A Study of HLX06, a Humanized Monoclonal Antibody Targeting Human Vascular Endothelial Growth Factor Receptor-2 in Patients With Advanced Solid Tumors

NCT03494231 | Terminated Phase 1 FDA Drug

• 1 other identifier: HLX06-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of fully human anti-VEGFR2 monoclonal antibody, HLX06, in patients with advanced or metastatic tumors refractory to standard therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX06 and explore the potential prognostic and predictive biomarkers.

Conditions

Solid Tumor, Adult

Keywords

Metastatic; Refractory; Cancer; Solid; Tumor

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1.5 years

Study Arms (1)

HLX06, in patients with solid cancers

EXPERIMENTAL

Each cycle of treatment consists of 4 weeks. Patients who enroll into this study will receive an infusion of assigned dose of HLX06 once per week. No intra-patient dose escalation is allowed. The proposed dose escalation sequence is 500, 750, 900, 1200, 1500 mg, starting from 500 mg/kg.

Drug: HLX06

Interventions

HLX06 DRUG

recombinant fully human anti-VEGFR2 monoclonal antibody against cancers

Also known as: anti-VEGFR2 monoclonal antibody

HLX06, in patients with solid cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3; a hemoglobin level ≥ 10 gm/dL; a platelet count ≥ 100,000/mm3.
• Adequate hepatic function defined by: a total bilirubin level ≤ 1.5x of upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5x of ULN or ≤ 5x of ULN in known hepatic metastases or with primary hepatocellular carcinoma.
• Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute by Cockcroft-Gault formula.
• Adequate cardiac function defined as left ventricular ejection fraction (LVEF)≥ 50%.
• Use of effective contraceptive measures if procreative potential exists.
• At least 28 days from prior major surgery, prior cytotoxic chemotherapy, or prior therapy with investigational agents (or medical device) or local radiotherapy before 1st infusion of HLX06.
• For patients with hepatocellular carcinoma, their Child-Pugh score has to be A.
• Able to be followed up as required by the study protocol.

You may not qualify if:

• Patients with large centrally located pulmonary lesions adjacent to or invading large blood vessels.
• Hemoptysis more than ½ teaspoon (approximately 2-3 mL) of red blood per day.
• Patients who still have ≥ grade 2 toxicities from prior therapies.
• Concurrent unstable or uncontrolled medical conditions with 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 hypoglycemics;
• 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.
• 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 for brain edema). 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 ≥ 3 years are allowed to participate).
• Pregnancy (confirmed by serum beta human chorionic gonadotropin \[ßHCG\]) or breast-feeding (for female patients only).
• A known history or clinical evidence of a deep vein or arterial thrombosis, or pulmonary embolism within 6 months of first infusion of HLX06.
• Less than six weeks from last infusion of ramucirumab, or any other anti-VEGF monoclonal antibody therapy (Last treatment with other monoclonal antibodies targeting proteins other than anti-angiogenic factors is permitted if ≥ 4 weeks prior to the first infusion of HLX06).

Sponsors & Collaborators

• Henlix, Inc: lead

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tus-Yi Chao, MD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The modified accelerated titration design (ATD) 2A and Bayesian optimal interval design (BOIN)

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: April 11, 2018
• Study Start: March 22, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 30, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

TW (1)