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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HLX43, an experimental therapy, to determine the optimal dose and its effectiveness for people with advanced non-small cell lung cancer (NSCLC). The goal is to assess its safety and patient tolerance. Two different doses are being tested to identify the more effective option. Suitable participants have NSCLC that cannot be fully removed with surgery and have not responded to standard treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that HLX43 is likely to be safe for humans?

Research has shown that HLX43 was safe in earlier studies. Animal tests suggested that HLX43 was well-tolerated in non-small cell lung cancer (NSCLC) and other cancers. In early human trials, participants tolerated different doses well, with no unexpected safety issues. This indicates that HLX43 could be a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Researchers are excited about HLX43 because it offers a new approach to treating non-small cell lung cancer (NSCLC). Unlike traditional chemotherapy, which targets rapidly dividing cells indiscriminately, HLX43 is designed to specifically target and bind to cancer cells, potentially minimizing damage to healthy cells. This specificity could lead to fewer side effects and improved tolerability for patients. Additionally, HLX43 is administered every three weeks, which might offer a more convenient treatment schedule compared to more frequent standard therapies. These unique features make HLX43 a promising candidate in the fight against NSCLC.

What evidence suggests that HLX43 might be an effective treatment for non-small cell lung cancer?

Research has shown that HLX43 has promising effects in fighting tumors and is safe for treating non-small cell lung cancer (NSCLC). In earlier studies, patients tolerated HLX43 well, with no new safety issues, and the treatment showed early signs of effectiveness. One study found that HLX43 was safe to use and demonstrated initial anti-tumor activity in patients with advanced NSCLC. Additionally, early research suggested that HLX43 might work well against various cancers, including NSCLC. In this trial, participants will receive one of two doses of HLX43 to further evaluate its safety and effectiveness. Overall, these findings support the potential of HLX43 to be effective for NSCLC. ^{1 2 3 6 7}

Who Is on the Research Team?

Fred Hirsch, Dr

Principal Investigator

Mount Sinai Health System

Jie He, Dr

Principal Investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Jie Wang, Dr

Principal Investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: HLX43 DOSE 2 (2.5 mg/kg) 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 (2.0 mg/kg) 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+

Henlius USA Inc.

Collaborator

Citations

1. henlius.com henlius.com/en/NewsDetails-5539-26.html

Henlius Presents Updated Clinical Data on PD-L1 ADC ... Preclinical data have shown that, HLX43 has good anti-tumor effects and a favorable tolerability profile in NSCLC, cervical cancer (CC), ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3025

A phase I clinical study to evaluate the safety, tolerability ... Conclusions: HLX43 was well tolerated with no new safety signals across different dose and exhibited encouraging preliminary efficacy in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06907615

A Phase II Clinical Study to Evaluate HLX43 in Subjects ... This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1556086425022002

PT2.10.03 Safety, Tolerability and Preliminary Efficacy of ... HLX43 demonstrated a manageable safety profile and preliminary antitumor activity in patients with advanced NSCLC who were refractory to ...

5. onclive.com onclive.com/view/hlx43-nets-fda-orphan-drug-designation-in-thymic-epithelial-tumors

HLX43 Nets FDA Orphan Drug Designation in Thymic ... The disease control rate was 87.0% (95% CI, 75.1%-94.6%). The median progression-free survival (PFS) was 5.4 months (95% CI, 4.0-5.8). Notably, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1556086425022002

PT2.10.03 Safety, Tolerability and Preliminary Efficacy of ... Preclinical data showed tumor regression of HLX43 in PD-(L)1 inhibitor-resistant non-small cell lung cancer (NSCLC) and esophageal squamous cell ...

7. jto.org jto.org/article/S1556-0864(25)02200-2/abstract

PT2.10.03 Safety, Tolerability and Preliminary Efficacy of ... This study aims to evaluate the safety, tolerability, and preliminary efficacy of HLX43 in patients with advanced solid tumors who have failed standard ...