HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
HS-20093 for injection
DrugIntravenous (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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: HS-20093Experimental treatment 1 intervention
Trial outcomes
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\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]
Time frame
From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.Secondary outcomes
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
Time frame
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
Time frame
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).
Time frame
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.
Time frame
From the first dose until 90 days after the last doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov