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Trial Title:
A Study of HS248 in Patients With Advanced Solid Tumors
NCT ID:
NCT05759234
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
At this stage, it is planned that HS248 will adopt the traditional "3+3" method of
increasing doses at four dose levels of 20 mg, 40 mg, 60 mg and 80 mg. All dosage
components are divided into single administration stage and multiple administration
stage. After 5 days of observation after single administration, it enters the stage of
multiple administration. In the stage of multiple administration, HS248 is administered
once a day (qd) for 28 days. a treatment cycle. 33 days after the first administration
(the 5-day observation period in the single-administration phase and the first cycle in
the multiple-administration phase) is the dose-limiting toxicity (DLT) observation period
of this study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS248 pieces
Description:
The overall safety and tolerability of PI3Kγ inhibitor monotherapy for solid tumors is
good, and it has shown preliminary clinical benefits. The safety of PI3Kγ inhibitor
combined with immune checkpoint inhibitor is good, and the efficacy of single drug is
significantly improved. Based on the evaluation of the safety and efficacy results of
HS248 preclinical and clinical studies of similar PI3Kγ inhibitors, the benefits of this
product outweigh the risks for patients with advanced solid tumors who have progressed
through standard treatment, have toxicity intolerance, or have no standard treatment
regimen. Sufficient to support planned clinical studies.
Arm group label:
HS248 pieces
Summary:
This study is a non-random, open multi-center study This study is a non-random, open
multi-center phase I study, aimed at evaluation period research, aimed at In the
evaluation phase study, it aims to evaluate the safety, tolerance PK characteristics and
preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. The
study was divided into 2 phases, including dose escalation and dose expansion。
Detailed description:
Main purpose:
Assess the safety and tolerability of HS248 in patients with advanced solid tumors, and
determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of
HS248.
Secondary purpose: Secondary purpose:
Assess the pharmacokinetic (PK) profile of HS248 in patients with advanced solid tumors;
To evaluate the preliminary antitumor activity of HS248 in patients with advanced solid
tumors. Preliminary antitumor activity in patients with advanced solid tumors.
Other purposes:
Population-based PK (PopPK) analysis method, exploratory description) analysis method,
exploratory description) analysis method, exploratory description) analysis method,
exploratory description of HS248 in patients with advanced solid tumors PK features in;
Evaluate the relationship between exposure and efficacy and adverse events (AEs) of HS248
in patients with advanced solid tumors, as data permit; To explore the changes of HS248
in myeloid-derived suppressor cells (MDSC) and CD8+ T cells in patients with advanced
solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily participate in this clinical trial, understand and follow the research
procedures and voluntarily sign the ICF;
2. Male or female, age ≥18 when signing the ICF;
3. Expected survival period ≥ 12 weeks;
4. Patients with advanced solid tumors confirmed by histology/cytology, who have
progressed through standard treatment, have toxicity intolerance, or have no
standard treatment plan (patients with multiple solid tumors are included in the
dose-escalation phase, and the population included in the dose-expansion phase will
be based on dose escalation phase study data and the potential advantageous
population of similar drugs);
5. Eastern Cooperative Oncology Group (ECOG) physical status score 0-1
Exclusion Criteria:
1. Symptomatic or untreated central nervous system metastasis or primary central
nervous system malignancy;
2. Other known malignant tumors in the past 5 years, except cured localized tumors,
including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and
carcinoma in situ of the prostate;
3. Previous history of autoimmune diseases, stem cell transplantation or organ
transplantation;
4. Known drug-induced liver injury, chronic active hepatitis, alcoholic liver disease,
non-alcoholic steatohepatitis, primary biliary cirrhosis, persistent extrahepatic
obstruction caused by gallstones, cirrhosis or portal hypertension;
5. Peptic ulcer and/or gastrointestinal bleeding at present or in the past;
6. Gastrointestinal dysfunction that may limit the absorption of the test drug,
including motility disorders, malabsorption syndrome or inflammatory bowel disease;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Qu Wei
Phone:
0571-8168910X
Phone ext:
9103
Email:
Wei.Qu@hanhui-pharma.com
Investigator:
Last name:
Guo, professor
Email:
Principal Investigator
Start date:
November 15, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Hanhui Pharmaceutical Co., Ltd
Agency class:
Industry
Source:
Hanhui Pharmaceutical Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759234
