Health TrialsbyHealthPanel

GenSci143 in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of GenSci143 in Participants with Advanced Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the ICF.

Male or female participants ≥18 years old at the time of signing the ICF.

Dose escalation: Participants with histologically or cytologically documented recurrent or metastatic advanced solid tumors, and who have progressed after standard therapy, are intolerant to standard therapy, or have no standard therapy available.

Life expectancy of ≥ 12 weeks.

Disqualifiers

Participants with known spinal cord compression or active central nervous system (CNS) metastases, unless they are asymptomatic or have achieved post-treatment stability for >4 weeks and discontinued corticosteroids for >2 weeks before the first dose of GenSci143.

History of other known malignancies within the past 3 years.

Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose of GenSci143.

Uncontrolled or clinically significant cardiovascular disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • GenSci143 for injection

    Drug

    GenSci143 for injection, administered Q3W, with a dosage ranging from 0.5mg/kg to 4.5mg/kg.

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: GenSci143 for injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 and Part2:Incidence of adverse events Percentage of patients with adverse events by system organ class and preferred term.

Time frame
From time of informed consent to 30days post last dose of GenSci143
2

Part1:Dose limiting toxicities(DLTs),DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocal

Time frame
Form time of first dose of GenSci143 to end of DLT observation period(approximately 21 days)
3

Part1: Maximum tolerated dose (MTD) and recommended dose for expansion (RDE) To determine the maximum tolerated dose (MTD) (if applicable) and recommended dose for expansion (RDE) of GenSci143.

Time frame
Form time of first dose of GenSci143 up to 12 months.
4

Part1: Part2: Composite response rate To evaluate the efficacy of GenSci143 as using RECIST v1.1 and/or PSA50 response (PCWG3) with PC

Time frame
Approximately 12 months.

Secondary outcomes

1

AUC of GenSci143 Calculate area under the curve of GenSci143.

Time frame
Approximately 12 months.
2

AUC of total antibody Calculate area under the curve of total antibody.

Time frame
Approximately 12 months

Other outcomes

1

AUC of unconjugated payload. Calculate area under the curve of unconjugated payload

Time frame
Approximately 12 months
2

Cmax of GenSci143 Calculate maximum concentration of GenSci143.

Time frame
Approximately 12 months
3

Cmax of total antibody Calculate maximum concentration of total antibody

Time frame
Approximately 12 months
4

Cmax of unconjugated payload Calculate maximum concentration of unconjugated payload

Time frame
Approximately 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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