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An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02648490
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Henlix, Inc

Brief Summary:
This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer who have failed standard therapy and deemed unamenable by conventional therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX07 and explore the potential prognostic and predictive biomarkers.

Condition or disease Intervention/treatment Phase
Solid Tumour Drug: HLX07 Drug: Acetaminophen Drug: dexamethasone Drug: diphenhydramine Drug: 5-HT3 inhibitor Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label, dose-escalation study of HLX07 ,3+3 design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective,Open-label, Dose Escalation Phase 1 Study to Investigate the Safety, and Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of a HLX07, in Patients With Advanced Solid Cancers.
Study Start Date : September 2016
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Arm Intervention/treatment
Experimental: HLX07, in patients with solid cancers.

Each cycle of treatment consists of 4 weeks. Patients who enroll into this study will receive weekly infusion of assigned dose of HLX07. No intra-patient dose escalation is allowed.The proposed dose escalation sequence is 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg.

Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07, followed by dexamethasone 10 mg intravenous infusion for 10 minutes, and followed by diphenhydramine 30 mg intravenous infusion for 10 minutes. If the patient experience grade 2 or 3 nausea and vomiting during the first infusion of HLX07, the addition of 5-HT3 inhibitor may be included in the premedication before subsequent infusions.

Drug: HLX07
recombinant human anti-EGFR monoclonal antibody against cancers
Other Name: anti-EGFR monoclonal antibody

Drug: Acetaminophen
Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07.
Other Name: Tylenol

Drug: dexamethasone
dexamethasone 10 mg intravenous infusion for 10 minutes before the infusion of HLX07.
Other Names:
  • Decadron
  • Dexasone

Drug: diphenhydramine
diphenhydramine 30 mg intravenous infusion for 10 minutes before the infusion of HLX07.
Other Names:
  • Allermax
  • Benadryl

Drug: 5-HT3 inhibitor
If the patient experience grade 2 or 3 nausea and vomiting during the first infusion of HLX07, the addition of 5-HT3 inhibitor may be included in the premedication before subsequent infusions.
Other Name: Ondansetron




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related pathological Complete Response assessed using RECIST 1.1 criteria. [ Time Frame: 1 year ]
    Patients will receive CT/MRI imaging studies every 8 weeks for treatment response until disease progression, withdrawal from the study or death, whichever occurs first.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed, unidimensionally-measurable and/or evaluable carcinoma which has failed standard therapy or for whom no standard therapy is available.
  2. ECOG performance status score of ≤ 2 at study entry.
  3. Able to provide written informed consent.
  4. White blood cell (WBC) count ≥3 x 109/L;an absolute neutrophil count ≥ 1.5 x 109/L;a hemoglobin level > 90 g/L; and a platelet count ≥ 100 x 109/L.
  5. Adequate hepatic function as defined by: alkaline phosphatase level ≤ 5.0 x the ULN, bilirubin level ≤ 1.5 x the ULN, aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN for patients with liver metastases
  6. Adequate renal function as defined by a serum creatinine level within normal limits.
  7. Use of effective contraception if procreative potential exists.
  8. Life expectancy of approximately 3 months or longer in the opinion of the investigator.

Exclusion Criteria:

  1. Chemotherapy, radiation, and/or hormonal therapy (except palliative radiation therapy for disease-related pain and chronic hormonal therapy for prostate carcinoma) within 4 weeks of study entry.
  2. Concurrent unstable or uncontrolled medical disease (e.g., active uncontrolled systemic infection, poorly controlled hypertension or history of poor compliance with an anti-hypertensive regimen, unstable angina, congestive heart failure, uncontrolled diabetes) or other chronic disease, which, in the opinion of the investigator, could compromise the patient or the study.
  3. Newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids; anticonvulsants are allowed).
  4. Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for more than 3 years will be allowed to enter the trial.
  5. Any condition that prevents the patient from providing informed consent.
  6. Pregnancy (confirmed by serum beta human chorionic gonadotropin [beta-HCG]) or breast-feeding.
  7. Any investigational agent(s) or device(s) within 4 weeks of study entry.
  8. Prior treatment with cetuximab, or any other anti-EGFR monoclonal antibody therapy for less than 3 months. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted if the drug has been discontinued more than (include) 4 weeks prior to study entry.
  9. Tumor cells with either K-ras, N-ras or B-raf mutations.
  10. Known history of human immunodeficiency virus infection.
  11. Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648490


Locations
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United States, California
Henlix, Inc.
Fremont, California, United States, 94538
Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Henlix, Inc
Investigators
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Principal Investigator: Weidong Jiang, Ph.D. Henlix, Inc

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Responsible Party: Henlix, Inc
ClinicalTrials.gov Identifier: NCT02648490    
Other Study ID Numbers: HLX07FIH
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Henlix, Inc:
metastatic or recurrent epithelial cancer
Additional relevant MeSH terms:
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Acetaminophen
Diphenhydramine
Promethazine
Dexamethasone
Dexamethasone acetate
Cetuximab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antipyretics
Antipruritics
Dermatologic Agents
Neurotransmitter Agents
Central Nervous System Depressants
Sleep Aids, Pharmaceutical