Trial Title:
A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT06560138
Condition:
HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
SHR-4602 injection only
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-4602
Description:
SHR-4602 will be administered through IV infusion.
Arm group label:
SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg
Summary:
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-4602
in subjects with HER2-expressing or HER2-mutated locally advanced or metastatic solid
tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to understand the trial procedures and possible adverse events, voluntarily
participate in the trial.
2. ECOG PS score 0 or 1
3. Life expectancy ≥ 12 weeks
4. Adequate bone marrow and other vital organ functions
5. Adequate liver function tests
6. HER 2 exprission advanced solid tumor
Exclusion Criteria:
Inclusion Criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily
participate in the trial.
2. ECOG PS score 0 or 1
3. Life expectancy ≥ 12 weeks
4. Adequate bone marrow and other vital organ functions
5. Adequate liver function tests
6. HER 2 exprission advanced solid tumor
Exclusion Criteria
1. Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.
2. Have received surgery (eg. major surgerical treatment for cancer), chemotherapy,
molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4
weeks prior to the first dose of investigational drug (palliative radiotherapy
within 2 weeks prior to the first dose).
3. Participated in another clinical study with the last dose of study drug received in
less than 4 weeks prior to the first dose.
4. Subjects with toxicities and/or complications from prior treatment not recovered to
NCI-CTCAE Grade ≤ 1.
5. History of pleural fluid, ascites, or pericardial effusion requiring intervention
within 2 weeks prior to the first dose.
6. History of active autoimmune diseases.
7. History of hereditary or acquired bleeding disorders or thrombotic tendency
8. Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] positive
and serum HBV-DNA copy ≥ 500 IU/mL), hepatitis C
9. History of severe infection within the past 30 days, including but not limited to
bacteremia, severe sepsis, pneumonia requiring hospitalization
10. Other malignancies currently or within the past 5 years, except for cured cervical
carcinoma in situ
11. Allergy to any component or excipient of the SHR-4602 product,
12. History of severe medical, psychiatric, or social conditions deemed by the
investigator to be likely to interfere with a subject's ability to understand,
consent, cooperate and participate in the study.
13. Patients with Grade≥2 peripheral neuropathy, except for those with mild symptoms
that do not require treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Scientia Clinical Research Limited
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Contact:
Last name:
Christina Teng, Dr
Phone:
+61 2 9382 5800
Email:
christina.teng@scientiaclinicalresearch.com.au
Investigator:
Last name:
Christina Teng, Dr
Email:
Principal Investigator
Facility:
Name:
Macquarie University
Address:
City:
Sydney
Zip:
2109
Country:
Australia
Contact:
Last name:
John Park, Dr
Phone:
0298122956
Email:
john.park@mqhealth.org.au
Investigator:
Last name:
John Park, Dr
Email:
Principal Investigator
Facility:
Name:
Icon Cancer Centre South Brisbane
Address:
City:
Brisbane
Zip:
4101
Country:
Australia
Contact:
Last name:
Jermaine Coward, Dr
Phone:
61737374500
Email:
Jim.coward@icon.team
Investigator:
Last name:
Jermaine Coward, Dr
Email:
Principal Investigator
Facility:
Name:
Cancer Research SA
Address:
City:
Adelaide
Zip:
500
Country:
Australia
Contact:
Last name:
Rohit Joshi, A/Prof
Phone:
08 8359 2565
Email:
rjoshi@crsa.au
Investigator:
Last name:
Rohit Joshi
Email:
Principal Investigator
Facility:
Name:
Peninsula & South Eastern Haematology and Oncology Group
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Contact:
Last name:
Vinod Ganju, Dr
Phone:
0397815244
Email:
vg@paso.com.au
Investigator:
Last name:
Vinod Ganju, Dr
Email:
Principal Investigator
Start date:
November 15, 2024
Completion date:
September 12, 2026
Lead sponsor:
Agency:
Atridia Pty Ltd.
Agency class:
Industry
Source:
Atridia Pty Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06560138
