HLX43 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called HLX43 for individuals with advanced or metastatic solid tumors. The primary goal is to assess the safety and tolerability of HLX43 and understand its behavior in the body. The trial includes different groups: one for any solid tumors and others specifically for types of lung cancer (NSCLC) and thymic carcinoma, particularly for those who have not responded to standard treatments. Suitable candidates have solid tumors that have spread, and their current treatments are ineffective or unavailable. As a Phase 1 trial, this research focuses on understanding how HLX43 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there are requirements for a certain period without specific treatments before starting the trial, such as 28 days from major treatments and 14 days from certain drug therapies.
Is there any evidence suggesting that HLX43 is likely to be safe for humans?
Research has shown that HLX43 is generally well-tolerated. In earlier studies, patients did not encounter any new safety concerns at different doses. Some early results indicated that HLX43 had a manageable safety profile, with side effects that were not too severe. Patients with advanced cancers experienced some treatment-related side effects, but these were expected.
Overall, the safety findings suggest HLX43 is tolerable for most patients. However, like any new treatment, there are risks. It is important to remember that this information comes from early studies, so more research is needed to fully understand the safety of HLX43.12345Why do researchers think this study treatment might be promising?
HLX43 is unique because it takes a novel approach to treating advanced and metastatic cancers. Unlike the standard treatments like chemotherapy and targeted therapies that attack cancer cells broadly or focus on known mutations, HLX43 specifically targets certain markers on cancer cells that are often hard to reach with existing drugs. Researchers are excited about HLX43 because it has the potential to effectively treat cancers that have become resistant to current treatments, offering new hope for patients with limited options.
What evidence suggests that HLX43 might be an effective treatment for advanced/metastatic solid tumors?
Research has shown that HLX43 may help treat advanced solid tumors, such as non-small cell lung cancer (NSCLC) and thymic carcinoma. In this trial, participants will join different treatment arms, including those with advanced/metastatic solid tumors, NSCLC, and thymic carcinoma. One study found that HLX43 stopped disease progression in 87% of patients with thymic tumors. On average, these patients lived 5.4 months without disease worsening. Early results also suggest that HLX43 effectively targets tumors and is generally safe, with most patients not experiencing severe side effects. These findings offer promise for those considering trials for advanced cancers.23678
Who Is on the Research Team?
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 aged 18-75 with advanced or metastatic solid tumors, including certain types of lung cancer and thyroid cancer, who have tried standard treatments without success or have no other treatment options. Participants must be in good general health, able to provide tumor samples, and have working major organs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive HLX43 at escalating doses via intravenous infusion to determine the maximum tolerated dose (MTD).
Dose Expansion
Participants are grouped into cohorts based on cancer type to receive the recommended phase 2 dose (RP2D) of HLX43.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- HLX43
Trial Overview
The study is testing a new drug called HLX43 (sometimes with HLX10) to see if it is safe and how the body processes it in people with advanced cancers. It’s an early-phase (Phase I), open-label trial where everyone knows what they are getting.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Patients with advanced/metastatic Thymic carcinoma, who are refractory to first line platinum based standard treatment.
Patients with stage IIIB, IIIC, or IV NSCLC that cannot be treated with surgery or radiotherapy, positive PD-L1 expression and no EGFR sensitizing mutation or ALK/ROS gene rearrangement, no previous systemic anti-tumor therapy for NSCLC.
Patients with advanced/metastatic NSCLC, who are refractory to standard treatment, or for which no standard treatment is available.
Patients with advanced/metastatic NSCLC, who are refractory to standard treatment and docetaxel.
Patients with advanced/metastatic solid tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai Henlius Biotech
Lead Sponsor
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
Citations
The Updated Clinical Results for PD-L1 ADC HLX43 at ...
The updated data further validated HLX43's outstanding efficacy in advanced/ metastatic solid tumors such as non-small cell lung cancer (NSCLC).
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, ...
NCT06115642 | A Phase I Study to Evaluate the Safety, ...
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX43 in patients ...
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 ...
Henlius Receives Orphan Drug Designation for PD-L1 ...
Preclinical data have shown that, HLX43 has good anti-tumor effects and a favorable tolerability profile in NSCLC, cervical cancer (CC), ...
Results from the Phase 1 Clinical Trial of Henlius PD-L1 ...
The results indicated that HLX43 was well tolerated with no new safety signals across different dose and exhibited encouraging preliminary efficacy in patients ...
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 ...
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), ...
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