A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05425472
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 9

Study Details

Study Description

Brief Summary

To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Advanced Esophageal Cancer	Drug: HR070803	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: HR070803 for all enrolled subjectsHR070803 for all enrolled subjects
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
• Anticipated Study Start Date: Jun 30, 2022
• Anticipated Primary Completion Date: Jan 30, 2023
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HR070803 HR070803 monotherapy will be administered by intravenous infusion	Drug: HR070803; HR070803

Outcome Measures

Primary Outcome Measures

1. Objective response rate [for 4 months following the date the last patient was randomized]

   The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.

Secondary Outcome Measures

1. Progression Free Survival [for 4 months following the date the last patient was randomized]

   The study is designed to evaluate the progression free survival of HR070803 in patients with advanced esophageal cancer. PFS is defined as the time from first medication to disease progression or death, whichever is earlier

2. Disease Control Rate [for 4 months following the date the last patient was randomized]

   The study is designed to evaluate the disease control rate of HR070803 in patients with advanced esophageal cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD)

3. Duration of Response [for 4 months following the date the last patient was randomized]

   The study is designed to evaluate the duration of response of HR070803 in patients with advanced esophageal cancer. DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.

4. Overall Survival [for 6 months following the date the last patient was randomized]

   The study is designed to evaluate the overall survival of HR070803 in patients with advanced esophageal cancer. OS is defined as the time from first medication to death of any cause, censored for patients alive at data cut-off.

5. Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0 [for 6 months following the date the last patient was randomized]

   Safety and tolerability will consist of monitoring and recording all AEs and SAEs as characterized by type, incidence, severity, and the relationship to the study therapy. AEs will be evaluated for all treated patients using NCI-CTCAE V5.0.

6. ECOG Score for performance status [for 6 months following the date the last patient was randomized]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. ECOG performance status 0 or 1

2. Histologically confirmed advanced esophageal carcinoma

3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)

4. Able and willing to provide a written informed consent

Exclusion Criteria:

1. The tumor obviously invades adjacent organs of esophageal lesions

2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening

3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment

4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05425472
• Other Study ID Numbers: HR070803-201
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Jun 21, 2022