Clinical trials

34

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Condition / disease
Location
Status: Not yet recruiting

PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC

This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Participants needed: 396
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Jun 12, 2026
Eligibility criteria

Locally advanced or metastastic NSCLC; [+7]

Insufficient wash out duration of prior systemic anticancer therapy [+16]

Status: Recruiting

A Phase I Study of HS-20108 in Participants With Advanced Solid Tumors

This is a Phase I clinical study of HS-20108. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors.

Participants needed: 502
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Jun 2, 2026Locations: 1
Eligibility criteria

Men or women aged more than or equal to (≥) 18 years. [+8]

Inadequate bone marrow reserve or serious organ dysfunction. [+9]

Status: Not yet recruiting

A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.

Participants needed: 494
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Jun 2, 2026
Eligibility criteria

Age ≥18 years at the time of informed consent form (ICF) signature, either sex. [+8]

Prior or current treatment targeting B7-H3; [+1]

Status: Recruiting

A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.

This is a multicenter, open-label Phase Ib/II clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. "Rolling 6" design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.

Participants needed: 502
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: May 1, 2026Locations: 1
Eligibility criteria

Males or females, aged ≥ 18 years. [+3]

Anti-tumor drugs within 14 days prior to the first dose of study treatment; any... [+9]

Status: Recruiting

A Study of HS-20110 in Participants With Advanced Solid Tumors

This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors

Participants needed: 475
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Apr 20, 2026Locations: 8
Eligibility criteria

Males or females, aged ≥ 18 years. [+2]

Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal... [+10]

Status: Not yet recruiting

A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.

Participants needed: 450
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Mar 11, 2026
Eligibility criteria

Age ≥18 years at the time of informed consent form (ICF) signature, either sex. [+8]

Prior pathological diagnosis of mixed non-small cell lung cancer or any transfor... [+17]

Status: Recruiting

HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 1b, open-label, multi-center study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HS-20093 in patients with advanced gastric and gastroesophageal junction adenocarcinoma.

Participants needed: 40
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

At least age of 18 years at screening, with no restrictions on gender. [+9]

Previous or current treatment with B7-H3 targeted therapy. [+32]

Status: Recruiting

Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors

The primary objective of this study is to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors.

Participants needed: 18
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

Histologically or cytologically confirmed advanced solid tumors that have failed... [+3]

Patients with a contraindication for receiving itraconazole according to the pre... [+1]

Status: Recruiting

A Study of HS-20122 in Patients With Advanced Solid Tumors

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.

Participants needed: 1,050
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

Males or females, aged ≥ 18 years. [+8]

Any unresolved toxicities from prior therapy greater than Grade 2 according to C... [+36]

Status: Recruiting

HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Participants needed: 468
Trial details
Phase: Phase 3Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Dec 17, 2025Locations: 1
Eligibility criteria

Voluntary participation and written informed consent. [+9]

Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload. [+7]

Status: Recruiting

Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors. This is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.

Participants needed: 63
Trial details
Phase: Phase 1Age: 18+Biological sex: MaleType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Dec 5, 2025Locations: 1
Eligibility criteria

Men greater than or equal to 18 years. [+5]

Any unresolved toxicities from prior therapy greater than Grade 2 according to C... [+11]

Status: Recruiting

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

Participants needed: 1,080
Trial details
Phase: Phase 2, Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Aug 1, 2025Locations: 2
Eligibility criteria

Males or females aged 18 - 75 years (inclusive). [+8]

Previous or current treatment with MET targeted therapy or EGFR targeted antibod... [+19]

Status: Not yet recruiting

A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.

Participants needed: 305
Trial details
Phase: Phase 2Age: 18-70Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Apr 13, 2025Locations: 1
Eligibility criteria

Male or female subjects between the ages of 18-70 years [+3]

Diagnosis of non-plaque psoriasis or drug-induced psoriasis [+8]

Status: Recruiting

Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.

Participants needed: 780
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Apr 9, 2025Locations: 1
Eligibility criteria

Males or females aged 18 - 75 years (inclusive). [+7]

Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-dru... [+11]

Status: Not yet recruiting

A Study of HS-20137 in Participants with Moderate-to-severe Plaque Psoriasis

The primary objective of this study is to evaluate the efficacy and safety of HS-20137 in the treatment of participants with moderate to severe plaque psoriasis.

Participants needed: 720
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Feb 25, 2025
Eligibility criteria

Adults aged 18 and above, male or female; [+4]

Previous use of biological agents, or allergic reactions to known drug ingredien... [+8]

Status: Recruiting

ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents in patients with advanced metastatic colorectal cancer.

Participants needed: 560
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Feb 13, 2025Locations: 1
Eligibility criteria

At least age of 18 years at screening. [+9]

Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisome... [+28]

Status: Recruiting

A Study of HS-20124 in Patients with Advanced Solid Tumors

HS-20124 is a novel DAR-8 antibody-drug conjugate (ADC) targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.

Participants needed: 450
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Jan 8, 2025Locations: 1
Eligibility criteria

At least age of 18 years at screening; [+7]

Previous or current treatment with CDH6 targeted therapy [+4]

Status: Recruiting

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors

HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety, pharmacokinetics and immunogenicity of HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.

Participants needed: 220
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Dec 2, 2024Locations: 21
Eligibility criteria

Men or women aged more than or equal to (≥) 18 years. [+9]

Subjects with previous or concurrent malignancies [+13]

Status: Not yet recruiting

ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on bone and soft tissue sarcoma. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced bone and soft tissue sarcoma.

Participants needed: 448
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Nov 21, 2024
Eligibility criteria

At least age of 18 years at screening; [+11]

Previous or current treatment with B7-H3 targeted therapy [+19]

Status: Not yet recruiting

A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.

Participants needed: 375
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Nov 4, 2024Locations: 1
Eligibility criteria

Male or female subjects aged 18 years and older [+4]

Diagnosis of non-plaque psoriasis or drug-induced psoriasis [+8]

Status: Recruiting

ARTEMIS-008:HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer

The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).

Participants needed: 460
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Oct 16, 2024Locations: 9
Eligibility criteria

Male or female subjects ≥18 years of age. [+8]

Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has trans... [+24]

Status: Not yet recruiting

A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy

This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.

Participants needed: 90
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Oct 10, 2024Locations: 1
Eligibility criteria

Male or female, between 18 and 65 years age. [+5]

IgA nephropathy secondary to another condition [+9]

Status: Recruiting

A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.

Participants needed: 84
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Oct 9, 2024Locations: 1
Eligibility criteria

Healthy male or female subjects between the ages of 18-45 years [+2]

History or evidence of clinically significant cardiovascular, pulmonary, endocri... [+6]

Status: Not yet recruiting

A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.

Participants needed: 176
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

Diagnosis of MDS according to World Health Organization (WHO) classification tha... [+3]

Chromosome 5q deletion, del (5q). [+3]

Status: Recruiting

HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer

HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20089 as monotherapy in patients with recurrent or metastatic ovarian cancer and endometrial cancer.

Participants needed: 460
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Hansoh BioMedical R&D CompanyUpdated: Aug 29, 2024Locations: 28
Eligibility criteria

Males or females aged 18 years or older (≥18 years). [+8]

B7-H4-targeted therapies. [+32]