Solid Tumor and NSCLCPhase 1NCT06210815
A Study of HLX42 in Advanced/Metastatic Solid Tumors
A Phase 1 study testing HLX42 in people with Solid Tumor and NSCLC, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor and NSCLC
- What is being tested?
- HLX42
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to 14 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Patients with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 1); Patients with histologically or cytologically confirmed advanced/metastatic malignant NSCLC, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 2);
- At least one measurable lesion as per RECIST 1.1；
- An ECOG performance status score of 0-1；
- Life expectancy > 3 months;
- Adequate organ functions as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product;
- For patients with hepatocellular carcinoma, Child-Pugh score must be A;
Who cannot join
- History of other malignant tumors within 2 years prior to the first administration, except for cured cervical carcinoma in situ or cutaneous basal cell carcinoma;
- The histopathological type is large cell carcinoma, adenosquamous carcinoma, other types (including but not limited to sarcomatoid carcinoma, lymphoepithelioma-like carcinoma, NUT carcinoma, etc.), or contains neuroendocrine pathological components, etc. (stage 2)；
- History of (non-infectious) ILD requiring the use of steroids, current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
- Subjects who are allergic to protein preparations/ monoclonal antibodies/ any component in the formulation of the investigational product;
- Subjects with known previous serious eye disorders;
- Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;
Show all 14Show fewer
- Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases;
- Patients who have been assessed as unsuitable for inclusion by the investigator, due to brain metastases, spinal cord compression, or cancerous meningitis with clinical symptoms, or uncontrolled brain or spinal cord metastases that have been evidenced;
- Patients who have received long-term systemic steroids treatment (equivalent to prednisone > 10 mg/day) or immunosuppressive agents of any other forms, which should be discontinued at least 2 weeks prior to the first infusion of the investigational product;
- Patients who have used potent CYP2D6/CYP3A inhibitors or inducers within 2 weeks prior to the first administration;
- Patients who have history of immunodeficiency, including HIV infection or other acquired or congenital immunodeficiencies, or history of organ transplantation;
- Patients with active HBV or HCV infection or HBV/HCV co-infection;
- Pregnant or lactating women;
- Subjects who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangdong, Guangzhou
Huajun Chen, Dr.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX42 (Anti-EGFR ADC) in Patients With Advanced/Metastatic Solid Tumors
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
Read the detailed description
The first stage: This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42 with escalated doses in the treatment of patients with advanced/metastatic solid tumors. In this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX42 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX42.
The second stage: This is a randimazation, open label, 2 arms, muticentral clinical study, about 30 patients in each arm, the total sample size is about 60. Eligible subjects will be randomized in a 1:1 ratio: Group A: HLX42 2.5 mg/kg; Group B: HLX42 2.0 mg/kg. Stratification: tumor tissue type(adenocarcinoma or squamous carcinoma), EGFR-sensitive mutation status (mutant or wild-type or missing).
- Conditions
- Solid Tumor and NSCLC
- Being tested
- HLX42
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX42Drug
Also called Anti-EGFR ADC
HLX42 is an anti-EGFR monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
| Study group | Role | What they receive |
|---|---|---|
| HLX42 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until progressive disease (PD) without any clinical benefit, initiation of other anti-tumor therapies, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first). Receives: Drug: HLX42 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dose-Limiting Toxicity (DLT) of HLX42 within 21 days after the first Administration
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 21 days after the first administration of HLX42.
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
The maximum tolerated dose (MTD) of HLX42
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX42.
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
Secondary outcomes (10)
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Measured: approximately up to 24 months
Duration of response (DOR)
Length of time response continued based on investigator's assessment.
Measured: approximately up to 24 months.
Progression-free survival (PFS)
The PFS is defined as the time from the date of enrollment to the date of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause,whichever occurred first.
Measured: up to approximately up to 24 months
Overall survival (OS)
Time from the date of enrollment to the date of death for any cause.
Measured: approximately up to 24 months
Cmax
Maximum serum concentration (Cmax) of HLX42.
Measured: Up to 21 days after the first dose
Tmax
Time to maximum serum concentration (Tmax) of HLX42.
Measured: Up to 21 days after the first dose
T1/2
Half-life (T1/2) of HLX42.
Measured: Up to 21 days after the first dose
ADA (anti-drug antibody)
Incidence and titer of ADA of HLX42.
Measured: approximately up to 24 months
Nab (neutralizing antibody)
Incidence and titer of Nab of HLX42.
Measured: approximately up to 24 months
Number of subjects experiencing adverse events
Frequency and seriousness of treatment emergent adverse events (TEAEs).
Measured: Day 1 through 90 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start14 Mar 2024
- Primary completion2 Sep 2026 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor and NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Dr., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210815
- Sponsor's protocol ID
- HLX42-FIH101
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX42 (Anti-EGFR ADC) in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06210815
- Acronym / sponsor ID
- HLX42-FIH101
- Conditions
- Solid Tumor and NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
Detailed description
The first stage: This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42 with escalated doses in the treatment of patients with advanced/metastatic solid tumors. In this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX42 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX42.
The second stage: This is a randimazation, open label, 2 arms, muticentral clinical study, about 30 patients in each arm, the total sample size is about 60. Eligible subjects will be randomized in a 1:1 ratio: Group A: HLX42 2.5 mg/kg; Group B: HLX42 2.0 mg/kg. Stratification: tumor tissue type(adenocarcinoma or squamous carcinoma), EGFR-sensitive mutation status (mutant or wild-type or missing).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX42 | Experimental | Drug: HLX42Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until progressive disease (PD) without any clinical benefit, initiation of other anti-tumor therapies, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Patients with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 1); Patients with histologically or cytologically confirmed advanced/metastatic malignant NSCLC, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 2);
- At least one measurable lesion as per RECIST 1.1；
- An ECOG performance status score of 0-1；
- Life expectancy > 3 months;
Key exclusion criteria (14 listed)
- History of other malignant tumors within 2 years prior to the first administration, except for cured cervical carcinoma in situ or cutaneous basal cell carcinoma;
- The histopathological type is large cell carcinoma, adenosquamous carcinoma, other types (including but not limited to sarcomatoid carcinoma, lymphoepithelioma-like carcinoma, NUT carcinoma, etc.), or contains neuroendocrine pathological components, etc. (stage 2)；
- History of (non-infectious) ILD requiring the use of steroids, current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
- Subjects who are allergic to protein preparations/ monoclonal antibodies/ any component in the formulation of the investigational product;
- Subjects with known previous serious eye disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX42Also: Anti-EGFR ADCHLX42 is an anti-EGFR monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX42 |
Primary outcome
The Dose-Limiting Toxicity (DLT) of HLX42 within 21 days after the first Administration
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 21 days after the first administration of HLX42.
The maximum tolerated dose (MTD) of HLX42
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX42.
10 secondary outcomes
Objective response rate (ORR)
Time frame: approximately up to 24 months
Duration of response (DOR)
Time frame: approximately up to 24 months.
Progression-free survival (PFS)
Time frame: up to approximately up to 24 months
Overall survival (OS)
Time frame: approximately up to 24 months
Cmax
Time frame: Up to 21 days after the first dose
Tmax
Time frame: Up to 21 days after the first dose
T1/2
Time frame: Up to 21 days after the first dose
ADA (anti-drug antibody)
Time frame: approximately up to 24 months
Nab (neutralizing antibody)
Time frame: approximately up to 24 months
Number of subjects experiencing adverse events
Time frame: Day 1 through 90 days after last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor and NSCLC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yilong Wu, Dr. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX42 in people with Solid Tumor and NSCLC, run by Shanghai Henlius Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilong Wu, Dr. (020-83827812, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dose-Limiting Toxicity (DLT) of HLX42 within 21 days after the first Administration (time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.