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Advanced Malignant TumorPhase 1NCT05851092

Phase I Clinical Study of HRS-2189 in the Treatment of Patients With Advanced Malignant Tumors

A Phase 1 study testing HRS-2189 Tablets in people with Advanced Malignant Tumor, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multi center, open label, dose increasing/dose expanding/efficacy expanding phase I clinical trial aimed at evaluating the safety, tolerance, PK characteristics, and anti-tumor efficacy characteristics of HRS-2189 single drug in patients with advanced malignant solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Tumor
What is being tested?
HRS-2189 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
26 May 2023to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in this study, sign an informed consent form, have good compliance, and can cooperate with follow-up
  • Age ≥ 18 years old (including boundary value, calculated based on the date of signing informed consent), Male or female
  • ECOG score: 0-1
  • Expected survival ≥ 12 weeks
  • Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology and not resectable, and currently fails to undergo standard treatment or has no standard treatment plan
  • If enrolled in ER positive and HER2 negative female breast cancer subjects, they need to meet the criteria defined in the guidelines of the American Association of Clinical Oncology/American College of Pathologists
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  • Baseline presence of at least one extracranial measurable lesion that meets the RECIST v1.1 standard
  • The functional level of important organs is basically normal, meeting the requirements of the scheme
  • Previous treatment: Before the first medication in this study, the interval between receiving nitrosourea or mitomycin C ≥ 6 weeks; Receiving cytotoxic drugs, endocrine therapy, immunotherapy, targeted therapy, surgical interval (except puncture biopsy or PICC catheterization or PORT infusion port catheterization) or other clinical studies with the last medication ≥ 4 weeks; Interval from the end of radiotherapy ≥ 2 weeks
  • Adverse events caused by other treatments for the subject returned to a severity level of NCI-CTCAE V5.0 ≤ 1 (excluding hair loss and other adverse events judged tolerable by the investigator)
  • Female subjects with fertility must agree to use highly effective contraception during the study treatment period and within 7 months after the last medication; Male subjects must agree to use highly effective contraception during the study treatment period and 4 months after the last medication; Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation. If the serum HCG is weakly positive, it is necessary for the researcher to evaluate and judge it as a non pregnant state, and urine HCG should be tested before medication, with a negative result
  • Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent

Who cannot join

  • Subjects with cancerous meningitis or untreated central nervous system metastasis
  • Uncontrolled pleural, abdominal, and pericardial effusion
  • Clinical symptoms or diseases of the heart that are not well controlled
  • Arterial/venous thrombotic events occurred within 6 months before the first medication administration
  • Active infection or unexplained fever>38.5 ° C occurred within 4 weeks before or on the day of the first medication (subjects with tumor fever are judged by the investigator to be included in the study)
  • Subjects with congenital or acquired immune dysfunction (such as HIV infected persons); Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
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  • Subject has active hepatitis
  • Subjects had other malignant tumors within the past 3 years, except for fully treated basal or squamous cell skin cancer or cervical carcinoma in situ
  • Those who are unable to swallow tablets normally or have gastrointestinal dysfunction that may affect drug absorption according to the judgment of the researcher
  • Patients participating in the QT/QTc study have used any medication that has the risk of prolonging the QT/QTc interval or causing torsade de pointe (TdP) within 4 weeks before the first medication, have a previous history of congenital QT interval prolongation syndrome or a family history of QT interval prolongation, have an implanted pacemaker or automatic implantable cardioverter defibrillator, and cannot correct electrolyte disturbances that affect the QT/QTc study
  • Pregnant and lactating women, or planning to become pregnant during the study period
  • According to the judgment of the researcher, the subject has other factors that may lead to the forced termination of this study

Trial locations and contacts

1 site in 1 country.

Xia Zhang contact

+86-0518-81220121

xia.zhang@hengrui.com

China1 site, 1 recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang

    Recruiting

Other trials in China

About this study

Official title: A Single Arm, Open, Multicenter Phase I Clinical Study on the Safety, Tolerance, and Pharmacokinetics of HRS-2189 Single Drug in Patients With Advanced Malignant Solid Tumors

This study is a multi center, open label, dose increasing/dose expanding/efficacy expanding phase I clinical trial aimed at evaluating the safety, tolerance, PK characteristics, and anti-tumor efficacy characteristics of HRS-2189 single drug in patients with advanced malignant solid tumors. This study was divided into three stages: dose escalation, dose expansion, and efficacy expansion.

Being tested
HRS-2189 Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-2189 TabletsDrug

    HRS-2189 Tablets

Study groups in NCT05851092
Study groupRoleWhat they receive
HRS-2189 TabletsExperimentalNot described
Receives: Drug: HRS-2189 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs+SAEs

    Measured: from the first drug administration to within 30 days for the last treatment dose

  2. Dose limited toxicity (DLT) of HRS-2189

    Measured: up to 35 days

  3. Maximum tolerated dose（MTD）of HRS-2189

    Measured: up to 35 days

  4. Recommended Phase II Dose (RP2D) of HRS-2189

    Measured: up to 35 days

Secondary outcomes (14)

  1. Evaluation of pharmacokinetic parameter of HRS-2189: Cmax

    Measured: 2 months

  2. Evaluation of pharmacokinetic parameter of HRS-2189: Tmax

    Measured: 2 months

  3. Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-t

    Measured: 2 months

  4. Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-inf

    Measured: 2 months

  5. Evaluation of pharmacokinetic parameter of HRS-2189: Cmax,ss

    Measured: 2 months

  6. Evaluation of pharmacokinetic parameter of HRS-2189: Tmax,ss

    Measured: 2 months

  7. Evaluation of pharmacokinetic parameter of HRS-2189: Cmin,ss

    Measured: 2 months

  8. Evaluation of pharmacokinetic parameter of HRS-2189: AUCss

    Measured: 2 months

  9. Evaluation of pharmacokinetic parameter of HRS-2189: Rac

    Measured: 2 months

  10. Bioavailability of HRS-2189 on an empty stomach and after meals

    Measured: up to 9 days

  11. Objective Response Rate (ORR)

    Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI

    Measured: every 8 weeks since Day 8 administration,an average of 1 year

  12. Duration of response (DoR)

    Time from documentation of tumor response to disease progression assessed among patients who had an objective response

    Measured: every 8 weeks since Day 8 administration,an average of 1 year

  13. Disease control rate (DCR)

    Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

    Measured: every 8 weeks since Day 8 administration,an average of 1 year

  14. Progression free survival（PFS）

    The time from enrollment to the progression of tumors (in any aspect) or death (for any reason)

    Measured: every 8 weeks since Day 8 administration,an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start26 May 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05851092
Sponsor's protocol ID
HRS-2189-I-101
Status last verified
Apr 2023
First submitted
24 Apr 2023
Last updated
7 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-2189 Tablets in people with Advanced Malignant Tumor, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xia Zhang (+86-0518-81220121, xia.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs+SAEs (time frame: from the first drug administration to within 30 days for the last treatment dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05851092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.

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