HLX43 for Non-Small Cell Lung Cancer

Recruiting at 1 trial location

Overseen By Jie He, Dr

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Shanghai Henlius Biotech

Must not be taking: Topoisomerase I inhibitors, Corticosteroids

Disqualifiers: Small cell lung cancer, Cardiovascular, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to 24 months

243 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you must not have used certain medications like moderate or potent CYP2D6 or CYP3A inhibitors or inducers, systemic corticosteroids, or immunosuppressants within 2 weeks before joining the trial.

Eligibility Criteria

This trial is for adults with advanced Non-small Cell Lung Cancer who've had prior treatments fail, including PD-(L)1 and platinum-based chemotherapy or targeted therapy. Participants need at least one measurable tumor lesion, must provide tissue samples for testing, have a good performance status (ECOG PS 0-1), expected to live more than 3 months, and have adequate organ function. They should not be undergoing certain other treatments recently and agree to use effective contraception.

Inclusion Criteria

My cancer did not respond to standard treatments including PD-1/PD-L1 inhibitors and platinum chemotherapy.

* Prior standard treatment failure, including at least targeted therapy for driver gene alterations (patients with EGFR mutations must be previously treated with EGFR inhibitors) and platinum-based chemotherapy; 4. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization; 5. Subjects who agree to provide archived tumor tissue specimens that meets the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing; 6. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 2 weeks from the previous hormone therapy or small molecular targeted therapy; at least 1 week from the administration of the traditional Chinese medicine for anti-cancer indications or minor surgery; and recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v5.0, except for Grade 2 peripheral neurotoxicity and alopecia); 7. ECOG PS score of 0-1 within 1 week prior to randomization; 8. Life expectancy \> 3 months; 9. Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with granulocyte colony-stimulating factor is allowed within 14 days prior to the first dose) 10. Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HLX43 at different doses via intravenous infusion every 3 weeks until disease progression or other specified conditions

Up to 24 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• HLX43

Trial Overview The study tests two different doses of HLX43 (Anti-PD-L1 ADC) to find the best dose and assess its effectiveness, safety, and tolerability in treating NSCLC. It's a Phase II trial which means it focuses on the drug's efficacy while continuing to monitor side effects from a smaller group of participants.

Participant Groups

Group I: HLX43 DOSE 2 Experimental Treatment 1 Intervention

Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)

Group II: HLX43 DOSE 1 Experimental Treatment 1 Intervention

Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)

Who Is Running the Clinical Trial?

Shanghai Henlius Biotech

Lead Sponsor

Trials

100

Recruited

19,200+

Dr. Jason Zhu

Shanghai Henlius Biotech

Chief Executive Officer since 2023

MBA from Yale University

Dr. Jun Zhu

Shanghai Henlius Biotech

Chief Medical Officer

MD from an unspecified institution

Henlius USA

Collaborator

Trials

1

Recruited

550+