Clinical trial NCT05360368: HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 standard therapy, or for whom no standard therapy is available.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;

Primary outcomes:
measure: The Incidence of Treatment-Related Adverse Events
timeFrame: 2 years
measure: The proportion of patients experiencing dose limiting toxicity (DLT) events
timeFrame: from first dose to the end of Cycle 1 (each cycle is 21 days)
measure: The maximum tolerated dose (MTD)
timeFrame: from first dose to the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes:
measure: Peak plasma concentration (Cmax) of HLX07
timeFrame: 2 years
measure: Time to peak (Tmax) of HLX07
timeFrame: 2 years
measure: Area under the concentration-time curve (AUC) of HLX07
timeFrame: 2 years
measure: Elimination half-life (t1/2) of HLX07
timeFrame: 2 years
measure: Clearance (CL) of HLX07
timeFrame: 2 years
measure: Volume of distribution (Vz) of HLX07
timeFrame: 2 years
measure: Accumulation Index (Rac) of HLX07
timeFrame: 2 years
measure: Incidence of treatment-emergent anti-drug antibodies (ADA)
timeFrame: 2 years
measure: Objective response rate (ORR)
timeFrame: 2 years
measure: Disease control rate (DCR)
timeFrame: 2 years
measure: Duration of response (DOR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University shanghai cancer center
Study officials:
References: