Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX316 in Participants With Advanced or Metastatic Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2026-05-28
41
Participants Needed
5
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HLX316, a B7-H3 targeting sialidase Fc fusion protein, in people with advanced or metastatic solid tumors, including platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This early Phase I trial aims to assess the safety, tolerability, how the body processes the drug, and its preliminary ability to affect tumors. The study includes two parts: a dose-escalation phase and a dose-expansion phase focusing on determining effective dose levels and early treatment effects. Participants will receive HLX316 through intravenous infusion once weekly at varying dose levels (1, 3, 10, 20, or 30 mg/kg). The initial dose-escalation phase will assign participants to different dose groups to evaluate safety and pharmacokinetics. Based on these results, the second phase will expand dosing at selected levels, tentatively 10 mg/kg and 20 mg/kg, to further explore treatment effects. Treatment cycles repeat every week as part of this process. Throughout the study, participants will undergo regular safety assessments to monitor side effects and dose-limiting toxicities during a 21-day evaluation period. Effectiveness will be measured by tumor response rates over six months, with ongoing monitoring of duration of response, progression-free survival, and overall survival up to 24 months. Laboratory tests, imaging, and tumor tissue analysis will help researchers understand the drug's effects and participant health. The trial may last up to several years with continuous safety and efficacy evaluations.
CONDITIONS
Brief Title
A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study details and willing to sign informed consent
- Aged 18 years or older
- Histologically or cytologically confirmed advanced or metastatic solid tumors with prior standard therapy failure or no effective standard therapy available
- At least one measurable lesion per RECIST v1.1 within 4 weeks before first dose
- ECOG performance status of 0 or 1 within 7 days before first dose
- Expected survival longer than 3 months
- Adequate time elapsed since prior major surgery, radiotherapy, chemotherapy, immunotherapy, or biologic therapy with recovery from related adverse events
- Willing to provide tumor tissue samples for testing
- Adequate organ and coagulation function based on recent laboratory tests
- Agree to use effective contraception during study and for 6 months after last dose if of childbearing potential
- Tumor type includes platinum-resistant ovarian cancer or other advanced solid tumors with B7-H3 expression
- For ovarian, primary peritoneal, or fallopian tube cancer: confirmed epithelial cancer type, at least 2 prior therapies including platinum, and platinum-resistant disease as defined
You will not qualify if you...
- History of arterial thromboembolism, stroke, or transient ischemic attack within past 12 months
- Symptomatic chronic heart failure or arrhythmia requiring treatment
- Recent myocardial infarction or unstable angina within 6 months
- Active infection requiring intravenous antibiotics or recent treatment within 7 days
- Active bleeding or bleeding tendency within 7 days
- Serious or non-healing wounds or fractures within 7 days
- Prior participation in this study
- Current participation in another clinical study (except certain observational studies)
- Recent receipt of other therapy within 3 weeks or 5 half-lives
- Known HIV infection
- Active untreated syphilis or hepatitis B or C infection (with some exceptions for controlled infections)
- Untreated or unstable central nervous system metastases
- Autoimmune disease requiring systemic immunosuppressive therapy
- Recent systemic corticosteroid use within 4 weeks
- Other serious illnesses or conditions making participation inappropriate
- Unable or unwilling to follow study protocol
- Other recent primary malignancy without curative treatment
- Any condition interfering with drug evaluation or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months depending on individual response and tolerance
Participants receive HLX316 by intravenous infusion once weekly in cycles of 1 week.
Weekly visits for infusion
Duration - Up to 24 months after treatment
Participants are monitored for safety, pharmacokinetics, and efficacy after treatment ends.
Periodic visits as scheduled by study staff
Trial Site Locations
Total: 5 locations
1
Chongqing Cancer Hospital
Chongqing, China
Not Yet Recruiting
2
Jinan Central Clinical College of Shandong First Medical University
Jinan, China
Not Yet Recruiting
3
Shandong Cancer Hospital
Jinan, China
Actively Recruiting
4
Obstetris &Gynecology Hospital of Fudan University
Shanghai, China
Not Yet Recruiting
5
Hubei Cancer Hospital
Wuhan, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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