Advanced/Metastatic Solid TumorsPhase 1NCT07473726
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors
A Phase 1 study testing HLX48 in people with Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 7 sites in 2 countries.
Trial summary
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX48 in patients with advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- HLX48
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 30 Jun 2026to Aug 2028
- 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
- Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Participants with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who have failed or have no available standard treatment;
- At least one measurable lesion as per RECIST v1.1 within 4 weeks prior to the first dose;
- An ECOG performance status score of 0-1 within 7 days prior to the first dose;
- Expected survival > 3 months;
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- The following conditions should be met in terms of the time of the first dose of the investigational product: at least 28 days (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 14 days from the previous small molecule targeted drug therapy, hormone therapy, or administration of the traditional Chinese medicine for anti-tumor indications; at least 7 days from paracentesis and other minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v6.0, except for alopecia, well-controlled abnormal thyroid function and type 1 diabetes mellitus);
- Availability of archival tumor tissue specimen (from the most recent surgery or biopsy, preferably within 2 years) meeting assay requirements, or agreement to undergo biopsy for tumor tissue collection for assessment of EGFR and c-MET protein expression;
- Adequate organ function as confirmed by laboratory tests within 7 days prior to the first dose of the investigational product (no blood transfusions or treatment with granulocyte colony-stimulating factor within 14 days prior to the first dose);
- For participants with hepatocellular carcinoma, Child-Pugh score must be A;
- Male and female participants with reproductive 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 participants of childbearing potential must receive pregnancy test within 7 days prior to enrollment to rule out pregnancy.
Who cannot join
- History of other malignant tumors within 2 years prior to first dose, except radically treated early-stage malignant tumors (carcinoma in situ or stage I tumors), such as cured cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
- History of serious ocular diseases, including: (1) keratoconjunctivitis sicca; (2) severe keratopathy; (3) moderate or severe xerophthalmia;
- History of (non-infectious) interstitial lung disease (ILD) requiring use of steroids, or current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
- Known history of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or allergy to any component in the formulation of the investigational product; previous exposure to ADCs with topoisomerase I inhibitors as payload;
- Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first dose of the investigational product;
- Patients who have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.;
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- Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) < 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after active treatment); (6) pericarditis or uncontrolled pericardial effusion; (7) myocarditis;
- Assessed as unsuitable for inclusion by the investigator, due to newly developed or clinically symptomatic brain or meningeal metastases, spinal cord compression, or cancerous meningitis, or uncontrolled brain or spinal cord metastases that have been evidenced;
- Participants with known active or suspected autoimmune diseases. Participants with autoimmune-related hypothyroidism who are receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;
- Presence of unhealed skin lesions, including but not limited to (1) major traumatic injury within 4 weeks prior to the first dose (for paracentesis and other minor surgery, the investigator must confirm that the skin has healed prior to the first dose); (2) planned major surgery during treatment with the investigational product or within 6 months after the last dose;
- Presence of uncontrollable pleural effusion or pericardial effusion after appropriate intervention, or ascites requiring repeated drainage (once a month or more frequently);
- Use of strong inhibitors or inducers of CYP3A within 2 weeks prior to the first dose;
- Patients with active tuberculosis;
- Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;
- Patients with active HBV or HCV infection or HBV/HCV co-infection;
- Pregnant or lactating women;
- Participants 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
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
China4 sites, 4 recruiting
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Ting Wei, 86-20-61643888, 258077534@qq.com
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangzhou, 716099
SUN YAT-SEN UNIVERSITY CANCER CENTER, 86-20-87343468, Emailxurh@sysucc.org.cn
- Recruiting
Shanghai General Hospital
Hongkou, Shanghai Municipality, 200080
Qi Li, 86-21-63240090, leeqi2001@hotmail.com
- Not yet recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000
Xin Wang, 86-351-4881611, WXCAMS@126.com
Australia3 sites, 3 recruiting
- Not yet recruiting
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Vinod Ganju, +61 3 9781 5244, vg@paso.com.au
- Not yet recruiting
Macquarie University
North Ryde, New South Wales, 2109
Wei Yen Chan, +61 4 30831180, weiyen.chan@mqhealth.org.au
- Not yet recruiting
GenesisCare St.Leonards
Saint Leonards, New South Wales, 2065
Nick Pavlakis, +61 2 80374100, Nick.Pavlakis@genesiscare.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX48 (EGFR/c-MET Bispecific Antibody-Drug Conjugate) in Participants With Advanced/Metastatic Solid Tumors
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX48 in patients with advanced/metastatic solid tumors.
Read the detailed description
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX48 with escalated doses in the treatment of participants with advanced/metastatic solid tumors. In this study, a 3+3 dose escalation method will be adopted, and the participants will be administered HLX48 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first dose of HLX48. To ensure the safety of participants, the Safety Review Committee (SRC) will review all safety data from all participants in the current cohort before deciding to proceed to the next cohort to include more participants. The SRC will review all safety data collected in the cohort to confirm that there are no unexpected, significant, or unacceptable risks to participants. Based on the evaluation results, the SRC will make recommendations on participant eligibility and dose levels, and vote on whether to start enrollment and treatment for the next cohort. If necessary, the investigator and the sponsor will discuss the need to add a new dose group based on the available data on safety, tolerability, PK, immunogenicity, and efficacy. If a participant withdraws from the study within the DLT observation period due to reasons other than therapeutic toxicity, he/she will be replaced by a new participant.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- HLX48
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX48Drug
EGFR/c-MET Bispecific Antibody-Drug Conjugate
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | A total of six dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6. Receives: Drug: HLX48 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dose-Limiting Toxicity (DLT) of HLX48 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 HLX48.
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
The maximum tolerated dose (MTD) of HLX48
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX48
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
Secondary outcomes (9)
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: 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 HLX48.
Measured: Up to 21 days after the first dose
Tmax
Time to maximum serum concentration (Tmax) of HLX48.
Measured: Up to 21 days after the first dose
T1/2
Half-life (T1/2) of HLX48.
Measured: Up to 21 days after the first dose
ADA (anti-drug antibody)
Incidence and titer of ADA of HLX48.
Measured: approximately up to 24 months
Nab (neutralizing antibody)
Incidence and titer of Nab of HLX48.
Measured: approximately up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start30 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Solid TumorsStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473726
- Sponsor's protocol ID
- HLX48-FIH101
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. 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 HLX48 (EGFR/c-MET Bispecific Antibody-Drug Conjugate) in Participants With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07473726
- Acronym / sponsor ID
- HLX48-FIH101
- Conditions
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Mar 2026 (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, tolerability, and pharmacokinetic characteristics of HLX48 in patients with advanced/metastatic solid tumors.
Detailed description
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX48 with escalated doses in the treatment of participants with advanced/metastatic solid tumors. In this study, a 3+3 dose escalation method will be adopted, and the participants will be administered HLX48 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first dose of HLX48. To ensure the safety of participants, the Safety Review Committee (SRC) will review all safety data from all participants in the current cohort before deciding to proceed to the next cohort to include more participants. The SRC will review all safety data collected in the cohort to confirm that there are no unexpected, significant, or unacceptable risks to participants. Based on the evaluation results, the SRC will make recommendations on participant eligibility and dose levels, and vote on whether to start enrollment and treatment for the next cohort. If necessary, the investigator and the sponsor will discuss the need to add a new dose group based on the available data on safety, tolerability, PK, immunogenicity, and efficacy. If a participant withdraws from the study within the DLT observation period due to reasons other than therapeutic toxicity, he/she will be replaced by a new participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: HLX48A total of six dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Participants with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who have failed or have no available standard treatment;
- At least one measurable lesion as per RECIST v1.1 within 4 weeks prior to the first dose;
- An ECOG performance status score of 0-1 within 7 days prior to the first dose;
Key exclusion criteria (17 listed)
- History of other malignant tumors within 2 years prior to first dose, except radically treated early-stage malignant tumors (carcinoma in situ or stage I tumors), such as cured cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
- History of serious ocular diseases, including: (1) keratoconjunctivitis sicca; (2) severe keratopathy; (3) moderate or severe xerophthalmia;
- History of (non-infectious) interstitial lung disease (ILD) requiring use of steroids, or current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
- Known history of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or allergy to any component in the formulation of the investigational product; previous exposure to ADCs with topoisomerase I inhibitors as payload;
- Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first dose of the investigational product;
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 |
|---|---|---|
| HLX48EGFR/c-MET Bispecific Antibody-Drug Conjugate | Drug | Dose Escalation |
Primary outcome
The Dose-Limiting Toxicity (DLT) of HLX48 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 HLX48.
The maximum tolerated dose (MTD) of HLX48
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 HLX48
9 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: 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
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 2 Jul 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX48 in people with Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 7 sites in 2 countries.
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 11 inclusion and 17 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Australia. 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 Ruihua Xu (86-20-87343468, Emailxurh@sysucc.org.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 HLX48 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 2 Jul 2026.