A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors

Study Overview
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Brief Summary
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This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.

Official Title
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A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors

Conditions
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Advanced Malignant Cancer

Intervention / Treatment
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* Drug: SHR-1909 injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment; Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin); Adequate organ function. Exclusion Criteria: With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion; Received prior CAR T-cell therapy; Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease; With active infection or fever of unknown origin (> 38.5 °C).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Dose escalation (non randomized， 6 arms); Dose-expansion and efficacy-expansion(non-randomized,1-3 arms)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1909 monotherapy<br> | Drug: SHR-1909 injection<br>* SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD of SHR-1909 | Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs) | From Day 1 to 4 weeks | 
| RP2D of SHR-1909 | Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data. | From Day 1 to 90 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse Events documented by CTCAE 5.0 | 90 days after the last dose | 
| Objective Response Rate (ORR) | Baseline to documented disease progression or study discontinuation | Up to approximately 2 years | 
| Progression-Free Survival (PFS) | From Day 1 to Radiographic Progression or Death Due to Any Cause | Up to approximately 2 years |