Trial Title:
A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors
NCT ID:
NCT06322095
Condition:
Patients With Advanced Solid Tumor
Advanced Solid Tumor With Oncogenic Driver Mutations
Conditions: Official terms:
Neoplasms
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1
Description:
Previous PD-1
Arm group label:
'GH21+PD-1'Group
Intervention type:
Drug
Intervention name:
MET inhibitor
Description:
Previous MET inhibitor
Arm group label:
'GH21+MET Inhibitor'Group
Intervention type:
Drug
Intervention name:
ALK inhibitor
Description:
Previous ALK inhibitor
Arm group label:
'GH21+ALK Inhibitor'Group
Intervention type:
Drug
Intervention name:
BRAF Inhibito
Description:
Previous BRAF inhibitor
Arm group label:
'GH21+BRAF Inhibitor+MEK Inhibitor'Group
Intervention type:
Drug
Intervention name:
EGFR Monoclonal antibody
Description:
Previous EGFR Monoclonal antibody
Arm group label:
'GH21+EGFR Monoclonal Antibody'Group
Intervention type:
Drug
Intervention name:
GH21
Description:
Oral, 15mg BIW or 6mg QD
Arm group label:
'GH21+ALK Inhibitor'Group
Arm group label:
'GH21+BRAF Inhibitor+MEK Inhibitor'Group
Arm group label:
'GH21+EGFR Monoclonal Antibody'Group
Arm group label:
'GH21+MET Inhibitor'Group
Arm group label:
'GH21+PD-1'Group
Intervention type:
Drug
Intervention name:
MEK Inhibitor
Description:
Previous MEK Inhibitor
Arm group label:
'GH21+BRAF Inhibitor+MEK Inhibitor'Group
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects or their legal representatives can understand and voluntarily sign the
written ICF (before the start of screening and any study procedures);
2. Male or female subjects aged ≥18 years;
3. Patients with advanced solid tumors confirmed by cytological or histological
assessments;
4. 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);
5. Life expectancy of ≥ 3 months;
6. ECOG PS score of 0-1;
7. The subjects must have adequate organ functions;
8. 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.
Exclusion Criteria:
1. 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.
2. Subjects who have had another investigational new drug or therapy within 4 weeks
prior to the first dose of the investigational product;
3. 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;
4. 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;
5. 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;
6. 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;
7. Subjects with Uncontrolled pleural effusion, pericardial effusion, or pleural
effusion requiring repeated drainage (once a month or more frequently);
8. 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.);
9. Subjects with interstitial pneumonia, or any evidence of clinically active
interstitial lung disease within 6 months before the first dose of the
investigational product;
10. 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;
11. 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);
12. Subjects with a history of severe allergies, a history of allergies to the
investigational drug/any excipient/combination drug, or to multiple drugs;
13. 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);
14. 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;
15. Subjects with autoimmune diseases in the active phase within 28 days prior to the
first dose of the investigational product;
16. 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;
17. Female subjects who are pregnant or breastfeeding;
18. Subjects who are not suitable for this study due to any clinical or laboratory
abnormalities or other reasons as assessed by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
100029
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning Li, Doctorate
Phone:
（86）010-87788495
Email:
lining@cicams.ac.cn
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yongsheng Wang, Doctorate
Phone:
（86）025-83304616
Email:
dolphin8012@yahoo.com
Start date:
March 22, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Suzhou Genhouse Bio Co., Ltd.
Agency class:
Other
Source:
Suzhou Genhouse Bio Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06322095
