Overview

The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors.

Status:
Active, not recruiting
Trial end date:
2021-10-30
Target enrollment:
0
Participant gender:
All
Summary
HLX07 is a new anti-EGFR monoclonal antibody (mAb) with improved glycosylation pattern.In pre-clinical efficacy studies, HLX-07 is either equivalent or more potent than cetuximab in multiple cancer models without increased toxicities.This study is an open-labeled, dose-escalation study designed to explore the maximum tolerated dose (MTD) and safety of HLX07 in combination with different chemotherapy regimens.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Henlius Biotech
Treatments:
Albumin-Bound Paclitaxel
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Carboplatin
Cisplatin
Gemcitabine
Immunoglobulins
Oxaliplatin
Paclitaxel
Criteria
Inclusion Criteria:

1. Patients with histologically confirmed metastatic or recurrent advanced solid tumors
which has indication to receive treatment with one of above three chemotherapy
regimens.The lesions must be assessable based on the RECIST v1.1 criteria.The number
of previously received chemotherapy regimens should not exceed two.

2. At least 28 days from prior major surgery, prior cytotoxic chemotherapy, or prior
therapy with investigational agents or local radiotherapy and at least 42 days from
the last infusion of immune check point inhibitors (The antibodies or drugs include
but not limited to IDO, PD-1, PD-L1, IL-2R, CTLA-4, CD137, and GITR) before the first
infusion of investigational product.

3. Eastern Cooperative Oncology Group (ECOG) score ≤ 1,

4. Expected survival time ≥ 3 months;

5. Has sufficient hematological function, defined as: neutrophil absolute value ≥ 1.5 ×
109 / L; hemoglobin level ≥ 9.0 g / dL ; Platelet count ≥100×109 /L.

6. Has sufficient liver function, defined as: total bilirubin level ≤ 1.5 × upper limit
of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
levels ≤ 2.5 × ULN, For patients with known liver metastases or primary hepatocellular
carcinoma patients ≤ 5 x ULN.

7. Has adequate coagulation function defined as: International normalized ratio (INR) ≤
1.5 or prothrombin time (PT) ≤ 1.5 x ULN, and activated partial thromboplastin time
(PTT) in the absence of anticoagulant therapy /aPTT) ≤ 1.5 x ULN.

8. Has adequate cardiac function, defined as: left ventricular ejection fraction (LVEF) ≥
50%.

9. Has sufficient renal function; in patients receiving the gemcitabine plus cisplatin
regimen is defined as creatinine clearance ≥ 60 ml/min and in patients receiving the
paclitaxel plus carboplatin regimen or the mFOLFOX6 regimen, is defined as creatinine
clearance ≥ 50 ml/min (calculated by the Cockcroft-Gault formula).

10. Use of effective contraceptive measures if procreative potential exists.

11. Able to provide written informed consent.

Exclusion Criteria:

1. Concurrent unstable or uncontrolled medical conditions. Either of the followings:

- Active systemic infections;

- Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic
blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;

- Clinically significant arrhythmia, unstable angina pectoris, congestive heart
failure (class III or IV of New York Heart Association (NYHA)) or acute
myocardial infarction within 6 months;

- Uncontrolled diabetes or poor compliance with hypoglycemic agents;

- The presence of chronically unhealed wound or ulcers;

- Other chronic diseases, which, in the opinion of the investigator, could
compromise safety of the patient or the integrity of study.

2. Unstable central nervous system (CNS) metastasis. Patients who have previously
undergone surgery or radiotherapy for brain metastases may participate in this study
if they are clinically stable for at least 4 weeks and has stopped steroids for at
least 2 weeks prior to the first infusion of the test drug and there is no new
evidence of progression.

3. Has primary central nervous system malignancy;

4. Known patients have drug allergies to specific drug regimens (eg anti-EGFR monoclonal
antibodies, gemcitabine, platinum, paclitaxel, fluorouracil allergy);

5. known active hepatitis B or C infection (active hepatitis B is defined as hepatitis B
surface antigen HBsAg positive and Hepatitis B virus (HBV) DNA> 500 copies / ml;
active hepatitis C is defined as hepatitis C antibody-positive and / or quantitative
Hepatitis C virus (HCV) RNA results positive);

6. Human immunodeficiency virus infection .

7. Pregnancy or breast-feeding woman.

8. Patients with colorectal cancer whose tumors have K-ras, N-ras, or B-raf mutations;

9. The patient has a history of alcohol abuse or drug abuse;

10. Use of herbal medicine within the first 2 weeks before the first infusion of the test
drug;

11. Treatment with systemic steroids (equivalent to >10 mg/day of methylprednisolone) or
any other form of immunosuppressive therapy within 2 weeks of the first infusion of
the test drug;

12. Patient has a history or current evidence of any condition or disease that could
confound the results of the study, or is not the best interest of the patient to
participate, in the opinion of Investigator.