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Advanced Solid TumorsPhase 1/2HLX07Ib/IINCT03577704

The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors.

A Phase 1/2 study testing HLX07+Gemcitabine+Cisplatin, HLX07+Paclitaxel+Carboplatin and HLX07+mFOLFOX6 in people with Advanced Solid Tumors, run by Shanghai Henlius Biotech at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

HLX07 is a new anti-EGFR monoclonal antibody (mAb) with improved glycosylation pattern.In pre-clinical efficacy studies, HLX-07 is either equivalent or more potent than cetuximab in multiple cancer models without increased toxicities.This study is an open-labeled, dose-escalation study designed to explore the maximum… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HLX07+Gemcitabine+Cisplatin, HLX07+Paclitaxel+Carboplatin and HLX07+mFOLFOX6
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
8 Aug 2018to 30 Dec 2022
Phase
Phase 1/2
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

  • Patients with histologically confirmed metastatic or recurrent advanced solid tumors which has indication to receive treatment with one of above three chemotherapy regimens.The lesions must be assessable based on the RECIST v1.1 criteria.The number of previously received chemotherapy regimens should not exceed two.
  • At least 28 days from prior major surgery, prior cytotoxic chemotherapy, or prior therapy with investigational agents or local radiotherapy and at least 42 days from the last infusion of immune check point inhibitors (The antibodies or drugs include but not limited to IDO, PD-1, PD-L1, IL-2R, CTLA-4, CD137, and GITR) before the first infusion of investigational product.
  • Eastern Cooperative Oncology Group (ECOG) score ≤ 1,
  • Expected survival time ≥ 3 months;
  • Has sufficient hematological function, defined as: neutrophil absolute value ≥ 1.5 × 109 / L; hemoglobin level ≥ 9.0 g / dL ; Platelet count ≥100×109 /L.
  • Has sufficient liver function, defined as: total bilirubin level ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN, For patients with known liver metastases or primary hepatocellular carcinoma patients ≤ 5 x ULN.
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  • Has adequate coagulation function defined as: International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 x ULN, and activated partial thromboplastin time (PTT) in the absence of anticoagulant therapy /aPTT) ≤ 1.5 x ULN.
  • Has adequate cardiac function, defined as: left ventricular ejection fraction (LVEF) ≥ 50%.
  • Has sufficient renal function; in patients receiving the gemcitabine plus cisplatin regimen is defined as creatinine clearance ≥ 60 ml/min and in patients receiving the paclitaxel plus carboplatin regimen or the mFOLFOX6 regimen, is defined as creatinine clearance ≥ 50 ml/min (calculated by the Cockcroft-Gault formula).
  • Use of effective contraceptive measures if procreative potential exists.
  • Able to provide written informed consent.

Who cannot join

  • 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;
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  • Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
  • Unstable central nervous system (CNS) metastasis. Patients who have previously undergone surgery or radiotherapy for brain metastases may participate in this study if they are clinically stable for at least 4 weeks and has stopped steroids for at least 2 weeks prior to the first infusion of the test drug and there is no new evidence of progression.
  • Has primary central nervous system malignancy;
  • Known patients have drug allergies to specific drug regimens (eg anti-EGFR monoclonal antibodies, gemcitabine, platinum, paclitaxel, fluorouracil allergy);
  • known active hepatitis B or C infection (active hepatitis B is defined as hepatitis B surface antigen HBsAg positive and Hepatitis B virus (HBV) DNA> 500 copies / ml; active hepatitis C is defined as hepatitis C antibody-positive and / or quantitative Hepatitis C virus (HCV) RNA results positive);
  • Human immunodeficiency virus infection .
  • Pregnancy or breast-feeding woman.
  • Patients with colorectal cancer whose tumors have K-ras, N-ras, or B-raf mutations;
  • The patient has a history of alcohol abuse or drug abuse;
  • Use of herbal medicine within the first 2 weeks before the first infusion of the test drug;
  • Treatment with systemic steroids (equivalent to >10 mg/day of methylprednisolone) or any other form of immunosuppressive therapy within 2 weeks of the first infusion of the test drug;
  • 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.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Official title: An Exploratory Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody) Combined With Chemotherapy in Patients With Advanced Solid Tumors.

HLX07 is a new anti-EGFR monoclonal antibody (mAb) with improved glycosylation pattern.In pre-clinical efficacy studies, HLX-07 is either equivalent or more potent than cetuximab in multiple cancer models without increased toxicities.This study is an open-labeled, dose-escalation study designed to explore the maximum tolerated dose (MTD) and safety of HLX07 in combination with different chemotherapy regimens.

Read the detailed description

This study is a parallel 3-arm escalation trial with 3 doses of HLX07 (400 mg, 600 mg, or 800 mg per single dose) combined with 3 different fixed-dose chemotherapy regimens.

Three chemotherapy regimens are：

① Gemcitabine (1000 mg/m2) and Cisplatin (75 mg/m2) , every three weeks. Gemcitabine was administered on the first day and on the 8th day, and cisplatin 75 mg/m2 was administered on the first day , a total of 4-6 cycles。

② Paclitaxel (80 mg/m2) and carboplatin (AUC=2), every 3 weeks. Paclitaxel and carboplatin were administered on days 1, 8 and 15 for a total of 4-6 cycles.

③ mFOLFOX6 protocol: oxaliplatin (85 mg/m2), leucovorin (400 mg/m2), and 5-fluouracil (5-FU) (400 mg/m2, followed by 2400 mg/m2), every 2 weeks. Oxaliplatin, leucovorin and 5-FU were administered on the first day.

After 4 to 6 cycles of (gemcitabine and cisplatin regimens) and (the paclitaxel and carboplatin regimens) or after 6 to 12 cycles of the mFOLFOX6 regimen, well-controlled patients will be continue to receive a weekly HLX07 infusion as maintenance therapy for maximum 2 years or until disease progression or emergence of intolerable toxicity or permanent withdrawal or death (whichever comes first).

The study used the Bayes optimal interval design (BOIN) to determine the MTD of HLX07 in combination with chemotherapy.

Being tested
HLX07+Gemcitabine+Cisplatin, HLX07+Paclitaxel+Carboplatin, HLX07+mFOLFOX6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX07+Gemcitabine+CisplatinDrug

    Also called Recombinant anti-EGFR humanized monoclonal antibody, Gemzar, Cisplatin

    Recombinant anti-EGFR humanized monoclonal antibody in combination with Gemcitabine and Cisplatin.

    HLX07, IV, weekly.

  • HLX07+Paclitaxel+CarboplatinDrug

    Also called Recombinant anti-EGFR humanized monoclonal antibody, Paclitaxel, Carboplatin

    Recombinant anti-EGFR humanized monoclonal antibody in combination with Paclitaxel and Carboplatin.

    HLX07, IV, weekly.

  • HLX07+mFOLFOX6Drug

    Also called Recombinant anti-EGFR humanized monoclonal antibody, Oxaliplatin for Injection, Folinic acid calcium salt hydrate, 5-fluouracil

    Recombinant anti-EGFR humanized monoclonal antibody in combination with Oxaliplatin, Calcium Folinate and 5-FU.

    HLX07, IV, weekly.

Study groups in NCT03577704
Study groupRoleWhat they receive
HLX07+Gemcitabine+Cisplatin armExperimentalHLX07 is given on D1,D8,D15 combine with Gemcitabine (1000 mg/m2) and Cisplatin (75 mg/m2) in 3 weeks- cycles for 4-6 cycles .Gemcitabine was administered on the D1 and D8 and cisplatin 75 mg/m2 was administered on the D1. After 4-6 cycles of combination therapy, once weekly HLX07 infusion will be continue for a maximum duration of 2 years or until disease progression or emergence of intolerable toxicity or permanent withdrawal or death (whichever comes first). In each cohort, HLX07 will use BOIN design to assign the subject's dose level and determine the MTD.
Receives: Drug: HLX07+Gemcitabine+Cisplatin
HLX07+Paclitaxel+Carboplatin armExperimentalHLX07 is given on D1,D8,D15 combine with Paclitaxel (80 mg/m2) and carboplatin (AUC=2) in 3 weeks-cycle for 4-6 cycles .Paclitaxel and carboplatin were administered on D1, D8 and D15. After 4-6 cycles of combination therapy, once weekly HLX07 infusion will be continue for a maximum duration of 2 years or until disease progression or emergence of intolerable toxicity or permanent withdrawal or death (whichever comes first). In each cohort, HLX07 will use BOIN design to assign the subject's dose level and determine the MTD.
Receives: Drug: HLX07+Paclitaxel+Carboplatin
HLX07+mFOLFOX6 armExperimentalHLX07 is given on D1,D8 combine with mFOLFOX6 ( oxaliplatin (85 mg/m2), leucovorin (400 mg/m2), and 5-FU (400 mg/m2, followed by 2400 mg/m2) in 2 weeks-cycles for 6-12 cycles . Oxaliplatin, leucovorin and 5-FU were administered on D1. After 6-12 cycles of combination therapy,once weekly HLX07 infusion will be continue for a maximum duration of 2 years or until disease progression or emergence of intolerable toxicity or permanent withdrawal or death (whichever comes first). In each cohort, HLX07 will use BOIN design to assign the subject's dose level and determine the MTD.
Receives: Drug: HLX07+mFOLFOX6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum tolerated dose of HLX07 combined with different chemotherapy regimen

    The incidence of DLT combined with different chemotherapy regimens based on NCI CTCAE v4.03

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2018
  2. Study start8 Aug 2018
  3. Primary completion30 Sep 2022
  4. Study completion30 Dec 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The study used the Bayes optimal interval design (BOIN) to assign the subject's dose level and determine the maximum tolerated dose (MTD) of HLX07 in combination with chemotherapy.Each cohort contains 3 subjects and the patient in the first cohort receives treatment at the lowest dose level (single dose of 400 mg). The decision to increase or decrease the dose after each train is based on the probability of a predefined safety and toxicity threshold. When the observed rate of dose limiting toxicity (DLT) is less than 0.237 (low target safety margin), the dose for the next cohort escalates; when the observed rate of DLT is higher than 0.359 (target high toxicity cutoff), the dose deescalates. Otherwise, the dose remains the same. After each cohort is finished, a safety review committee will be held to determine the escalates or deescalates in the next cohort. The enrollment continues until the maximum 30 patients are reached.
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03577704
Sponsor's protocol ID
HLX07-002
Acronym
HLX07Ib/II
Status last verified
Apr 2023
First submitted
11 Jun 2018
Last updated
12 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • M.M. Hou, C.L. Ho, H.Y. Lin, W. Jiang, S. Liu, Y. Hong, A. Luk, S.F. Lin, T.C. Hsieh, E. Liu. A novel anti-EGFR antibody HLX07 for potential treatment of squamous cell carcinoma of the head and neck. Annals of Oncology. Volume 30 | Supplement 9 | November 2019.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HLX07+Gemcitabine+Cisplatin, HLX07+Paclitaxel+Carboplatin and HLX07+mFOLFOX6 in people with Advanced Solid Tumors, run by Shanghai Henlius Biotech at 1 site in China.

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 11 inclusion and 18 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: finished, as of the sponsor's last update on 12 Apr 2023. 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 China. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose of HLX07 combined with different chemotherapy regimen (time frame: up to 24 months). 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 NCT03577704, 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 12 Apr 2023.

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