Advanced/Metastatic Solid TumorsPhase 1NCT07541534
A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors
A Phase 1 study testing HLX316 in people with Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 5 sites in China.
Trial summary
This study is an open-label, first-in-human Phase I clinical study to evaluate the safety, tolerability, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- HLX316
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesChina
- Study dates
- 22 May 2026to 1 Jun 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the contents, process and possible adverse reactions of the study before the study, sign the informed consent form, voluntarily participate in the study, and be able to complete the study according to the requirements of the study protocol;
- Aged ≥ 18 years at the time of signing ICF;
- Participants with histologically or cytologically confirmed advanced or metastatic solid tumors who have failed at least one line of standard systemic therapy in the advanced or metastatic setting (participants who received neoadjuvant or adjuvant therapy and experienced progressive disease or relapse within 6 months after completion of such therapy will be considered to have failed one line of standard therapy), or for whom no effective standard therapy is available, or who are intolerant of or refuse standard systemic therapy;
- At least 1 measurable lesion per RECIST v1.1 within 4 weeks prior to the first dose; for participants who have received prior radiotherapy, a previously irradiated lesion may be considered a target lesion if it is measurable per RECIST v1.1 and there is objective evidence of significant progression following radiotherapy; brain metastatic lesions may not serve as target lesions;
- ECOG performance status of 0 or 1 within 7 days prior to the first dose;
- Expected survival of more than 3 months;
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- At least 28 days must have elapsed between the first dose of investigational drug and any prior major surgical procedure, medical device treatment, local radiotherapy (except palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biologic therapy; at least 14 days must have elapsed since prior small-molecule targeted therapy or hormonal therapy; at least 7 days must have elapsed since prior traditional Chinese medicine with antitumor indications or minor surgery; and any treatment-related AEs must have recovered to CTCAE v6.0 Grade ≤ 1 (except alopecia);
- The participant agrees to provide archival tumor tissue specimen sufficient to meet testing requirements (from the most recent surgery or biopsy, preferably within 3 years) or agrees to undergo a fresh biopsy for tumor tissue collection (unless the investigator determines that the procedure would pose an unacceptable risk to the participant's safety), for assessment of tumor sialylation and protein expression including B7-H3; Note: Participants are required to provide a formalin-fixed, paraffin-embedded (FFPE) tumor sample (paraffin block or unstained sections, meeting quality control standards for testing) collected from a non-irradiated site at the time of or after the diagnosis of malignancy, from the most recent surgery or biopsy, along with the corresponding pathology report for the above specimen.
- Adequate organ function confirmed by laboratory assessments performed within 7 days prior to the first dose of study drug (without receipt of transfusions, granulocyte colony-stimulating factors, or thrombopoietic agents within 14 days prior to the first dose):
- Hematologic System Absolute neutrophil count (ANC) ≥ 1.0 × 109/L Platelet count (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 90 g/L Liver Function Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), unless a known genetic cause of elevated bilirubin is present (e.g., Gilbert's syndrome) Alanine aminotransferase (ALT) ≤ ULN; ≤ 2.5 × ULN for participants with hepatic metastases or hepatocellular carcinoma Aspartate aminotransferase (AST) ≤ ULN; ≤ 2.5 × ULN for participants with hepatic metastases or hepatocellular carcinoma Renal Function Creatinine (Cr) ≤ 1.5 × ULN; if > 1.5 × ULN, creatinine clearance must be ≥ 40 mL/min (calculated using the Cockcroft-Gault formula) Coagulation Function (unless the participant is receiving anticoagulant therapy) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN Prothrombin time (PT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN
- Male and female participants of childbearing potential must agree to use at least 1 highly effective method of contraception during the study and for at least 6 months after the last dose of investigational drug; female participants of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
- The tumor type for participants with advanced solid tumors may be any of the following:
- Platinum-resistant ovarian cancer
- Other advanced/metastatic solid tumors with B7-H3 expression confirmed by IHC.
- Participants with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer must also meet all of the following criteria:
- Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer, with no evidence of non-epithelial carcinoma, borderline tumor, mucinous carcinoma (or seromucinous carcinoma with a predominant mucinous component), malignant Brenner tumor, or undifferentiated carcinoma.
- Participants must have received at least 2 prior lines of therapy for metastatic ovarian cancer, including at least 1 platinum-based regimen, or must be intolerant to such standard treatments.
- Must be platinum-resistant, defined as progressive disease confirmed by CA-125, clinical, or imaging assessment within 6 months after the last platinum-containing chemotherapy regimen.
Who cannot join
- History of arterial thromboembolic events, stroke, or transient ischemic attack within the past 12 months.
- History of symptomatic chronic heart failure (New York Heart Association [NYHA] Class II-IV or left ventricular ejection fraction [LVEF] < 50%) or history of arrhythmia requiring treatment (including QTc interval ≥ 450 ms in males or ≥ 470 ms in females) (QTc interval calculated using the Fridericia formula).
- History of myocardial infarction or unstable angina within 6 months prior to the first dose of HLX316.
- Evidence of active infection requiring intravenous antibiotic therapy during the screening period, or evidence of active infection requiring treatment within 7 days prior to the first dose of HLX316.
- Active uncontrolled bleeding or bleeding tendency within 7 days prior to HLX316 administration.
- Serious or non-healing wounds, fistulas, skin ulcers, or non-healing fractures within 7 days prior to HLX316 administration.
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- The participant has previously participated in this study.
- The participant is currently participating in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
- Receipt of any other therapy within 3 weeks or 5 half-lives prior to HLX316 administration, whichever is shorter.
- Known infection with human immunodeficiency virus (HIV) (any HIV seropositivity or detectable human immunodeficiency virus type 1 ribonucleic acid [HIV RNA]).
- Active syphilis infection, defined as positive serological test result that has not been adequately treated.
- Active hepatitis B or hepatitis C infection. Participants with well-controlled hepatitis B virus/hepatitis C virus (HBV/HCV) infection may be eligible if the following criteria are met and after discussion with the Medical Monitor (MM):
- Hepatitis B:
- Hepatitis B surface antigen (HBsAg)-positive (chronic HBV infection): participants are eligible if they are receiving antiviral therapy and hepatitis B virus deoxyribonucleic acid (HBV DNA) is controlled/undetectable.
- HBsAg-negative and anti-hepatitis B core (HBc)-positive (resolved prior infection): eligible for enrollment. Prophylactic treatment should be considered and reactivation should be monitored.
- Hepatitis C
- Prior HCV infection that has been successfully cured (ribonucleic acid [RNA] undetectable).
- HCV Ab-positive but RNA-negative (spontaneous clearance).
- Participants with untreated central nervous system (CNS) epidural tumors or metastases, or untreated brain metastases. Known leptomeningeal metastases, or uncontrolled or symptomatic central nervous system (CNS) metastases, manifesting as clinical symptoms, cerebral edema, spinal cord compression, and/or progressive growth. Participants with a history of CNS metastases or spinal cord compression may be enrolled if they have received definitive treatment and are considered clinically stable by the investigator after discontinuation of anticonvulsants and steroids for 8 weeks prior to initiation of study treatment. Participants with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, no brain metastatic lesion with a longest diameter > 1.5 cm, and no significant edema peripheral to brain metastatic lesions) may be enrolled. Brain metastatic lesions will not be designated as target lesions.
- Participants with current or prior autoimmune disease requiring systemic immunosuppressive therapy (including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren's syndrome, and sarcoidosis).
- Current requirement for systemic corticosteroids or use of systemic corticosteroids within 4 weeks prior to enrollment (inhaled corticosteroids are permitted for participants with asthma or chronic obstructive pulmonary disease, as are other non-systemic steroids such as topically administered corticosteroids).
- In the investigator's judgment, the participant has other serious illnesses that make participation in this study inappropriate.
- Participant is unwilling or unable to follow protocol requirements.
- Other primary malignancy within 3 years prior to enrollment that has not been treated with curative intent (the investigator may consider discussion with the Medical Monitor), excluding non-metastatic basal cell/squamous cell carcinoma of the skin or non-muscle-invasive bladder cancer.
- Any condition that, in the investigator's judgment, may interfere with the evaluation of the investigational drug, participant safety, or interpretation of study results.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Chongqing Cancer Hospital
Chongqing
- Not yet recruiting
Jinan Central Clinical College of Shandong First Medical University
Jinan
- Recruiting
Shandong Cancer Hospital
Jinan
Jinming Yu, 0531-67626971, sdyujinming@126.com
- Not yet recruiting
Obstetris &Gynecology Hospital of Fudan University
Shanghai
- Not yet recruiting
Hubei Cancer Hospital
Wuhan
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX316 (B7-H3 Targeting Sialidase Fc Fusion Protein) 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, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced/metastatic solid tumors. The study will consist of 2 parts: a Phase Ia dose-escalation part and a Phase Ib dose-expansion part. Phase Ia and Phase Ib will focus on exploring the preliminary antitumor activity of HLX316 in participants with platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- HLX316
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX316Drug
Participants will receive HLX316 administered by intravenous infusion on D 1 of each cycle, with a cycle length of 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia：Dose Escalation and Backfill | Experimental | HLX316 dose levels of 1, 3, 10, 20, and 30 mg/kg, QW. Participants will be assigned to one of the dose cohorts according to the study schedule. Receives: Drug: HLX316 |
| Phase Ib：Dose Expansion | Experimental | The SRC will recommend dose cohorts for Phase Ib dose expansion based on the safety, efficacy, and PK data from Phase Ia; the tentative dose expansion cohorts are HLX316 10.0 mg/kg and 20 mg/kg administered as intravenous infusion QW. Receives: Drug: HLX316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants within each dose cohort who experience dose-limiting toxicity (DLT) events during the DLT evaluation period
Measured: 21 days
To determine the maximum tolerated dose (MTD) of HLX316
Measured: 18 months
RP2D
The recommended phase 2 dose of HLX316
Measured: 24 months
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Measured: 6 months
Secondary outcomes (10)
AE
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 6.0
Measured: 24 months
PK
maximum concentration (Cmax)
Measured: 24 months
PK
time to maximum concentration (Tmax)
Measured: 24 months
PK
elimination half-life (t1/2)
Measured: 24 months
PK
area under the concentration-time curve (AUC)
Measured: 24 months
PK
volume of distribution (Vz)
Measured: 24 months
PK
,clearance (CL), and accumulation ratio (Rac)
Measured: 24 months
Duration of response (DOR)
DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause
Measured: 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: 24 months
Overall survival (OS)
Time from the date of enrollment to the date of death for any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start22 May 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2029 (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
- Non-randomised
- Intervention model
- Single group
- Model description
- HLX316
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT07541534
- Sponsor's protocol ID
- HLX316-FIH101
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- 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 28 May 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, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX316 (B7-H3 Targeting Sialidase Fc Fusion Protein) in Participants With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07541534
- Acronym / sponsor ID
- HLX316-FIH101
- Conditions
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 22 May 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 21 Apr 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, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced/metastatic solid tumors. The study will consist of 2 parts: a Phase Ia dose-escalation part and a Phase Ib dose-expansion part. Phase Ia and Phase Ib will focus on exploring the preliminary antitumor activity of HLX316 in participants with platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- HLX316
| Arm | Type | Receives |
|---|---|---|
| Phase Ia：Dose Escalation and Backfill | Experimental | Drug: HLX316HLX316 dose levels of 1, 3, 10, 20, and 30 mg/kg, QW. Participants will be assigned to one of the dose cohorts according to the study schedule. |
| Phase Ib：Dose Expansion | Experimental | Drug: HLX316The SRC will recommend dose cohorts for Phase Ib dose expansion based on the safety, efficacy, and PK data from Phase Ia; the tentative dose expansion cohorts are HLX316 10.0 mg/kg and 20 mg/kg administered as intravenous infusion QW. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Fully understand the contents, process and possible adverse reactions of the study before the study, sign the informed consent form, voluntarily participate in the study, and be able to complete the study according to the requirements of the study protocol;
- Aged ≥ 18 years at the time of signing ICF;
- Participants with histologically or cytologically confirmed advanced or metastatic solid tumors who have failed at least one line of standard systemic therapy in the advanced or metastatic setting (participants who received neoadjuvant or adjuvant therapy and experienced progressive disease or relapse within 6 months after completion of such therapy will be considered to have failed one line of standard therapy), or for whom no effective standard therapy is available, or who are intolerant of or refuse standard systemic therapy;
- At least 1 measurable lesion per RECIST v1.1 within 4 weeks prior to the first dose; for participants who have received prior radiotherapy, a previously irradiated lesion may be considered a target lesion if it is measurable per RECIST v1.1 and there is objective evidence of significant progression following radiotherapy; brain metastatic lesions may not serve as target lesions;
- ECOG performance status of 0 or 1 within 7 days prior to the first dose;
Key exclusion criteria (25 listed)
- History of arterial thromboembolic events, stroke, or transient ischemic attack within the past 12 months.
- History of symptomatic chronic heart failure (New York Heart Association [NYHA] Class II-IV or left ventricular ejection fraction [LVEF] < 50%) or history of arrhythmia requiring treatment (including QTc interval ≥ 450 ms in males or ≥ 470 ms in females) (QTc interval calculated using the Fridericia formula).
- History of myocardial infarction or unstable angina within 6 months prior to the first dose of HLX316.
- Evidence of active infection requiring intravenous antibiotic therapy during the screening period, or evidence of active infection requiring treatment within 7 days prior to the first dose of HLX316.
- Active uncontrolled bleeding or bleeding tendency within 7 days prior to HLX316 administration.
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 |
|---|---|---|
| HLX316Participants will receive HLX316 administered by intravenous infusion on D 1 of each cycle, with a cycle length of 1 week. | Drug | Phase Ia：Dose Escalation and Backfill, Phase Ib：Dose Expansion |
Primary outcome
The proportion of participants within each dose cohort who experience dose-limiting toxicity (DLT) events during the DLT evaluation period
Time frame: 21 days
To determine the maximum tolerated dose (MTD) of HLX316
Time frame: 18 months
RP2D
Time frame: 24 months
The recommended phase 2 dose of HLX316
Objective response rate (ORR)
Time frame: 6 months
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
10 secondary outcomes
AE
Time frame: 24 months
PK
Time frame: 24 months
PK
Time frame: 24 months
PK
Time frame: 24 months
PK
Time frame: 24 months
PK
Time frame: 24 months
PK
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 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 28 May 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX316 in people with Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 5 sites 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 18 inclusion and 25 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants within each dose cohort who experience dose-limiting toxicity (DLT) events during the DLT evaluation period (time frame: 21 days). The study lists 4 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 28 May 2026.