A Multicenter, Single-arm, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of HC010 for Injection in the First-line Treatment of Advanced Non-small Cell Lung Cancer Positive for Programmed Death Ligand-1 (PD-L1)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection in patients with positive PD-L1 (TPS ≥1%)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Voluntarily participate in the study, communicate well with investigators, understand and voluntarily complete the study process according to this protocol, and sign the informed consent form (ICF).

• 2\. Male or female, aged ≥ 18 years at the time of signing the informed consent form.

• 3\. Histologically or cytologically confirmed locally advanced or metastatic (stage IIIb\

⁃ IV) NSCLC (United States Cancer Confederation \[AJCC\] 8th edition), positive PD-L1 expression confirmed by IHC with central laboratory or local test results.

• 4\. Not previously receiving systemic therapy for locally advanced or metastatic NSCLC; not allowed if the last dose of prior treatment is \<6 months from disease recurrence in subjects who received prior adjuvant or neoadjuvant therapy.

• 5\. No EGFR mutation/ROS1 rearrangement/ALK rearrangement. If other targeted mutations such as BRAF V600E mutation/NTRK1/2/3 gene fusion/MET14 exon skipping mutation/RET rearrangement positive are known, they will not be included in this study if the corresponding targeted therapy drugs have been approved.

• 6\. Expected survival ≥ 3 months.

• 7.There should be at least one measurable lesion according to RECIST v1.1; radiotherapy-experienced lesions may not be selected as target lesions, unless the radiotherapy lesion is the only measurable lesion and clearly progresses based on imaging judgment.

• 8\. Eastern Cooperative Oncology Group (ECOG) performance status scored 0 or 1 in the United States and did not worsen within one week prior to first dose.

• 9\. Subjects (both female and male) agreed to use effective contraception from signing the ICF until 180 days after last dose of investigational product. Female patients of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose; females who are not pregnant or lactating from signing informed consent until 6 months after the last use of investigational drug (including those who agree to stop breastfeeding during this period).

Locations
Other Locations
China
Shanghai East Hospital
RECRUITING
Shanghai
Contact Information
Primary
QiQi Huang, master
qiqi.huang@btyy.com
18221247718
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 50
Treatments
Experimental: HC010
Sponsors
Leads: HC Biopharma Inc.

This content was sourced from clinicaltrials.gov