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A Clinical Study of HX111 in Patients With Advanced Solid Tumor and Lymphoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

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

NCT07333469•Hanx Biopharmaceuticals (Wuhan) Co., Ltd.

View on ClinicalTrials.gov

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.

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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;
+16 more criteria

Exclusion Criteria

•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:
•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.

Key Dates

Start Date

January 19, 2026

Primary Completion Date

January 19, 2028

Completion Date

January 19, 2030

Last Updated

January 13, 2026

Enrollment

ESTIMATED participants

Conditions

Solid Tumor and Lymphoma

Interventions

HX111 for injection

DRUG

A Phase I Study to Investigate the Safety, Tolerability and PK of HLX60 (Anti-GARP Monoclonal Antibody) in Subjects With Solid Tumors or Lymphoma

NCT05606380

Solid Tumor and Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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