Solid TumorPhase 1NCT05360368
HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing HLX07 in people with Solid Tumor, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HLX07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 28 Feb 2024
- 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
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
- Aged ≥ 18 years, ≤ 75 years;
- Patients must have histologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- Measurable disease according to RECIST Version 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Expected survival 12 weeks;
- Adequate organ function;
- For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose;
Who cannot join
- Prior anti-EGFR (including EGFR ADC) monoclonal antibody therapy;
- A history of other malignancies within two years, except for cured Localized tumor;
- Participants with any prior allogeneic solid organ or bone marrow transplantations;
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable);
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Active clinical severe infection;
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University shanghai cancer center
Shanghai, 200000
Jian Zhang, MD, 021-64175590, neck130@hotmail.com
About this study
Official title: A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors
This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.
- Conditions
- Solid Tumor
- Being tested
- HLX07
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07Drug
Also called Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection
A Recombinant Humanized Anti-EGFR Monoclonal Antibody, HLX07 will be administered as a single intravenous (IV) infusion on Day 1 in each 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| HLX07 | Experimental | This study uses the "3+3" design to investigate the safety and determine the MTD of HLX07. Four dose levels of 800 mg, 1200 mg, 1500 mg and 1800 mg are planned for dose finding. Enrollment will continue until a maximum of 24 patients are enrolled. Receives: Drug: HLX07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Treatment-Related Adverse Events
Measured: 2 years
The proportion of patients experiencing dose limiting toxicity (DLT) events
Measured: from first dose to the end of Cycle 1 (each cycle is 21 days)
The maximum tolerated dose (MTD)
Measured: from first dose to the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes (11)
Peak plasma concentration (Cmax) of HLX07
Measured: 2 years
Time to peak (Tmax) of HLX07
Measured: 2 years
Area under the concentration-time curve (AUC) of HLX07
Measured: 2 years
Elimination half-life (t1/2) of HLX07
Measured: 2 years
Clearance (CL) of HLX07
Measured: 2 years
Volume of distribution (Vz) of HLX07
Measured: 2 years
Accumulation Index (Rac) of HLX07
Measured: 2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)
Measured: 2 years
Objective response rate (ORR)
Measured: 2 years
Disease control rate (DCR)
Measured: 2 years
Duration of response (DOR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start30 Mar 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360368
- Sponsor's protocol ID
- HLX07-103
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05360368
- Acronym / sponsor ID
- HLX07-103
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 4 May 2022 (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.
This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX07 | Experimental | Drug: HLX07This study uses the "3+3" design to investigate the safety and determine the MTD of HLX07. Four dose levels of 800 mg, 1200 mg, 1500 mg and 1800 mg are planned for dose finding. Enrollment will continue until a maximum of 24 patients are enrolled. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
- Aged ≥ 18 years, ≤ 75 years;
- Patients must have histologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- Measurable disease according to RECIST Version 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Key exclusion criteria (6 listed)
- Prior anti-EGFR (including EGFR ADC) monoclonal antibody therapy;
- A history of other malignancies within two years, except for cured Localized tumor;
- Participants with any prior allogeneic solid organ or bone marrow transplantations;
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable);
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
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 |
|---|---|---|
| HLX07Also: Recombinant Humanized Anti-EGFR Monoclonal Antibody InjectionA Recombinant Humanized Anti-EGFR Monoclonal Antibody, HLX07 will be administered as a single intravenous (IV) infusion on Day 1 in each 3-week cycle | Drug | HLX07 |
Primary outcome
The Incidence of Treatment-Related Adverse Events
Time frame: 2 years
The proportion of patients experiencing dose limiting toxicity (DLT) events
Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
The maximum tolerated dose (MTD)
Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
11 secondary outcomes
Peak plasma concentration (Cmax) of HLX07
Time frame: 2 years
Time to peak (Tmax) of HLX07
Time frame: 2 years
Area under the concentration-time curve (AUC) of HLX07
Time frame: 2 years
Elimination half-life (t1/2) of HLX07
Time frame: 2 years
Clearance (CL) of HLX07
Time frame: 2 years
Volume of distribution (Vz) of HLX07
Time frame: 2 years
Accumulation Index (Rac) of HLX07
Time frame: 2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 HLX07 in people with Solid Tumor, 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 8 inclusion and 6 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 5 May 2022. 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 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 Xuhui Hu, MD (18618313742, Xuhui_Hu@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Treatment-Related Adverse Events (time frame: 2 years). The study lists 3 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 5 May 2022.