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

NCT03468751 | Unknown Phase 1 FDA Drug

• 1 other identifier: HLX10-001
• Study Type: interventional
• Target: 30
• 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 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.

Conditions

Solid Tumor

Keywords

Metastatic; Refractory; Cancer; Solid; Tumor

Outcome Measures

Primary Outcomes (2)

• Numbers and percentage of patients with adverse events (AEs)

  1 year

• Maximum tolerated dose of HLX10

  1 year

Secondary Outcomes (12)

• Maximum concentration (Cmax) of HLX10 in different cohorts.

  1 year

• Minimum concentration (Cmin) of HLX10 in different cohorts.

  1 year

• Area under concentration (AUC0-tau) in different cohorts.

  1 year

• Half-life (T1/2) of HLX10 in different cohorts.

  1 year

• Clearance (CL) rate of HLX10 in different cohorts.

  1 year

Study Arms (2)

HLX10, Dose Finding Cohort

EXPERIMENTAL

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

HLX10, Dose Expansion Cohort (200 mg )

EXPERIMENTAL

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

Interventions

HLX10 DRUG

recombinant humanized anti-PD-1 monoclonal antibody against solid cancers

Also known as: anti-PD-1 monoclonal antibody

HLX10, Dose Expansion Cohort (200 mg ); HLX10, Dose Finding Cohort

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 which no standard therapy is available.
• ECOG performance status score of ≤ 2 at study entry.
• Able to provide written informed consent.
• A life expectancy longer than three months as determined by the investigator.
• 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 ≤ 2.5 x 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 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.
• 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 who still have persistent ≥ grade 2 toxicities from prior therapies.
• 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.
• 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.
• Known history of human immunodeficiency virus infection (HIV).
• 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.
• Patient who has active hepatitis B (HBsAg reactive) or hepatitis C (defined anti-HCV reactive)
• Patient who has a history of interstitial lung disease

Sponsors & Collaborators

• Henlix, Inc: lead

Study Sites (1)

Taipei Municipal Wanfang Hospital

Taipei, 11696, Taiwan

RECRUITING

Related Publications (1)

• Ho CL, Chao TY, Chang CL, Lin HY. Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study. BioDrugs. 2024 Mar;38(2):287-299. doi: 10.1007/s40259-023-00639-w. Epub 2024 Jan 9.

  PMID: 38194016 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Gi-Ming Lai, MD

  Taipei Municipal Wanfang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene Liu, MD, PhD

CONTACT

+886-2-27927927; eliu@henlix.com

Shufan Lin, MS

CONTACT

+886-2-27927927; slin@henlix.com

Study Design

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

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 19, 2018
• Study Start: February 14, 2018
• Primary Completion: June 30, 2020
• Study Completion: August 31, 2020
• Last Updated: June 1, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)