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Trial Title:
A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors
NCT ID:
NCT05688605
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
MRG003
HX008
Antibody Drug Conjugate (ADC)
EGFR
Solid tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MRG003+HX008
Description:
Administered intravenously
Arm group label:
MRG003+HX008
Summary:
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and
immunogenicity of MRG003 in combination with HX008 in patients with EGFR-positive
advanced or metastatic solid tumors.
Detailed description:
This study consists of two parts: Phase I and Phase II. The objective of this study is to
assess the safety and tolerability of MRG003 in combination with HX008 in patients with
EGFR-positive advanced or metastatic solid tumors; and to explore the maximum tolerated
dose (MTD) and to determine the recommended phase II dose (RP2D) of combination therapy;
and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of
combination therapy in the targeted study population.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Willing to sign the informed consent form and follow the requirements specified in
the protocol.
2. Aged 18 to 75 (including 18 and 75), both genders.
3. BMI ≥17
4. Life expectancy ≥ 12 weeks.
5. Patients with EGFR-positive advanced or metastatic solid tumors, including non-small
cell lung cancer (NSCLC), squamous cell carcinoma of head and neck (SCCHN), and
nasopharyngeal carcinoma (NPC).
6. EGFR-positive determined by immunohistochemistry (except NSCLC, SCCHN and NPC).
7. Patients must have measurable lesions according to the Response Evaluation Criteria
in Solid Tumors (RECIST v1.1).
8. The score of ECOG for performance status is 0 or 1.
9. No severe cardiac dysfunction.
10. Acceptable liver, renal, and hematologic function.
11. Patients with childbearing potential must use effective contraception during the
treatment and for 6 months after the last dose of treatment.
Exclusion Criteria:
1. History of hypersensitivity to any component of the investigational product.
2. Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy,
investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4
inhibitors/inducers, antibody-drug conjugates, Received major surgery without
complete recovery, etc.
3. Treatment with MMAE/MMAF ADC drugs
4. Central nervous system metastasis.
5. Toxic reaction or abnormal value of laboratory test caused by previous anti-tumor
treatment ≥ 2 (CTCAE v5.0)
6. Presence of peripheral neuropathy ≥ Grade 2.
7. Liver function Child Pugh Grade B or Grade C。
8. Pleural and peritoneal effusion or pericardial effusion with clinical symptoms
requiring drainage.
9. Poorly controlled systemic diseases (hypertension and hyperglycemia, etc.)
10. Evidence of active infection of hepatitis B, hepatitis C or HIV.
11. Patients with poorly controlled heart diseases
12. History of ophthalmic abnormalities.
13. History of severe skin disease requiring oral or intravenous therapy.
14. History of interstitial pneumonia, radiation pneumonia, severe chronic obstructive
pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
15. Active, known or suspected autoimmune disease or drug related immune disease or the
disease history within the past 2 years.
16. The patient is using immunosuppressant or systemic hormone therapy.
17. Patients with any past arteriovenous bleeding within 3 months or current history of
coagulation disorder.
18. Any clinically significant VTE occurred within 6 months.
19. Received allogeneic tissue/solid organ transplantation.
20. Inoculate live vaccine within 30 days before the first dose.
21. Patients with a positive serum pregnancy test or who are breast-feeding or who do
not agree to take adequate contraceptive measures during the treatment and for 180
days after the last dose of study treatment.
22. History of other primary malignant tumor diseases.
23. Investigator considers which not suitable to participate in the clinical trial
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruihua Xu, M.D.
Phone:
86-18127912775
Email:
xurh@sysucc.org.cn
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410029
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yingrui Shi, M.D.
Phone:
13607441956
Email:
shiyingrui@hnca.org.cn
Start date:
June 30, 2022
Completion date:
July 2025
Lead sponsor:
Agency:
Shanghai Miracogen Inc.
Agency class:
Industry
Source:
Shanghai Miracogen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05688605
