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Advanced Solid TumorPhase 2NCT06112704

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

A Phase 2 study testing HS-20093 in people with Advanced Solid Tumor, run by Hansoh BioMedical R&D Company at 21 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HS-20093
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
21 sitesChina
Study dates
6 Feb 2024to 31 Dec 2026
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women aged more than or equal to (≥) 18 years.
  • Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
  • At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).
  • Agree to provide fresh or archival tumor tissue and blood samples.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
  • Estimated life expectancy >12 weeks.
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  • Agree to use medically accepted methods of contraception.
  • Men or women should be using adequate contraceptive measures throughout the study.
  • Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
  • Signed and dated Informed Consent Form.

Who cannot join

  • Any of the following would exclude the subject from participation in the study:
  • Treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093
  • Subjects with previous or concurrent malignancies
  • Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula
  • Inadequate bone marrow reserve or organ dysfunction.
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  • Evidence of cardiovascular risk
  • Evidence of current severe or uncontrolled systemic diseases
  • Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
  • Severe infections occured within 4 weeks before the first dose
  • The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect
  • History of neuropathy or mental disorders
  • Pregnant or lactating female
  • History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093
  • Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093
  • Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
  • Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yun Sun contact

18321785381

suny20@hspharm.com

21 sites in 1 country

China21 sites, 21 recruiting

  • Tumour Hospital of Anyang city

    Anyang, Henan, 455000

    Recruiting

  • Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China

    Chengdu, Sichuan, 610041

    Recruiting

  • Fujian Provincial Tumor Hospital

    Fujian, Fujian, 350014

    Not yet recruiting

  • The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

    Fuzhou, Fujian, 350014

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 1540000

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, 471003

    Recruiting

  • Jiangxi Provincial Tumor Hospital

    Nanchang, Jiangxi, 330038

    Not yet recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226300

    Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan, 422000

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

    Recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

    Recruiting

  • Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Not yet recruiting

  • Jiangyin People's Hospital

    Wuxi, Jiangsu, 214400

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

About this study

Official title: A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)

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.

Read the detailed description

This is an open-label, multi-center phase 2 study in Chinese adult participants with recurrent, locally advanced or metastatic esophageal carcinoma or other advanced solid tumors, which is designed to investigate the efficacy, safety, pharmacokinetics and immunogenicity of HS-20093. This study will consist of two parts: phase IIa and phase IIb.

Part 1 (phase IIa) will conducted in participants with relapsed, locally advanced or metastatic esophageal carcinoma and other advanced solid tumor. Subjects will receive one dose levels of HS-20093 intravenously every 3 weeks.

Part 2 (phase IIb) will enroll participants with relapsed, locally advanced or metastatic esophageal squamous cell carcinoma. One dose levels of HS-20093 will be administered as an intravenous (IV) infusion every 3 weeks.

Being tested
HS-20093
Keywords
Advanced solid tumor, Esophageal Carcinoma, B7-H3, antibody-drug conjugate (ADC), HS-20093
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • HS-20093Drug

    Intravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Study groups in NCT06112704
Study groupRoleWhat they receive
Phase IIa: Cohort 1ExperimentalParticipants with advanced esophageal squamous cell carcinoma will be administered HS-20093.
Receives: Drug: HS-20093
Phase IIa: Cohort 2ExperimentalParticipants with advanced esophageal adenocarcinoma and gastroesophageal junction adenocarcinoma will be administered HS-20093.
Receives: Drug: HS-20093
Phase IIa: Cohort 3ExperimentalParticipants with other advanced solid tumor will be administered HS-20093.
Receives: Drug: HS-20093
Phase IIbExperimentalParticipants with advanced esophageal squamous cell carcinoma will be administered HS-20093.
Receives: Drug: HS-20093

What is being measured

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

  1. Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].

    Measured: From the first dose up to disease progression（PD）or withdrawal from study，whichever comes first，assessed up to 24 months.

Secondary outcomes (7)

  1. DOR assessed by RECIST 1.1 criteria

    DOR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)

    Measured: From the first dose up to PD or death, whichever came first, assessed up to 24 months.

  2. Disease Control Rate (DCR) assessed by RECIST 1.1 criteria

    DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose.

    Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months.

  3. PFS assessed by RECIST 1.1 criteria

    PFS was defined as the time from first dose or random assignment (if any) to PD or death from any cause

    Measured: From the first dose up to PD or death，whichever came first, assessed up to 24 months.

  4. Overall survival (OS)

    OS was defined as the time from the first dose or random assignment (if any) to death from any cause

    Measured: From the first dose up to PD or death，whichever came first, assessed up to 24 months.

  5. Incidence and severity of adverse events

    AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc

    Measured: From the first dose until 90 days after the last dose

  6. Characterize the pharmacokinetic parameters of HS-20093

    Characterize the pharmacokinetic parameters of HS-20093

    Measured: Cycle 1 Day 1 up to 90 days after the last dose

  7. Assess the incidence of anti-drug antibodies (ADAs)

    Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points

    Measured: Cycle 1 Day 1 up to 90 days after the 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 posted1 Nov 2023
  2. Study start6 Feb 2024
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112704
Sponsor's protocol ID
HS-20093-203
Status last verified
Nov 2024
First submitted
29 Oct 2023
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS-20093 in people with Advanced Solid Tumor, run by Hansoh BioMedical R&D Company at 21 sites in China.

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 10 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in 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 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?

Contact Yun Sun (18321785381, suny20@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (time frame: From the first dose up to disease progression（PD）or withdrawal from study，whichever comes first，assessed up to 24 months.). 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 NCT06112704.

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 2 Dec 2024.

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