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Advanced Gastric and Gastroesophageal Junction AdenocarcinomaPhase 1NCT07462923

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

A Phase 1 study testing HS-20093 for injection in people with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma, run by Hansoh BioMedical R&D Company at 12 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HS-20093 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
12 sitesChina
Study dates
29 Jan 2026to 31 Mar 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least age of 18 years at screening, with no restrictions on gender.
  • Signed and dated Informed Consent Form.
  • Participants with pathologically or cytologically confirmed locally advanced unresectable or metastatic GC/GEJC, who have failed, or intolerant to standard therapies.
  • At least one extra measurable lesion according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
  • Estimated life expectancy >12 weeks.
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  • Agree to provide fresh or archival tumor tissue.
  • Good organ function.
  • Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.
  • Men or women should be using adequate contraceptive measures throughout the study.

Who cannot join

  • Treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy.
  • Previous or current treatment with topoisomerase I inhibitors.
  • 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
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  • Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
  • Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
  • Histology shows squamous cell carcinoma, undifferentiated carcinoma, or mixed tumors , such as adenosquamous carcinoma or other mixed tumors.
  • Any unresolved toxicities from prior therapy greater than Grade 1 according to CTCAE 5.0 or baseline status.
  • Presence of pleural effusion/ascites requiring clinical intervention.
  • Newly diagnosed brain metastases without treatment, or brain metastases that have not achieved stability despite treatment; presence of leptomeningeal metastasis or brainstem metastasis; presence of spinal cord compression.
  • History of other primary malignancies
  • Evidence of cardiovascular risk.
  • Severe, uncontrolled or active cardiovascular diseases.
  • Severe or poorly controlled hypertension.
  • Severe or poorly controlled diabetes.
  • Poorly controlled cancer-related pain.
  • The presence of active infectious diseases has been known: hepatitis B, hepatitis C and HIV.
  • Major surgery within 4 weeks prior to the first scheduled dose of HS-20093.
  • Active infection requiring therapeutic intravenous antibiotics within 2 weeks prior to the first dose.
  • Clinically significant bleeding symptoms or marked hemorrhagic tendency within 1 month prior to the first dose of HS-20093.
  • Serious arterial or venous thromboembolic events occurring within 3 months prior to the first dose of HS-20093.
  • Active tuberculosis.
  • History of known interstitial pneumonia or immune-mediated pneumonitis.
  • History of active or prior autoimmune disease requiring systemic treatment.
  • Severe malnutrition.
  • Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.
  • Requires long-term glucocorticoid therapy.
  • Having undergone any major surgery within 4 weeks prior to the first dose.
  • Vaccination within 4 weeks prior to the first dose of HS-20093.
  • History of severe allergy.
  • Previous history of serious neurological or mental disorders. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
  • Currently enrolled in or participating in any other clinical study involving investigational interventions or other types of interventional medical research.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • The First Hospital of China Medical University

    Beijing, Beijing Municipality

  • Hunan Cancer Hospital

    Changsha, Hunan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

  • Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase Ib Clinical Study on the Efficacy, Safety, Tolerability, and Pharmacokinetics of 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.

Read the detailed description

The first approximately 20 eligible participants who meet the inclusion criteria and do not meet the exclusion criteria will receive intravenous infusion of 8.0 mg/kg HS-20093 once every three weeks (Q3W). Treatment will continue until objective disease progression or other treatment discontinuation criteria are met.

Based on preliminary safety, efficacy, and pharmacokinetic data, the sponsor may decide whether subsequent participants will continue the current dosing regimen (8.0 mg/kg, Q3W), switch to a lower dose (e.g., 6.0 mg/kg, Q3W), a higher dose (e.g., 10.0 mg/kg, Q3W), or transition to a dosing frequency of once every two weeks (with a single dose not exceeding 6.0 mg/kg).

Being tested
HS-20093 for injection
Keywords
Gastric and Gastroesophageal Junction Adenocarcinoma, HS-20093

What participants receive

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

  • HS-20093 for injectionDrug

    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 NCT07462923
Study groupRoleWhat they receive
HS-20093ExperimentalParticipants will receive HS-20093
Receives: Drug: HS-20093 for injection

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 or withdrawal from study, whichever came first, assessed up to 24 months.

Secondary outcomes (8)

  1. 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.

  2. Unconfirmed ORR (uORR)

    The proportion of participants who achieve a CR or PR as assessed by the investigator according to the RECIST v1.1 criteria

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

  3. Duration of response (DoR)

    the time from the date of first documented objective response (CR or PR as assessed by the investigator according to the RECIST v1.1 criteria) to the date of first documented PD or death (whichever occurs first).

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

  4. Incidence and severity of adverse events (AEs)

    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

  5. Cmax of HS-20093

    The Cmax is the maximum observed drug concentration of HS-20093

    Measured: At the end of Cycle 1 (each cycle is 21 days)"

  6. Tmax of HS-20093

    The Tmax is defined as time to reach maximum observed drug concentration of HS-20093

    Measured: At the end of Cycle 1 (each cycle is 21 days)"

  7. AUC0-t of HS-20093

    The AUC0-t is defined as the area under the drug concentration-time curve during a dose interval time period(t) of HS-20093

    Measured: At the end of Cycle 1 (each cycle is 21 days)"

  8. Incidence of anti-hs-20093 antibodies (ADAs)

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

    Measured: From the first dose until 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 posted10 Mar 2026
  2. Study start29 Jan 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2028 (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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07462923
Sponsor's protocol ID
HS-20093-109
Status last verified
Oct 2026
First submitted
15 Jan 2026
Last updated
30 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20093 for injection in people with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma, run by Hansoh BioMedical R&D Company at 12 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 34 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: under way, not looking for participants, as of the sponsor's last update on 30 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 12 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 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?

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 or withdrawal from study, whichever came 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 NCT07462923.

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 30 Oct 2026.

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