Trials Sponsors Conditions Drugs Pricing

Conditions

Malignant Neoplasm of Digestive System

Keywords

Malignant neoplasm of digestive system

Outcome Measures

Primary Outcomes (5)

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

Secondary Outcomes (14)

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
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
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
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)
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
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
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

Study Arms (1)

DR30303

EXPERIMENTAL

DR30303 injection treatment. This phase 1 trial will include two stages, a dose escalation stage and an expansion stage.

Drug: DR30303

Interventions

DR30303Drug

DR30303 dose level of escalation IV every 3 weeks (Q3W) Day 1, as well as dose expansion with recommended dose level from dose escalation.

DR30303

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Fully informed of this study and voluntarily sign informed consent form (ICF).
Aged 18 to 75 years, gender is not limited.

Sponsors & Collaborators

Zhejiang Doer Biologics Co., Ltd.
Industrylead

Study Sites (1)

Sir Run Run Shaw Hospital，Zhejiang University School of Medicine

Hanzhou, Zhejiang, 311100, China

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System Diseases

Study Officials

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

Enrollment

13 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 6, 2022

Study Start

May 13, 2022

Actual (reported)

Primary Completion

Study Stopped

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (14)

Study Arms (1)

DR30303

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (14)

Study Arms (1)

DR30303

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations