serous chorioretinopathy
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Eye disorders
Macular oedema
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
Other adverse events
| Measure |
HH2710 25mg BID
n=3 participants at risk
administered orally，25mg QD at C1D1, then 25mg BID from C1D2 (21 days/cycle).
|
HH2710 50mg BID
n=3 participants at risk
administered orally，50mg BID (21 days/cycle)
|
HH2710 100mg BID
n=4 participants at risk
administered orally，100mg BID(21 days/cycle)
|
HH2710 200mg BID
n=7 participants at risk
administered orally，200mg BID(21 days/cycle)
|
HH2710 300mg QD
n=4 participants at risk
administered orally，300mg QD (21 days/cycle)
|
HH2710 400mg QD
n=4 participants at risk
administered orally，400mg QD (21 days/cycle)
|
HH2710 600mg QD
n=8 participants at risk
administered orally，600mg QD (21 days/cycle)
|
HH2710 800mg QD
n=4 participants at risk
administered orally，800mg QD (21 days/cycle)
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
85.7%
6/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
37.5%
3/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
42.9%
3/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
4/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
42.9%
3/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
75.0%
6/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
57.1%
4/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
2/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
42.9%
3/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
4/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
42.9%
3/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
42.9%
3/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
37.5%
3/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
37.5%
3/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
28.6%
2/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
4/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
2/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
42.9%
3/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
14.3%
1/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
12.5%
1/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
28.6%
2/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Investigations
Bilirubin conjugated increased
|
33.3%
1/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
28.6%
2/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
28.6%
2/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
2/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
28.6%
2/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
50.0%
2/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/3 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
28.6%
2/7 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
1/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
25.0%
2/8 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
0.00%
0/4 • up to 30 days after the last dose administration for each participate, and an average of 24 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place