Solid TumorPhase 1NCT03468751
Phase 1 Study of HLX10, a Monoclonal Antibody Targeting Programmed Death-1 (PD-1) in Patients With Advanced Solid Tumors
A Phase 1 study testing HLX10 in people with Solid Tumor, run by Henlix, Inc at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HLX10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Feb 2018to 31 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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
- The patient is the investigator, sub-investigator or any one directly involved in the conduct of the study.
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Municipal Wanfang Hospital
Taipei, 11696
Principal Investigator
About this study
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
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.
Read the detailed description
The lack of immunologic control is currently recognized as one of the hallmarks of cancer. The cancer immunoediting concept has been proposed as a mechanism by which tumors escape control. The concept involves three phases: elimination (tumor cell eradication), equilibrium (when editing of surviving tumor cells occurs) and escape (when the altered tumor cells progress through the shield of the activated immune response).
When the TCR of a T cell recognizes antigens expressed in the context of the MHC, the immune checkpoint modulates signaling: co-stimulatory molecules such as CD28 on T cells enhance the signal, whereas co-inhibitory molecules suppress it. Recent research has implicated the expression of immunoinhibitory checkpoints such as CTL antigen 4 (CTLA-4) and programmed death protein 1 (PD-1) as potential mediators of the equilibrium and escape phases of cancer immunoediting described above. These molecules are expressed on activated T cells, but when they bind to ligands either on antigen-presenting cells (CTLA-4 binding to CD80/CD86) or tumor cells (PD-1 binding to PD-L1), they tend to shut down the anti-tumor response. Efforts to use antibodies to target and block these immuno-inhibitory interactions have ushered in a new era of immunotherapy.
Tumors display a wide variety of antigens that can potentially be exploited by harnessing the adaptive immune response. The T-cell response to these antigens can be dysregulated by tumor cells seeking to evade immunologic detection and destruction by hijacking physiological homeostatic immune-checkpoint signaling pathways. In addition to a variety of mechanisms that can create an immunosuppressive microenvironment (e.g. secretion of inhibitory cytokines, presence of regulatory T cells), many tumor types also express PD-L1.
Nivolumab and pembrolizumab are the two anti-PD1 monoclonal antibodies currently approved for multiple cancers. The application of nivolumab or pembrolizumab alone or in combination with chemotherapy has completely changed cancer management.
HLX10 is a new monoclonal antibody targeting PD1 on T cells, developed from mouse hybridoma technology. In vitro studies have demonstrated the growth inhibition of multiple cancer cell lines, and shown growth inhibition of tumors in murine xenogeneic studies.
Nonclinical studies dosing up to 50 mg/kg HLX10 weekly in cynomolgus monkeys for 13 weeks have shown good tolerability without evident toxicities (please refer to Investigator's Brochure). HLX10 shows cross-reactivity to both monkey and human PD1, but does not bind rodent PD1.
Based on the pharmacology studies and pharmacokinetic and toxicokinetic studies in cynomolgus monkeys, this study is a phase-1 study to address the safety and tolerability of HLX10 in patients with metastatic or recurrent cancer.
HLX10 has not yet been tested in human. Therefore, the investigators propose this first-in-human phase 1 study. In this study, the investigators intend to investigate the safety, and tolerability of HLX10 in humans, and hope to identify the maximum tolerated dose (MTD), and determine the recommended phase 2 dose in future study. At the same time, the investigators would like to gain information of the pharmacokinetics and pharmacodynamics of this drug and its potential immunogenicity.
To minimize the risk of patients who volunteer to receive this experimental drug, the investigators will choose 0.1 mg/kg as the initial starting dose. The selection of starting dose is based on the repeat-dose toxicology study on monkey, at 1/166 of the human equivalent dose of No-Observed Adverse Effect Level (NOAEL) in cynomolgus studies.
To investigate the dose required to reach maximal effect, the investigators propose a dose escalation sequence. The purpose of the dose escalation is to obtain the pharmacokinetics and pharmacodynamics of HLX10 at different dose levels, and investigate its relationship with adverse reactions. The investigators also intend to identify the MTD. The information from the dose escalation is crucial to determine the optimal dose in future studies and potential indications for HLX10.
- Conditions
- Solid Tumor
- Being tested
- HLX10
- Keywords
- Metastatic; Refractory; Cancer; Solid; Tumor
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX10Drug
Also called anti-PD-1 monoclonal antibody
recombinant humanized anti-PD-1 monoclonal antibody against solid cancers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: HLX10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers and percentage of patients with adverse events (AEs)
Measured: 1 year
Maximum tolerated dose of HLX10
Measured: 1 year
Secondary outcomes (12)
Maximum concentration (Cmax) of HLX10 in different cohorts.
Measured: 1 year
Minimum concentration (Cmin) of HLX10 in different cohorts.
Measured: 1 year
Area under concentration (AUC0-tau) in different cohorts.
Measured: 1 year
Half-life (T1/2) of HLX10 in different cohorts.
Measured: 1 year
Clearance (CL) rate of HLX10 in different cohorts.
Measured: 1 year
Volume of distribution (Vss) at steady state in different cohorts.
Measured: 1 year
The presence and percentage of anti-HLX10 antibody (immunogenicity).
Measured: 1 year
Disease control rate.
Measured: 1 year
Overall response rate.
Measured: 1 year
Duration of response.
Measured: 1 year
Receptor occupancy of PD-1 on human T cells.
Measured: 1 year
Potential predictive and prognostic biomarkers.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start14 Feb 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henlix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gi-Ming Lai, MD, Principal investigator, Taipei Municipal Wanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468751
- Sponsor's protocol ID
- HLX10-001
- Status last verified
- May 2019
- First submitted
- 11 Mar 2018
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38194016
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03468751
- Acronym / sponsor ID
- HLX10-001
- Conditions
- Solid Tumor
- Keywords
- Metastatic; Refractory; Cancer; Solid; Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henlix, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The lack of immunologic control is currently recognized as one of the hallmarks of cancer. The cancer immunoediting concept has been proposed as a mechanism by which tumors escape control. The concept involves three phases: elimination (tumor cell eradication), equilibrium (when editing of surviving tumor cells occurs) and escape (when the altered tumor cells progress through the shield of the activated immune response).
When the TCR of a T cell recognizes antigens expressed in the context of the MHC, the immune checkpoint modulates signaling: co-stimulatory molecules such as CD28 on T cells enhance the signal, whereas co-inhibitory molecules suppress it. Recent research has implicated the expression of immunoinhibitory checkpoints such as CTL antigen 4 (CTLA-4) and programmed death protein 1 (PD-1) as potential mediators of the equilibrium and escape phases of cancer immunoediting described above. These molecules are expressed on activated T cells, but when they bind to ligands either on antigen-presenting cells (CTLA-4 binding to CD80/CD86) or tumor cells (PD-1 binding to PD-L1), they tend to shut down the anti-tumor response. Efforts to use antibodies to target and block these immuno-inhibitory interactions have ushered in a new era of immunotherapy.
Tumors display a wide variety of antigens that can potentially be exploited by harnessing the adaptive immune response. The T-cell response to these antigens can be dysregulated by tumor cells seeking to evade immunologic detection and destruction by hijacking physiological homeostatic immune-checkpoint signaling pathways. In addition to a variety of mechanisms that can create an immunosuppressive microenvironment (e.g. secretion of inhibitory cytokines, presence of regulatory T cells), many tumor types also express PD-L1.
Nivolumab and pembrolizumab are the two anti-PD1 monoclonal antibodies currently approved for multiple cancers. The application of nivolumab or pembrolizumab alone or in combination with chemotherapy has completely changed cancer management.
HLX10 is a new monoclonal antibody targeting PD1 on T cells, developed from mouse hybridoma technology. In vitro studies have demonstrated the growth inhibition of multiple cancer cell lines, and shown growth inhibition of tumors in murine xenogeneic studies.
Nonclinical studies dosing up to 50 mg/kg HLX10 weekly in cynomolgus monkeys for 13 weeks have shown good tolerability without evident toxicities (please refer to Investigator's Brochure). HLX10 shows cross-reactivity to both monkey and human PD1, but does not bind rodent PD1.
Based on the pharmacology studies and pharmacokinetic and toxicokinetic studies in cynomolgus monkeys, this study is a phase-1 study to address the safety and tolerability of HLX10 in patients with metastatic or recurrent cancer.
HLX10 has not yet been tested in human. Therefore, the investigators propose this first-in-human phase 1 study. In this study, the investigators intend to investigate the safety, and tolerability of HLX10 in humans, and hope to identify the maximum tolerated dose (MTD), and determine the recommended phase 2 dose in future study. At the same time, the investigators would like to gain information of the pharmacokinetics and pharmacodynamics of this drug and its potential immunogenicity.
To minimize the risk of patients who volunteer to receive this experimental drug, the investigators will choose 0.1 mg/kg as the initial starting dose. The selection of starting dose is based on the repeat-dose toxicology study on monkey, at 1/166 of the human equivalent dose of No-Observed Adverse Effect Level (NOAEL) in cynomolgus studies.
To investigate the dose required to reach maximal effect, the investigators propose a dose escalation sequence. The purpose of the dose escalation is to obtain the pharmacokinetics and pharmacodynamics of HLX10 at different dose levels, and investigate its relationship with adverse reactions. The investigators also intend to identify the MTD. The information from the dose escalation is crucial to determine the optimal dose in future studies and potential indications for HLX10.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX10, Dose Finding Cohort | Experimental | Drug: HLX10Each 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. |
| HLX10, Dose Expansion Cohort (200 mg ) | Experimental | Drug: HLX10Each 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- Patients who still have persistent ≥ grade 2 toxicities from prior therapies.
- Concurrent unstable or uncontrolled medical conditions. Either of the followings:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX10Also: anti-PD-1 monoclonal antibodyrecombinant humanized anti-PD-1 monoclonal antibody against solid cancers | Drug | HLX10, Dose Expansion Cohort (200 mg ), HLX10, Dose Finding Cohort |
Primary outcome
Numbers and percentage of patients with adverse events (AEs)
Time frame: 1 year
Maximum tolerated dose of HLX10
Time frame: 1 year
12 secondary outcomes
Maximum concentration (Cmax) of HLX10 in different cohorts.
Time frame: 1 year
Minimum concentration (Cmin) of HLX10 in different cohorts.
Time frame: 1 year
Area under concentration (AUC0-tau) in different cohorts.
Time frame: 1 year
Half-life (T1/2) of HLX10 in different cohorts.
Time frame: 1 year
Clearance (CL) rate of HLX10 in different cohorts.
Time frame: 1 year
Volume of distribution (Vss) at steady state in different cohorts.
Time frame: 1 year
The presence and percentage of anti-HLX10 antibody (immunogenicity).
Time frame: 1 year
Disease control rate.
Time frame: 1 year
Overall response rate.
Time frame: 1 year
Duration of response.
Time frame: 1 year
Receptor occupancy of PD-1 on human T cells.
Time frame: 1 year
Potential predictive and prognostic biomarkers.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 38194016Ho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gi-Ming Lai, MD principal investigator
Taipei Municipal Wanfang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX10 in people with Solid Tumor, run by Henlix, Inc at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugene Liu, MD, PhD (+886-2-27927927 ext. 106, eliu@henlix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers and percentage of patients with adverse events (AEs) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.