An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers
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ClinicalTrials.gov Identifier: NCT02648490 |
Recruitment Status :
Completed
First Posted : January 7, 2016
Last Update Posted : July 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumour | Drug: HLX07 Drug: Acetaminophen Drug: dexamethasone Drug: diphenhydramine Drug: 5-HT3 inhibitor | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
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:
Drug: diphenhydramine diphenhydramine 30 mg intravenous infusion for 10 minutes before the infusion of HLX07.
Other Names:
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 |
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
- 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 |
Inclusion Criteria:
- Histologically-confirmed, unidimensionally-measurable and/or evaluable carcinoma which has failed standard therapy or for whom no standard therapy is available.
- ECOG performance status score of ≤ 2 at study entry.
- Able to provide written informed consent.
- 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.
- 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
- Adequate renal function as defined by a serum creatinine level within normal limits.
- Use of effective contraception if procreative potential exists.
- Life expectancy of approximately 3 months or longer in the opinion of the investigator.
Exclusion Criteria:
- 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.
- 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.
- 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).
- 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.
- Any condition that prevents the patient from providing informed consent.
- Pregnancy (confirmed by serum beta human chorionic gonadotropin [beta-HCG]) or breast-feeding.
- Any investigational agent(s) or device(s) within 4 weeks of study entry.
- 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.
- Tumor cells with either K-ras, N-ras or B-raf mutations.
- Known history of human immunodeficiency virus infection.
- 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.

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
United States, California | |
Henlix, Inc. | |
Fremont, California, United States, 94538 | |
Taiwan | |
Linkou Chang Gung Memorial Hospital | |
Taoyuan, Taiwan |
Principal Investigator: | Weidong Jiang, Ph.D. | Henlix, Inc |
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 |
metastatic or recurrent epithelial cancer |
Acetaminophen Diphenhydramine Promethazine Dexamethasone Ondansetron 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 Analgesics, Non-Narcotic Analgesics Sensory System Agents Antipyretics Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |