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This trial was terminated voluntarily by the Sponsor for reasons related to its corporate strategic development, with no safety concerns or efficacy signals related to the investigational product identified.
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This study is an open-label Phase 1, First in Human trial of DR30303, a recombinant humanized monoclonal antibody that targets Claudin18.2 (CLDN18.2). It is composed of humanized variable domain of heavy chain of antibody (VHH) fused with engineered immunoglobulin gamma-1(IgG1) Fc. It is being testing against advanced and/or metastatic solid tumors.
This study is an open, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of DR30303 in patients with advanced solid tumors. The study is composed of two parts: part 1 is Dose escalation stage and part 2 is Dose expansion stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DR30303 | Experimental | DR30303 injection treatment. This phase 1 trial will include two stages, a dose escalation stage and an expansion stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR30303 | Drug | DR30303 dose level of escalation IV every 3 weeks (Q3W) Day 1, as well as dose expansion with recommended dose level from dose escalation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1：Incidence of dose limiting toxicities (DLTs) | up to 21 days following first dose | |
| Part 1：Number, severity and duration of treatment-emergent adverse events (TEAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | up to 28 days following last dose | |
| Part 1：Maximum Tolerated Dose (MTD) and/or Biological effective dose (BED) based on safety, tolerability, PK profile and preliminary efficacy data | from date of last dose until the date of will receive DR30303 for 1 year or last documented progression，whichever occurs first | |
| Part 2: Recommended Phase 2 Dose (RP2D) based on safety, tolerability, PK profile, and preliminary efficacy data | from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first | |
| Part 2: Number, severity and duration of treatment-emergent adverse events (TEAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | up to 28 days following last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | These measure are defined as the proportion of subjects with complete response (CR) or partial response (PR) | from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongming Pan, MD,PhD | Sir Run Run Shaw Hospital | Principal Investigator |
| Yanshan Huang, PhD | Zhejiang Doer Biologics Co., Ltd. | Study Chair |
| Junfang Xu, MD | Huadong Medicine Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital，Zhejiang University School of Medicine | Hanzhou | Zhejiang | 311100 | China |
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| Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | These measure are defined as the proportion of subjects with CR, PR and stable disease (SD) | from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first |
| Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | These measure are defined as the duration from the first occurrence of confirmed CR or PR until the date of disease progression or death (from any cause) | from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first |
| Clinical Benefit Rate | Defined as Proportion of subjects with CR, PR and duration of SD ≥ 12 weeks | from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first |
| Duration of disease control (DDC) per RECIST v1.1 | For subjects with CR, PR, or SD, duration was calculated from the first assessment as CR, PR, or SD until the date of disease progression or death (from any cause) | from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first |
| Progression free survival (PFS) per RECIST v1.1 | These measure are defined as time from start of treatment to tumor progression or death from any cause | from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first |
| 6-month and 12-month survival rates | from date of first dose start until the date of first documented progression , 6 months，12 months whichever came first |
| Overall survival (OS) per RECIST v1.1 | These measure are defined as time from start of treatment to death from any cause | from date of first dose start until the date of first documented progression or death from any cause，or the date of will receive DR30303 for 1 year whichever came first |
| Pharmacokinetic (PK) of DR30303: Maximum serum concentration (Cmax) | up to 28 days following last dose |
| PK of DR30303: Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) | up to 28 days following last dose |
| PK of DR30303: Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) | up to 28 days following last dose |
| PK of DR30303: Time of the maximum concentration (tmax) | up to 28 days following last dose |
| PK of DR30303: Terminal elimination half-life (t1/2) | up to 28 days following last dose |
| Immunogenicity by measurement of Incidence of anti-drug antibodies (ADA) | up to 28 days following last dose |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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