A Study of HS-20089 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hansoh Biomedical Co., Ltd
About this trial
HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 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-20089 in Patients With Advanced Solid Tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women aged more than or equal to (≥) 18 years
Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
Disqualifiers
Previous or current treatment with drugs targeting B7-H4
Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
Radiotherapy with a limited field of radiation 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 of the first dose.
Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
Trial design
Design model
Sequential
Treatments tested in this trial
HS-20089 (Phase Ia：Dose escalation )
DrugParticipants will receive HS-20089 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
HS-20089 (Phase Ib: Dose expansion)
DrugIV administration of HS-20089 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Treatment groups
177 Participants
are divided into 2 treatment groupsGroup A: HS-20089 (Phase Ia：Dose escalation )Experimental treatment 1 intervention
Group B: HS-20089 (Phase Ib: Dose expansion)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose of HS-20089
To determine the MTD for further evaluation of IV administration of HS-20089 in subjects with advanced solid tumors.
Time frame
3 weeks after initiation of treatmentSecondary outcomes
1
Incidence and severity of treatment-emergent adverse events
The CTCAE criteria will be used to assess adverse events on this trial.
Time frame
Baseline through study completion(90 days after last dose)2
Observed maximum plasma concentration (Cmax) after single dose of HS-20089
Cmax will be obtained after single dose of HS-20089 on Day 1.
Time frame
From pre-dose to 120 hours after single dose on Day 13
Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-20089
Cmax ss will be obtained on Day 1 of dosing in the 21-Day cycle of therapy.
Time frame
From pre-dose to 24 hours after the dose on Day 1 of the 21-Day cycle of therapy4
Apparent terminal half-life (t1/2) after single dose of HS-20089
Apparent terminal half-life is the time measured for the concentration to decrease by one half.
Time frame
From pre-dose to 120 hours after single dose on Day 1Sponsors and contacts
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Source ClinicalTrials.gov