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Patients With Advanced Solid TumorPhase 2NCT06322095

A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors

A Phase 2 study testing PD-1, MET inhibitor and ALK inhibitor in people with Patients With Advanced Solid Tumor and Advanced Solid Tumor With Oncogenic Driver Mutations, run by Suzhou Genhouse Bio Co., Ltd. at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PD-1, MET inhibitor and ALK inhibitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesChina
Study dates
22 Mar 2024to 31 Dec 2025
Phase
Phase 2
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

  • Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);
  • Male or female subjects aged ≥18 years;
  • Patients with advanced solid tumors confirmed by cytological or histological assessments;
  • Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);
  • Life expectancy of ≥ 3 months;
  • ECOG PS score of 0-1;
  • The subjects must have adequate organ functions;
  • Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 6 months after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product.

Who cannot join

  • Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following:
  • Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product;
  • Oral administration of fluorouracils, small molecule targeted drugs, and Chinese herbal medicines or Chinese patent medicines with antitumor indications within 5 half-lives or 2 weeks before the first dose of the investigational product (whichever is shorter);
  • Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to the first dose of the investigational product (whichever is shorter);
  • Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational product; Note: If the latest anti-tumor therapy before enrollment is only the intended combination therapy, follow-up therapy can be carried out according to the original treatment cycle according to clinical needs, without waiting for elution.
  • Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product;
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  • Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study;
  • Subjects who have received strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives prior to the first dose of the investigational product;
  • Subjects with evidence of the following heart conditions:
  • Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first dose of the investigational product;
  • Grade III-IV heart failure diagnosed according to the cardiac function classification of the New York Heart Association at screening;
  • Echocardiography (ECHO) shows the left ventricular ejection fraction (LVEF) ≤ 50% at screening;
  • QT interval corrected by Fridericia method (QTcF) is ≥ 450 ms (male) or ≥ 470 ms (female) at screening;
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) despite of medication treatment at screening;
  • Subjects with dysphagia, gastrointestinal disorders that affect drug absorption, or other malabsorption conditions, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, delayed gastric emptying, or severe gastrointestinal toxicities that have not resolved to Grade 2 or lower prior to the first dose of the investigational product; or subjects are diagnosed with a clinically significant or acute gastrointestinal disease;
  • Subjects with Uncontrolled pleural effusion, pericardial effusion, or pleural effusion requiring repeated drainage (once a month or more frequently);
  • Subjects with active central nervous system metastasis and/or carcinomatous meningitis (e.g., brain metastases accompanied by central nervous system symptoms, including headache, vomiting and dizziness, etc.);
  • Subjects with interstitial pneumonia, or any evidence of clinically active interstitial lung disease within 6 months before the first dose of the investigational product;
  • Sujects with arteriovenous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), venous thrombosis, and pulmonary embolism, occurred within 6 months before the first dose of the investigational product;
  • Subjects with a history of other malignancies (excluding those deemed eligible by the investigator, such as skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical cancer in situ that have been cured and have not relapsed for 5 years);
  • Subjects with a history of severe allergies, a history of allergies to the investigational drug/any excipient/combination drug, or to multiple drugs;
  • Subjects with hepatitis B virus infection (HBsAg positivity and DNA copies < 100 IU/mL); or hepatitis C virus infection (HCV antibody positivity, and HCV RNA > ULN); or human immunodeficiency virus infection (HIV antibody positivity); or infected with treponema pallidum (defined as TP-Ab positive);
  • Subjects with active infections requiring anti-infective treatment (Grade ≥ 2) or fever > 38°C of unknown etiology within 28 days prior to the first dose of the investigational product;
  • Subjects with autoimmune diseases in the active phase within 28 days prior to the first dose of the investigational product;
  • Subjects with any toxicity caused by a previous antitumor therapy that has not resolved to Grade ≤ 1 according to CTCAE 5.0 (except for alopecia, Grade 2 peripheral neuropathy, and/or other Grade ≤ 2 AEs of insignificant safety risks) before the first dose of the investigational product;
  • Female subjects who are pregnant or breastfeeding;
  • Subjects who are not suitable for this study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.

Trial locations and contacts

2 sites in 1 country.

Yiming Zhou, Bachelor contact

+86-512-86861608

zhouyiming@genhousebio.com

China2 sites, 2 recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100029

    Ning Li, Doctorate, （86）010-87788495, lining@cicams.ac.cn

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Yongsheng Wang, Doctorate, （86）025-83304616, dolphin8012@yahoo.com

    Not yet recruiting

Other trials in China

About this study

Official title: An Open Exploratory Study to Evaluate The Preliminary Efficacy of GH21 Combined With Primary Targeting or Immunotherapy in Patients With Advanced Solid Tumors Which Targeted or Immunotherapy Has Progressed

This study is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors.

Read the detailed description

This study preset two dose groups, dose group 1 is GH21 15 mg (BIW, D1D2) combined with ALK inhibitor, or MET inhibitor, or BRAF inhibitor +MEK inhibitor, or PD-1 inhibitor, or EGFR monoantibody, or other drugs such as FGFR inhibitor, and it is planned to enroll up to 36 subjects. Dose group 2 was GH21 6 mg (QD) combined with ALK inhibitor, or MET inhibitor, or BRAF inhibitor +MEK inhibitor, or PD-1 inhibitor, or EGFR monoclonal antibody, or other drugs such as FGFR inhibitor, and was planned to enroll up to 36 subjects.

Being tested
PD-1, MET inhibitor, ALK inhibitor, BRAF Inhibito, EGFR Monoclonal antibody

What participants receive

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

  • PD-1Drug

    Previous PD-1

  • MET inhibitorDrug

    Previous MET inhibitor

  • ALK inhibitorDrug

    Previous ALK inhibitor

  • BRAF InhibitoDrug

    Previous BRAF inhibitor

  • EGFR Monoclonal antibodyDrug

    Previous EGFR Monoclonal antibody

  • GH21Drug

    Oral, 15mg BIW or 6mg QD

  • MEK InhibitorDrug

    Previous MEK Inhibitor

Study groups in NCT06322095
Study groupRoleWhat they receive
'GH21+PD-1'GroupExperimentalGH21 combined with previous PD-1.
Receives: Drug: PD-1; Drug: GH21
'GH21+ALK Inhibitor'GroupExperimentalGH21 combined with previous ALK inhibitor.
Receives: Drug: ALK inhibitor; Drug: GH21
'GH21+MET Inhibitor'GroupExperimentalGH21 combined with previous MET inhibitor.
Receives: Drug: MET inhibitor; Drug: GH21
'GH21+BRAF Inhibitor+MEK Inhibitor'GroupExperimentalGH21 combined with previous BRAF inhibitor and MEK inhibitor.
Receives: Drug: BRAF Inhibito; Drug: GH21; Drug: MEK Inhibitor
'GH21+EGFR Monoclonal Antibody'GroupExperimentalGH21 combined with previous EGFR Monoclonal Antibody.
Receives: Drug: EGFR Monoclonal antibody; Drug: GH21

What is being measured

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

  1. Objective Response Rate (ORR) Based on RECIST 1.1 Criteria

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR).

    Measured: 3 years

Secondary outcomes (7)

  1. Number of Participants with Adverse Events

    All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments.

    Measured: 3 years

  2. Duration of Response (DOR) Based on RECIST 1.1 Criteria

    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy termination, to disease progression or death due to any cause, whichever occurs first.

    Measured: 3 years

  3. Disease Control Rate (DCR）Based on RECIST 1.1 Criteria

    DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).

    Measured: 3 years

  4. Progression-Free Survival (PFS) Based on RECIST 1.1 Criteria

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.

    Measured: 3 years

  5. Plasma Peak Concentration (Cmax)

    Highest observed plasma concentration of GH21.

    Measured: 3 years

  6. Time to Achieve Cmax (Tmax)

    Time of highest observed plasma concentration of GH21.

    Measured: 3 years

  7. Area under the Plasma Concentration-Time Curve (AUC)

    Area under the plasma concentration-time curve of GH21.

    Measured: 3 years

Timeline

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

  1. First posted20 Mar 2024
  2. Study start22 Mar 2024
  3. Primary completion30 Sep 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06322095
Sponsor's protocol ID
GH21C202
Status last verified
Mar 2024
First submitted
12 Mar 2024
Last updated
1 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1, MET inhibitor and ALK inhibitor in people with Patients With Advanced Solid Tumor and Advanced Solid Tumor With Oncogenic Driver Mutations, run by Suzhou Genhouse Bio Co., Ltd. at 2 sites 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 8 inclusion and 27 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Yiming Zhou, Bachelor (+86-512-86861608, zhouyiming@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Based on RECIST 1.1 Criteria (time frame: 3 years). 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 NCT06322095.

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 1 Oct 2024.

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