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

NCT07462923 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-20093-109
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 gastroesophageal junction adenocarcinoma.

Conditions

Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Keywords

Gastric and Gastroesophageal Junction Adenocarcinoma; HS-20093

Outcome Measures

Primary Outcomes (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\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]

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

Secondary Outcomes (8)

• PFS assessed by RECIST 1.1 criteria

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

• Unconfirmed ORR (uORR)

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

• Duration of response (DoR)

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

• Incidence and severity of adverse events (AEs)

  From the first dose until 90 days after the last dose

• Cmax of HS-20093

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

Study Arms (1)

HS-20093

EXPERIMENTAL

Participants will receive HS-20093

Drug: HS-20093 for injection

Interventions

HS-20093 for injection DRUG

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.

HS-20093

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: March 10, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CN (1)