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Solid Tumor and LymphomaPhase 1/2NCT07333469

A Clinical Study of HX111 in Patients With Advanced Solid Tumor and Lymphoma

A Phase 1/2 study testing HX111 for injection in people with Solid Tumor and Lymphoma, run by Hanx Biopharmaceuticals (Wuhan) Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The study will consist of a Phase I dose-escalation and Phase IIa dose-expansion component. Phase I dose-escalation phase will establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D),and evaluate the preliminary antitumor activity of HX111. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Solid Tumor and Lymphoma
What is being tested?
HX111 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
19 Jan 2026to 19 Jan 2030
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Able to understand and voluntarily sign the Informed Consent Form (ICF); 2. Male or female subject aged 18 to 70 years, inclusive. 3. Eastern Cooperative Oncology Group performance status of 0 to 1. 4. Life expectancy of ≥3 months; 5. Histologically confirmed advanced solid tumors (including sarcomas, head and neck squamous carcinoma, cervical cancer, breast cancer, etc.,) or advanced lymphomas (including peripheral T-cell lymphoma-not otherwise specified, Angioimmunoblastic T-cell Lymphoma, Extranodal Natural Killer/T-cell Lymphoma (nasal type), adult T-cell lymphoma/leukemia, Anaplastic Large Cell Lymphoma, and other EBV+ lymphomas) that is refractory/relapsed to standard therapies, or for which no effective standard therapy , or or for which the subject refuses standard treatment is available,.
  • 6. For advanced solid tumors At least one measurable lesion per RECIST v1.1; 7. For patients with lymphoma:
  • Lymphoma diagnosed according to the 2022 WHO Classification, 5th Edition, and meeting the definition of relapsed/refractory disease.
  • At least one measurable lesion according to the Lugano criteria within 4 weeks prior to the first dose; Measurable lesion: Lymph node with the longest diameter >15 mm, extranodal lesions >10 mm; Lesions previously treated with radiotherapy or other local therapies are considered measurable if disease progression has been documented and they meet the definition of measurable lesions.
  • Able to understand and voluntarily sign the Informed Consent Form (ICF);
  • Male or female subject aged 18 to 70 years, inclusive.
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  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Life expectancy of ≥3 months;
  • Histologically confirmed advanced solid tumors (including sarcomas, head and neck squamous carcinoma, cervical cancer, breast cancer, etc.,) or advanced lymphomas (including peripheral T-cell lymphoma-not otherwise specified, Angioimmunoblastic T-cell Lymphoma, Extranodal Natural Killer/T-cell Lymphoma (nasal type), adult T-cell lymphoma/leukemia, Anaplastic Large Cell Lymphoma, and other EBV+ lymphomas) that is refractory/relapsed to standard therapies, or for which no effective standard therapy , or or for which the subject refuses standard treatment is available,.
  • For advanced solid tumors At least one measurable lesion per RECIST v1.1;
  • For patients with lymphoma:
  • Lymphoma diagnosed according to the 2022 WHO Classification, 5th Edition, and meeting the definition of relapsed/refractory disease.
  • At least one measurable lesion according to the Lugano criteria within 4 weeks prior to the first dose; Measurable lesion: Lymph node with the longest diameter >15 mm, extranodal lesions >10 mm; Lesions previously treated with radiotherapy or other local therapies are considered measurable if disease progression has been documented and they meet the definition of measurable lesions.
  • Adequate organ function, as indicated by the following laboratory values, within 7 days before first dose (unless specified):
  • Hematology (use of hematopoietic growth factors and transfusions not allowed within 14 days prior to the start of the first study treatment) • Absolute neutrophil count (ANC) ≥1.5 × 109/L; for those with bone marrow involvement, ANC ≥1.0 × 109/L Solid tumor
  • Hemoglobin ≥100 g/L
  • Platelet count ≥100 × 109/L lymphoma
  • Hemoglobin (HB) ≥90 g/L; for those with bone marrow involvement, HB ≥80 g/L;
  • Platelet count ≥75×109/L (without bone marrow involvement), platelet count ≥50.0×109/L (with bone marrow or splenic involvement)； Hepatic：
  • Serum total bilirubin ≤1.5×upper limit of normal (ULN); or for patients with total bilirubin levels >1.5ULN but direct bilirubin ≤ULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for subjects with liver metastases, ALT and AST ≤5×ULN) Renal：
  • Serum creatinine ≤1.5×ULN Coagulation function ( within 14 days before first dose)：
  • Prothrombin time/International Normalized Ratio ≤1.5×ULN or activated partial thromboplastin time ≤1.5×ULN (for subjects receiving anticoagulants, the prothrombin time or activated partial thromboplastin time must be within the normal range for their anticoagulant regimen)。 Echocardiogram ( within 28 days before first dose)：
  • LVEF≥50%
  • Male subjects: Must agree to use the contraception methods recommended in Appendix 5 during the treatment period and for at least 12 months after the last dose of the study treatment.
  • Female subjects: Contraception; or not having reproductive potential as defined in Appendix 5; or if of reproductive potential, must agree to use effective contraception during the study treatment period and for at least 12 months after the last dose of study treatment. Female subjects of reproductive potential are required to have a negative pregnancy test within 14 days before administration of the study drug.

Who cannot join

  • 1. Prior malignancy active within the previous 2 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
  • Known allergic reactions to prior recombinant humanized anti-OX40 monoclonal antibody drugs or their components.
  • 2. Received any anti-tumor treatment (chemotherapy, radiotherapy, study drugs including small molecule inhibitors, endocrine therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives of that treatment (whichever is shorter) prior to the first dose of study treatment .
  • 3. Received any investigational anti-tumor treatment within 4 weeks prior to the first dose of study treatment 4. History of Grade ≥2 peripheral neuropathy 5. Toxicities from prior anti-tumor treatments have resolved to ≤Grade 1 or to baseline, with the exception of alopecia and Grade 2 hypothyroidism that can be managed with hormone replacement therapy.
  • 6. Any subject known to be positive for human immunodeficiency virus, or active hepatitis B virus or hepatitis C virus infection.
  • 7. Female subject who is pregnant or lactating. 8. Subjects with a history of or presently experiencing an active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.) within 2 years of initiating study drug, or those who are at high risk of relapse (e.g., receiving an immunosuppressive treatment for an organ transplant); however, subjects with the following are allowed to enroll:
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  • Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic
  • Only requiring hormone replacement therapy for autoimmune hypothyroidism
  • Skin disease that does not require systemic treatment such as eczema, rash that accounts for <10% of the body surface, psoriasis without ophthalmic symptoms.
  • 9. Subjects who have undergone any major surgery (excluding diagnostic surgery) within 4 weeks prior to the first study treatment, and/or subjects who may require major surgery during the study period including the screening period.

About this study

Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of HX111 in Patients With Advanced Solid Tumor and Lymphoma

The study will consist of a Phase I dose-escalation and Phase IIa dose-expansion component. Phase I dose-escalation phase will establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D),and evaluate the preliminary antitumor activity of HX111.

Read the detailed description

Phase I dose-escalation phase Eligible patients with advanced solid tumors and lymphoma will be enrolled. The total sample size is up to 54 patients enrolled for DLT evaluable population. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment (Day 1) until 21 days later (Day 22).

The dose escalation will be guided by Bayesian optimal interval (BOIN) design. The target toxicity rate ϕ is 0.3, The alternative hypothesis toxicity rates are ϕ_1=0.6ϕ and ϕ_2=1.4ϕ, respectively. The posterior probability threshold for dose elimination is 0.95. The maximum number of evaluable subjects per dose group is 9. Dose escalation will continue until one of the following criteria is met

Being tested
HX111 for injection
Keywords
Phase I/IIa
Medical subject headings
Lymphoma

What participants receive

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

  • HX111 for injectionDrug

    HX111, 0.5-2.5mg/kg, once every 3 weeks

Study groups in NCT07333469
Study groupRoleWhat they receive
Intervention armExperimentalHX111 for injection
Receives: Drug: HX111 for injection

What is being measured

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

  1. DLTs

    rate of DLTs

    Measured: 21 days

Secondary outcomes (1)

  1. ORR

    rate of response

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start19 Jan 2026 (estimated)
  3. Primary completion19 Jan 2028 (estimated)
  4. Study completion19 Jan 2030 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study will consist of a Phase I dose-escalation and Phase IIa dose-expansion component. Phase I dose-escalation phase will establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D),and evaluate the preliminary antitumor activity of HX111. Phase I dose-escalation phase Eligible patients with advanced solid tumors and lymphoma will be enrolled. The total sample size is up to 54 patients enrolled for DLT evaluable population. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment (Day 1) until 21 days later (Day 22).
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07333469
Sponsor's protocol ID
HX111-I-01
Status last verified
Jan 2026
First submitted
30 Dec 2025
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HX111 for injection in people with Solid Tumor and Lymphoma, run by Hanx Biopharmaceuticals (Wuhan) Co., Ltd..

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 26 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

DLTs (time frame: 21 days). 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 NCT07333469.

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 Jan 2026.

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