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Phase 1 Study of HLX10, a Monoclonal Antibody Targeting Programmed Death-1 (PD-1) in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03468751
Recruitment Status : Unknown
Verified May 2019 by Henlix, Inc.
Recruitment status was:  Recruiting
First Posted : March 19, 2018
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Henlix, Inc

Brief Summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of humanized anti-PD-1 monoclonal antibody, HLX10, 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 HLX10 and explore the potential prognostic and predictive biomarkers.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: HLX10 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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 HLX10 in Patients With Advanced Solid Tumors
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: HLX10, Dose Finding Cohort
Each cycle of treatment consists of 4 weeks. Patients who enroll into this study will receive an infusion of assigned dose of HLX10 once every two weeks. No intra-patient dose escalation is allowed. The proposed dose escalation sequence is 0.3, 1.0, 3.0, and 10 mg/kg, starting from 0.3 mg/kg.
Drug: HLX10
recombinant humanized anti-PD-1 monoclonal antibody against solid cancers
Other Name: anti-PD-1 monoclonal antibody

Experimental: HLX10, Dose Expansion Cohort (200 mg )
Each cycle of treatment consists of 4 weeks. Patients who enroll into this expansion cohort will receive an infusion of assigned dose of HLX10 at 200 mg once every two weeks.
Drug: HLX10
recombinant humanized anti-PD-1 monoclonal antibody against solid cancers
Other Name: anti-PD-1 monoclonal antibody




Primary Outcome Measures :
  1. Numbers and percentage of patients with adverse events (AEs) [ Time Frame: 1 year ]
  2. Maximum tolerated dose of HLX10 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) of HLX10 in different cohorts. [ Time Frame: 1 year ]
  2. Minimum concentration (Cmin) of HLX10 in different cohorts. [ Time Frame: 1 year ]
  3. Area under concentration (AUC0-tau) in different cohorts. [ Time Frame: 1 year ]
  4. Half-life (T1/2) of HLX10 in different cohorts. [ Time Frame: 1 year ]
  5. Clearance (CL) rate of HLX10 in different cohorts. [ Time Frame: 1 year ]
  6. Volume of distribution (Vss) at steady state in different cohorts. [ Time Frame: 1 year ]
  7. The presence and percentage of anti-HLX10 antibody (immunogenicity). [ Time Frame: 1 year ]
  8. Disease control rate. [ Time Frame: 1 year ]
  9. Overall response rate. [ Time Frame: 1 year ]
  10. Duration of response. [ Time Frame: 1 year ]
  11. Receptor occupancy of PD-1 on human T cells. [ Time Frame: 1 year ]
  12. Potential predictive and prognostic biomarkers. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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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 which no standard therapy is available.
  2. ECOG performance status score of ≤ 2 at study entry.
  3. Able to provide written informed consent.
  4. A life expectancy longer than three months as determined by the investigator.
  5. Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3; a hemoglobin level ≥ 10 gm/dL; a platelet count ≥ 100,000/mm3.
  6. 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 ≤ 2.5 x of ULN or ≤ 5x of ULN in known hepatic metastases or with primary hepatocellular carcinoma.
  7. Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute by Cockcroft-Gault formula.
  8. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50%.
  9. Use of effective contraceptive measures if procreative potential exists.
  10. At least 28 days from prior major surgery, prior cytotoxic chemotherapy, or prior therapy with investigational agents (or medical device) or local radiotherapy and at least 42 days from the last infusion of immune check point inhibitors (including anti-PD-1 or anti-PD-L1) before the first infusion of investigational product.
  11. For patients with hepatocellular carcinoma, their Child-Pugh score has to be A.
  12. Able to be followed up as required by the study protocol.

Exclusion Criteria:

  1. Patients who still have persistent ≥ grade 2 toxicities from prior therapies.
  2. 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.
  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 for brain edema). 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 ≥ 3 years are allowed to participate).
  5. Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or breast-feeding.
  6. Known history of human immunodeficiency virus infection (HIV).
  7. Patient who has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroid (more than 10 mg per day) or immunosuppressive agents.
  8. Patient who has active hepatitis B (HBsAg reactive) or hepatitis C (defined anti-HCV reactive)
  9. Patient who has a history of interstitial lung disease
  10. The patient is the investigator, sub-investigator or any one directly involved in the conduct of the study.
  11. 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.

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): NCT03468751


Contacts
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Contact: Eugene Liu, MD, PhD +886-2-27927927 ext 106 eliu@henlix.com
Contact: Shufan Lin, MS +886-2-27927927 slin@henlix.com

Locations
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Taiwan
Taipei Municipal Wanfang Hospital Recruiting
Taipei City, Taiwan, 11696
Contact: Principal Investigator         
Sponsors and Collaborators
Henlix, Inc
Investigators
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Principal Investigator: Gi-Ming Lai, MD Taipei Municipal Wanfang Hospital
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Responsible Party: Henlix, Inc
ClinicalTrials.gov Identifier: NCT03468751    
Other Study ID Numbers: HLX10-001
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henlix, Inc:
Metastatic; Refractory; Cancer; Solid; Tumor
Additional relevant MeSH terms:
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Neoplasms