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Advanced/Metastatic Malignant Solid TumorsPhase 1NCT06115642

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

A Phase 1 study testing HLX43 and HLX10 in people with Advanced/Metastatic Malignant Solid Tumors, run by Shanghai Henlius Biotech at 14 sites in 3 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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 with advanced/metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HLX43 and HLX10
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
14 sitesin 3 countries
Study dates
24 Nov 2023to 30 Nov 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

  • 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;
  • ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
  • In phase Ia, enroll patients with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who are refractory to standard treatment, or for which no standard treatment is available; In phase Ib Cohort 1: enroll patients with histologically or cytologically confirmed advanced/metastatic NSCLC, who are refractory to standard treatment, or for which no standard treatment is available (The standard treatment for squamous NSCLC is defined as platinum-containing chemotherapy combined with immune checkpoint inhibitor [ICI]. The standard treatment for non-squamous NSCLC with known EGFR mutations is defined as EGFR inhibitors and platinum-containing chemotherapy. The standard treatment for patients with non-squamous NSCLC without EGFR mutations is defined as platinum-containing chemotherapy combined with immune checkpoint inhibitor [ICI] therapy); Cohort 2: enroll patients with histologically or cytologically confirmed advanced/metastatic TC, who are refractory to first line platinum based standard treatment; Cohort 3: enroll patients with histologically or cytologically confirmed advanced/metastatic NSCLC, who are refractory to standard treatment and docetaxel treatment (The standard treatment for squamous NSCLC is defined as platinum-containing chemotherapy combined with immune checkpoint inhibitor [ICI]. The standard treatment for non-squamous NSCLC with known EGFR mutations is defined as EGFR inhibitors and platinum-containing chemotherapy. The standard treatment for patients with non-squamous NSCLC without EGFR mutations is defined as platinum-containing chemotherapy combined with immune checkpoint inhibitor [ICI] therapy); Cohort 4: enroll patients with histologically or cytologically confirmed stage IIIB, IIIC, or IV NSCLC that cannot be treated with surgery or radiotherapy; positive PD-L1 expression (PD-L1 positive is defined as TPS ≥ 1%; PD-L1 expression is subject to the central laboratory result) and no EGFR sensitizing mutation or ALK/ROS gene rearrangement; no previous systemic anti-tumor therapy for NSCLC (Patients who have received adjuvant or neoadjuvant therapy are allowed to be enrolled if the adjuvant/neoadjuvant therapy has been completed at least 6 months before the diagnosis of stage IIIB, IIIC, or IV NSCLC);
  • At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to the first administration;
  • An ECOG performance status score of 0-1 within 7 days prior to the first administration;
  • Life expectancy > 3 months;
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  • The following conditions must be met in terms of the time of the first administration of the investigational product: at least 28 days 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 and previous hormone therapy; at least 7 days from the administration of the traditional Chinese medicine for anti-tumor indications, or minor surgery; and recovery of treatment-induced AEs to grade ≤ 1 (CTCAE v5.0, except for alopecia);
  • Subjects who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) collected from sites not receiving radiotherapy during the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens shall also be provided.
  • Adequate organ functions as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product (no blood transfusions or treatment with granulocyte colony-stimulating factor within 14 days prior to the first administration).
  • For patients with hepatocellular carcinoma, Child-Pugh score must be A;
  • Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months (at least 8 months for Japanese subjects) after the last administration of the investigational product; female subjects of childbearing age must have a negative pregnancy test within 7 days prior to enrollment.

Who cannot join

  • Subjects who meet any of the following criteria are not allowed to be enrolled:
  • Patients who have 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;
  • Patients who previously have immune-related adverse events (irAEs) ≥ grade 3 in immunotherapy;
  • Patients who have history of (non-infectious) interstitial lung disease (ILD) requiring steroids, or current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
  • Subjects who are known to have anaphylaxis to protein preparations/monoclonal antibodies or are allergic to any component in the formulation of the investigational product;
  • Patients who have active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;
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  • Subjects who have 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 for 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);
  • 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; Note: Patients with asymptomatic or stable brain metastases, spinal cord compression, or cancerous meningitis as judged by the investigator are allowed to be enrolled;
  • Patients with known active or suspected autoimmune diseases. Those with autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;
  • Patients who have received systemic corticosteroids (prednisone > 10 mg/day or an equivalent dose of a similar drug) or other immunosuppressive agents within 14 days prior to the first administration; Except for the following circumstances: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; those with short-term use of corticosteroids for prophylaxis if a contrast agent is used;
  • Patients who have used potent inhibitors or inducers of CYP2D6 or CYP3A within 2 weeks prior to the first administration;
  • Patients with active tuberculosis;
  • Patients who have history of immunodeficiency, including human immunodeficiency virus (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; Note: Patients who are HBsAg (+) and/or HBcAb (+) must undergo an HBV-DNA test and have a result of < 500 IU/mL, < 2500 copies/mL, or < ULN to be enrolled. Eligible subjects with detectable HBV-DNA must agree to receive anti-hepatitis B virus nucleoside treatment.
  • Patients who are HCV antibody (+) must undergo an HCV-RNA test and have a result < ULN to be enrolled.
  • Subjects with HBV/HCV co-infection shall be excluded (positive for HBsAg or HBcAb and positive for HCV antibody)
  • Patients who have received live vaccines within 28 days prior to the first administration;
  • Pregnant or lactating women (for Japanese subjects, pregnancy includes situations where the investigator believes that the subject may be pregnant, and lactating women can be enrolled in the study if breastfeeding is stopped, but breastfeeding cannot be resumed after receiving the study treatment);
  • 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

14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

14 sites in 3 countries

United States6 sites

  • Dana Farber Cancer Institute (Harvard)

    Boston, Massachusetts, 02215

  • University of Chicago

    Chicago, Illinois, 60637

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

  • MD Anderson Medical Center

    Houston, Texas, 77030

  • Stanford University

    Stanford, California, 94305

  • Georgetown University

    Washington D.C., District of Columbia, 20057

Other trials in United States

Japan6 sites

  • NHO Shikoku Cancer Center

    Matsuyama

  • Okayama University Hospital

    Okayama, 700-8558

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

China2 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Xiangya Hospital Central South University

    Changsha, Hu'nan, 410008

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX43 (Anti-PD-L1 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, tolerability, and pharmacokinetic characteristics of HLX43 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, tolerability , and pharmacokinetic characteristics of HLX43 with escalated doses in the treatment of patients with advanced/metastatic solid tumors.

In the phase Ia of this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX43 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX43.

In phase Ib of this study, The Safety Review Committee will recommend dose groups for expansion based on the safety, efficacy and PK data of the dose escalation phase. The dose expansion part will include 4 cohorts: advanced/metastatic non-small cell lung cancer (NSCLC) patients with prior failed standard treatment or no standard treatment available, advanced/metastatic thymic carcinoma (TC) patients with prior failed first line platinum based standard treatment, advanced/metastatic NSCLC patients with prior failed standard treatment and docetaxel treatment, and stage IIIB, IIIC, or IV NSCLC patients who have not received any prior treatment with positive PD-L1 expression and no EGFR sensitizing mutation or ALK/ROS gene rearrangement.

Being tested
HLX43, HLX10

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX43Drug

    Also called Anti-PD-L1 ADC

    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).

  • HLX10Drug

    Also called Serplulimab

    All participants will receive serplulimab (300 mg Q3W) via intravenous infusion (IV) until PD without clinical benefits, initiation of new anti-tumor therapy, death, intolerable toxicity, or withdrawal of informed consent (whichever occurs first), and serplulimab will be administered for up to 2 years (35 dosing cycles).

Study groups in NCT06115642
Study groupRoleWhat they receive
Ia (Dose Escalation)ExperimentalPatients with advanced/metastatic solid tumors
Receives: Drug: HLX43
NSCLC failed to standard treatment (Part 2 Dose Expansion)ExperimentalPatients with advanced/metastatic NSCLC, who are refractory to standard treatment, or for which no standard treatment is available.
Receives: Drug: HLX43
Thymic carcinoma (Part 2 Dose Expansion)ExperimentalPatients with advanced/metastatic Thymic carcinoma, who are refractory to first line platinum based standard treatment.
Receives: Drug: HLX43
NSCLC failed to standard and docetaxel treatment (Part 2 Dose Expansion)ExperimentalPatients with advanced/metastatic NSCLC, who are refractory to standard treatment and docetaxel.
Receives: Drug: HLX43
Stage IIIB, IIIC, or IV NSCLC without any prior treatment (Part 2 Dose Expansion)ExperimentalPatients 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.
Receives: Drug: HLX43; Drug: HLX10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Dose-Limiting Toxicity (DLT) of HLX43 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 HLX43.

    Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks)

  2. 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

  3. The maximum tolerated dose (MTD) of HLX43

    The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX43

    Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks)

  4. RP2D

    The recommended phase 2 dose of HLX43

    Measured: approximately up to 24 months

Secondary outcomes (9)

  1. Duration of response (DOR)

    Length of time response continued based on investigator's assessment.

    Measured: approximately up to 24 months.

  2. 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

  3. Overall survival (OS)

    Time from the date of enrollment to the date of death for any cause.

    Measured: approximately up to 24 months

  4. Cmax

    Maximum serum concentration (Cmax) of HLX43.

    Measured: Up to 21 days after the first dose

  5. Tmax

    Time to maximum serum concentration (Tmax) of HLX43.

    Measured: Up to 21 days after the first dose

  6. T1/2

    Half-life (T1/2) of HLX43.

    Measured: Up to 21 days after the first dose

  7. ADA (anti-drug antibody)

    Incidence and titer of ADA of HLX43.

    Measured: approximately up to 24 months

  8. Nab (neutralizing antibody)

    Incidence and titer of Nab of HLX43.

    Measured: approximately up to 24 months

  9. 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.

  1. First posted3 Nov 2023
  2. Study start24 Nov 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
367 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115642
Sponsor's protocol ID
HLX43-FIH101
Status last verified
May 2026
First submitted
30 Oct 2023
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX43 and HLX10 in people with Advanced/Metastatic Malignant Solid Tumors, run by Shanghai Henlius Biotech at 14 sites in 3 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 19 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: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Japan, 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Dose-Limiting Toxicity (DLT) of HLX43 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 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?

On the ClinicalTrials.gov record for NCT06115642.

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 13 Oct 2026.

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