Solid Tumor, AdultPhase 1NCT04169178
Evaluate Safety, Tolerability and PK of HLX55 in Patients With Advanced Solid Tumors With Different cMET Status
A Phase 1 study testing HLX55 in people with Solid Tumor, Adult, run by Henlix, Inc at 4 sites in Taiwan.
Trial summary
A mutilpe-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX55 in patients with advanced solid tumors overexpressing/Mutation/Amplification cMET after failure of standard of care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- HLX55
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 4 sitesTaiwan
- Study dates
- 3 Mar 2020to Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must be 18-years of age or older (or per local regulations) and ≦75 years of age.
- For dose finding stage: patients with measurable or evaluable advanced or metastatic solid tumours who have failed standard therapy or for whom no standard therapy is available.
- For dose expansion stage: patients with measurable or evaluable advanced or metastatic solid tumors with histologically confirmed c-MET mutations (MET exon 14 mutations) or amplifications (MET/CEP7 ratio ≥ 2.0 or MET ≥ 5.0 copies) or over-expression (immunohistochemistry [IHC] score ≥ 2+) and have failed standard therapy or for whom no standard therapy is available. Positive c-MET mutation/amplification/over-expression results should be available before the subject can receive HLX55.
- No prior therapy with MET-targeting biological agents (patients who have received prior therapy with a MET-targeting tyrosine kinase inhibitor [TKI] is allowed.)
- Must be able to supply adequate tumor tissue. (Adequate tumor biopsy material means (1) newly biopsied or archival tissue biopsied within 60 days before the first dosing, (2) Biopsy materials should be adequate for biomarker analysis (c-MET/Kras/EGFR).
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study entry.
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- Able to provide informed consent.
- A life expectancy longer than three months.
- Adequate hematologic functions, as defined by absolute neutrophil counts ≥ 1500/mm3; a haemoglobin level ≥ 9 gm/dL; a platelet count ≥ 100,000/mm3 and an international normalized ratio ≤ 1.5.
- An adequate hepatic function defined by a total bilirubin level ≤ 1.5 x of upper limit of normal values (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x of ULN or ≤ 5 x 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. In patients with extreme body weights (body mass index [BMI] < 18.5 OR > 30) estimated glomerular filtration rate (eGFR) ≥ 50ml/min calculated by Modification of Diet in Renal Disease (MDRD) formula is acceptable.
- Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% measured by either cardiac echo or multigated acquisition (MUGA) scan.
- At least 21days from prior cytotoxic chemotherapy, prior therapy with investigational small molecule agents (or medical device) or radiotherapy, at least 28 days from prior immunotherapy, biological agents or prior major surgery and at least 14 days from prior hormonal therapy and minor surgery before infusion of first dose of HLX55.
- For patients with hepatocellular carcinoma, their Child-Pugh score must be A.
- Able to be followed up as required by the study protocol.
- Female participants must have a negative pregnancy test at screening if of childbearing potential or be of non-childbearing potential.
- Female participants of childbearing potential and male partners with female partners of childbearing potential must agree to use 2 adequate barrier methods of contraception during the study and for at least 180 days after last dose of study drug.
Who cannot join
- Patients who still have ≥ grade 2 toxicities from prior therapies.
- Concurrent unstable or uncontrolled medical conditions with either of the followings:
- Active systemic infections requiring intravenous antibiotic use within 1 week;
- Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
- Clinically significant arrhythmia requiring anti-arrhythmia therapy, 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 defined by glycated hemoglobin (HbA1c) ≥ 9.5%;
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- The presence of chronically unhealed wound or ulcers;
- Uncontrolled hypercalcemia (defined as persistent Ionized (free) Calcium ≥ 6.5 mg/dl despite appropriate management.)
- Other chronic diseases, which, in the opinion of the investigator, could compromise the safety of the patient or the integrity of 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 for brain edema at least 14 days before infusion of the first dose of HLX55 can be allowed in the study). 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 can participate).
- Known history of human immunodeficiency virus infection (HIV), hepatitis B virus carrier status (HBV surface antigen positive) and hepatitis C carrier (anti-HCV antibody positive).
- The patient is the investigator, sub-investigator or anyone directly involved in the conduct of the study.
- History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator(s), is not in the best interest of the patient to participate.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites, 4 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Wu-Chou Su, 886-6-2353535 ext. 4292
- Recruiting
Tri-Service General Hospital
Taipei, 114
Ching-Liang Ho, 886-2-8792-7211
- Recruiting
Taipei Minicipal Wangfang Hospital
Taipei, 116
Chia Lun Chang, 886-2-2930-7930 ext. 2545
- Recruiting
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Taipei County, 235
Tsu-Yi Chao, 886-2-22490088 ext. 8878
About this study
Official title: A Phase 1 Dose Finding/Expansion Study of HLX55, A Monoclonal Antibody Targeting Tyrosine-Protein Kinase MET (C-MET) in Patients With Advanced Solide Tumors Refactory to Standard Therapy
A mutilpe-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX55 in patients with advanced solid tumors overexpressing/Mutation/Amplification cMET after failure of standard of care.
Read the detailed description
This study is an open-label and dose escalation study including dose finding stage and expansion stage.
In dosing finding stage, the study will precede in two phases, (i) a modified accelerated titration design 2A (ATD 2A) phase and (ii) a traditional 3+3 dose escalation phase aimed at exploring the safety and MTD of HLX55. Four dose levels are designed for HLX55 in this stage: 2.5, 5, 15, and 25 mg/kg/3 weeks. The 5 mg/kg/3 weeks will serve as the starting dose.
In the dose-expansion stage, three to five cohorts are planned, and different cohorts will evaluate the efficacy of HLX55 for potential indications. Maximum 20 patients will be accrued in each cohort.
- Conditions
- Solid Tumor, Adult
- Being tested
- HLX55
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX55Drug
Also called HLX55 monoclonal antibody for Injection
A humanized IgG2 monoclonal antibody targeting tyrosine-protein kinase MET (c-MET)
| Study group | Role | What they receive |
|---|---|---|
| HLX55, dose finding stage, advanced solid tumor | Experimental | Participants will receive HLX55 at assign dose level, e.g. 2.5, 5, 15 and 25 mg/kg every three weeks followed by a 21-day DLT observation period. Receives: Drug: HLX55 |
| HLX55, dose expansion stage, gastric cancer | Experimental | Participants diagnosed with gastric cancer with will receive HLX55 in recommended phase 2 dose (RP2D) every three weeks. Receives: Drug: HLX55 |
| HLX55, dose expansion stage, NSCLC | Experimental | Participants diagnosed with non-small cell lung cancer (NSCLC) with will receive HLX55 in RP2D every three weeks. Receives: Drug: HLX55 |
| HLX55, dose expansion stage, colorectal cancer | Experimental | Participants diagnosed with colorectal cancer (CRC) with will receive HLX55 in RP2D every three weeks. Receives: Drug: HLX55 |
| HLX55, dose expansion stage, other solid cancer | Experimental | Participants diagnosed with other solid cancer with will receive HLX55 in RP2D every three weeks. Receives: Drug: HLX55 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose finding stage-safety
Numbers and percentage of patients with adverse events (AEs).
Measured: Up to 2 years
Dose finding stage-MTD or RP2D
The maximum tolerated dose and recommended phase 2 dose (RP2D) of HLX55.
Measured: Up to 2 years
Dose expansion stage-safety
Numbers and percentage of patients with adverse events (AEs).
Measured: Up to 2 years
Dose expansion stage-efficacy
Disease control rate (DCR).
Measured: Up to 2 years
Dose expansion stage-efficacy
Overall response rate (ORR).
Measured: Up to 2 years
Dose expansion stage-efficacy
Duration of response (DOR).
Measured: Up to 2 years
Secondary outcomes (3)
Dose finding stage and dose expansion stage-PK profile
PK profile of HLX55 including maximum concentration (Cmax), minimum concentration (Cmin), area under concentration (AUC0-tau), half-life (T1/2), clearance (CL) rate and the volume of distribution at steady state (Vss) at different doses.
Measured: Through study completion, up to 2 years.
Dose finding stage and dose expansion stage-serum HGF levels
Changes in serum HGF levels before and at different time-points after HLX55 treatment.
Measured: Cycle 1 to 3 (each cycle is 21 days)
Dose finding stage and dose expansion stage-immunogenicity
The presence and percentage of anti-HLX55 antibody-positive patients (immunogenicity) by measurement of anti-HLX55 antibodies in serum.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start3 Mar 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henlix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsu-Yi Chao, MD. PhD., Principal investigator, Shuang Ho Hospital,Ministry of Health and Welfare, Taipei, TaiwanChing-Liang Ho, MD, Principal investigator, Tri-Service General Hospital, Taipei, TaiwanWu-Chou Su, MD. PhD., Principal investigator, National Cheng Kung University Hospital, Tainan, TaiwanChia-Lun Chang, MD, Principal investigator, Taipei Municipal Wanfang Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169178
- Sponsor's protocol ID
- HLX55-001
- Status last verified
- Apr 2020
- First submitted
- 13 Nov 2019
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Finding/Expansion Study of HLX55, A Monoclonal Antibody Targeting Tyrosine-Protein Kinase MET (C-MET) in Patients With Advanced Solide Tumors Refactory to Standard Therapy
- ClinicalTrials.gov ID
- NCT04169178
- Acronym / sponsor ID
- HLX55-001
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Henlix, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Nov 2019 (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.
A mutilpe-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX55 in patients with advanced solid tumors overexpressing/Mutation/Amplification cMET after failure of standard of care.
Detailed description
This study is an open-label and dose escalation study including dose finding stage and expansion stage.
In dosing finding stage, the study will precede in two phases, (i) a modified accelerated titration design 2A (ATD 2A) phase and (ii) a traditional 3+3 dose escalation phase aimed at exploring the safety and MTD of HLX55. Four dose levels are designed for HLX55 in this stage: 2.5, 5, 15, and 25 mg/kg/3 weeks. The 5 mg/kg/3 weeks will serve as the starting dose.
In the dose-expansion stage, three to five cohorts are planned, and different cohorts will evaluate the efficacy of HLX55 for potential indications. Maximum 20 patients will be accrued in each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HLX55, dose finding stage, advanced solid tumor | Experimental | Drug: HLX55Participants will receive HLX55 at assign dose level, e.g. 2.5, 5, 15 and 25 mg/kg every three weeks followed by a 21-day DLT observation period. |
| HLX55, dose expansion stage, gastric cancer | Experimental | Drug: HLX55Participants diagnosed with gastric cancer with will receive HLX55 in recommended phase 2 dose (RP2D) every three weeks. |
| HLX55, dose expansion stage, NSCLC | Experimental | Drug: HLX55Participants diagnosed with non-small cell lung cancer (NSCLC) with will receive HLX55 in RP2D every three weeks. |
| HLX55, dose expansion stage, colorectal cancer | Experimental | Drug: HLX55Participants diagnosed with colorectal cancer (CRC) with will receive HLX55 in RP2D every three weeks. |
| HLX55, dose expansion stage, other solid cancer | Experimental | Drug: HLX55Participants diagnosed with other solid cancer with will receive HLX55 in RP2D every three weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Eligible patients must be 18-years of age or older (or per local regulations) and ≦75 years of age.
- For dose finding stage: patients with measurable or evaluable advanced or metastatic solid tumours who have failed standard therapy or for whom no standard therapy is available.
- For dose expansion stage: patients with measurable or evaluable advanced or metastatic solid tumors with histologically confirmed c-MET mutations (MET exon 14 mutations) or amplifications (MET/CEP7 ratio ≥ 2.0 or MET ≥ 5.0 copies) or over-expression (immunohistochemistry [IHC] score ≥ 2+) and have failed standard therapy or for whom no standard therapy is available. Positive c-MET mutation/amplification/over-expression results should be available before the subject can receive HLX55.
- No prior therapy with MET-targeting biological agents (patients who have received prior therapy with a MET-targeting tyrosine kinase inhibitor [TKI] is allowed.)
- Must be able to supply adequate tumor tissue. (Adequate tumor biopsy material means (1) newly biopsied or archival tissue biopsied within 60 days before the first dosing, (2) Biopsy materials should be adequate for biomarker analysis (c-MET/Kras/EGFR).
Key exclusion criteria (14 listed)
- Patients who still have ≥ grade 2 toxicities from prior therapies.
- Concurrent unstable or uncontrolled medical conditions with 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 at least 14 days before infusion of the first dose of HLX55 can be allowed in the study). 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 can participate).
- Known history of human immunodeficiency virus infection (HIV), hepatitis B virus carrier status (HBV surface antigen positive) and hepatitis C carrier (anti-HCV antibody positive).
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 |
|---|---|---|
| HLX55Also: HLX55 monoclonal antibody for InjectionA humanized IgG2 monoclonal antibody targeting tyrosine-protein kinase MET (c-MET) | Drug | HLX55, dose expansion stage, NSCLC, HLX55, dose expansion stage, colorectal cancer, HLX55, dose expansion stage, gastric cancer, HLX55, dose expansion stage, other solid cancer, HLX55, dose finding stage, advanced solid tumor |
Primary outcome
Dose finding stage-safety
Time frame: Up to 2 years
Numbers and percentage of patients with adverse events (AEs).
Dose finding stage-MTD or RP2D
Time frame: Up to 2 years
The maximum tolerated dose and recommended phase 2 dose (RP2D) of HLX55.
Dose expansion stage-safety
Time frame: Up to 2 years
Numbers and percentage of patients with adverse events (AEs).
Dose expansion stage-efficacy
Time frame: Up to 2 years
Disease control rate (DCR).
Dose expansion stage-efficacy
Time frame: Up to 2 years
Overall response rate (ORR).
Dose expansion stage-efficacy
Time frame: Up to 2 years
Duration of response (DOR).
3 secondary outcomes
Dose finding stage and dose expansion stage-PK profile
Time frame: Through study completion, up to 2 years.
Dose finding stage and dose expansion stage-serum HGF levels
Time frame: Cycle 1 to 3 (each cycle is 21 days)
Dose finding stage and dose expansion stage-immunogenicity
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- 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.
Tsu-Yi Chao, MD. PhD. principal investigator
Shuang Ho Hospital,Ministry of Health and Welfare, Taipei, Taiwan
Ching-Liang Ho, MD principal investigator
Tri-Service General Hospital, Taipei, Taiwan
Wu-Chou Su, MD. PhD. principal investigator
National Cheng Kung University Hospital, Tainan, Taiwan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX55 in people with Solid Tumor, Adult, run by Henlix, Inc at 4 sites 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 17 inclusion and 14 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 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 PeiZhi Lu (+886-2-792-7927 ext. 107, plu@henlix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose finding stage-safety (time frame: Up to 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.