A Study for HSK39775 in Participants With Solid Tumors

March 13, 2024 updated by: Xizang Haisco Pharmaceutical Co., Ltd

A Phase I/II Study to Assess the Safety, Tolerability, PK/PD, and Preliminary Efficacy of HSK39775 Tablet Monotherapy in Participants With Advanced Solid Malignancies

This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
243

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fundan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years or older at screening
  2. Histological or cytological confirmation of advanced malignancy, have failed or intolerant to the standard-of-care treatment or no standard therapy is recognized or standard therapy is unavailable
  3. Eastern Cooperative Oncology Group performance status 0 or 1
  4. Patients must have evaluable disease as defined
  5. Life expectancy of ≥ 12 weeks
  6. Adequate organ and bone marrow function per protocol
  7. Female patients who are women of childbearing potential with confirmed of a negative pregnancy test within 7 days prior to the first dose and agreement to the use of effective contraceptive method at the same time during study treatment period and for up to 6 months after the last dose of study treatment. Male patients must be willing to use effective contraception during the study treatment period and for up to 6 months after the last dose of study treatment
  8. Written informed consent must be obtained

Exclusion Criteria:

  1. Known allergies to HSK39775 or its excipients
  2. Prior anticancer treatment is ineligible per protocol
  3. Subjects who have had continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent within 4 weeks prior to the first dose of study treatment
  4. Subjects who have had live vaccine within 4 weeks prior the first dose of study treatment
  5. Currently participating in a study of another investigational agent or device
  6. Subjects who have had received another agent with same target
  7. Subjects who have not recovered (to grade ≤1 or baseline) from toxicities related to prior therapies
  8. Subjects who have had received drugs that may have drug-drug interaction potential within 4 weeks or 5 half-lives prior to the first dose of study treatment
  9. Subjects who have had received major surgery within 4 weeks prior the first dose of study treatment
  10. Central nervous system metastases associated with neurological symptoms
  11. Active hepatitis B or hepatitis C infection
  12. A history of immunodeficiency
  13. Clinically relevant cardiovascular disease as delined by protocol
  14. Inability to swallow the formulated product or impairment of GI function or disease that may significantly alter the absorption of study drug
  15. A female patient who is pregnant or lactating
  16. Other conditions, in investigator's opinion, not suitable to participate in the clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation
Dose Escalation:Participants will receive escalating doses of HSK39775
Drug: HSK39775 Monotherapy
HSK39775 will be administered orally once daily
Experimental: Cohort Expansion
Cohort Expansion:Participants will receive HSK39775 at the identified RP2D
Drug: HSK39775 Monotherapy
HSK39775 will be administered orally once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AE/SAE
Time Frame: From time of informed consent to 28 days post last dose or start of other anti-cancer therapies
Safety data
From time of informed consent to 28 days post last dose or start of other anti-cancer therapies
DLT
Time Frame: From the start of first dose to the end of Cycle1(each cycle is 28 days)
Safety data
From the start of first dose to the end of Cycle1(each cycle is 28 days)
MTD/MAD
Time Frame: From the start of first dose to the end of Cycle1(each cycle is 28 days)
Safety data
From the start of first dose to the end of Cycle1(each cycle is 28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum Plasma Concentration [Cmax]
Time Frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
At predefined intervals throughout the treatment period(approximately 12 weeks)
Area Under Curve[AUC]
Time Frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
At predefined intervals throughout the treatment period(approximately 12 weeks)
Time to maximum observed concentration [Tmax]
Time Frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
At predefined intervals throughout the treatment period(approximately 12 weeks)
Elimination half-life [t1/2]
Time Frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
At predefined intervals throughout the treatment period(approximately 12 weeks)
Overall Response Rate (ORR) per RECIST V1.1
Time Frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Progression Free Survival
Time Frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Time To Response
Time Frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Disease Control Rate
Time Frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Best percentage change in target lesion
Time Frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xizang Haisco Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSK39775-101/201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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