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A Study of HS248 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05759234
Recruitment Status : Recruiting
First Posted : March 8, 2023
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Hanhui Pharmaceutical Co., Ltd

Study Description
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Brief 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。

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: HS248 pieces Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HS248 in the Treatment of Patients With Advanced Solid Tumors
Actual Study Start Date : November 15, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: HS248 pieces
dose escalation period： 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
 Drug: HS248 pieces
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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: From first dose of HS248 through 28 days after the last HS248 treatment (up to 2 years); each cycle is 28 days ]
    To examine the incidence of clinical and laboratory adverse events after multiple doses of HS-248 in the dose escalation and dose expansion phases

  2. MTD and/or RP2DP2D [ Time Frame: The end of the study is defined as the last subject completing the last visit, study treatment for 2 years, loss to follow-up, death or withdrawal of informed consent, whichever occurs first ]
    MTD and/or RP2DP2D


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: From date of initial dose until up to 33 days for treatment ]
    Cmax of HS248

  2. Area Under the Plasma Concentration versus Time Curve (AUC) [ Time Frame: From date of initial dose until up to 33 days for treatment ]
    AUC of HS248

  3. ORR [ Time Frame: Up to 2 years ]
    Objective Response Rate

  4. DOR [ Time Frame: Up to 2 years ]
    Duration of Remission

  5. PFS [ Time Frame: Up to 2 years ]
    Progression-Free Survival

  6. DCR [ Time Frame: Up to 2 years ]
    Disease Control Rate

  7. OS [ Time Frame: Up to 2 years ]
    Overall Survival


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05759234


Contacts
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Contact: Guo, professor 0571-8168910X ext 9103 Wei.Qu@hanhui-pharma.com
Contact: Tang, MD&PhD 0571-8168910X ext 9103 Wenping.Wang@hanhui-pharma.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Contact: Qu Wei    0571-8168910X ext 9103    Wei.Qu@hanhui-pharma.com   
Principal Investigator: Guo, professor         
Sponsors and Collaborators
Hanhui Pharmaceutical Co., Ltd
More Information
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Responsible Party: Hanhui Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT05759234    
Other Study ID Numbers: HS248-I-01
First Posted: March 8, 2023    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms