A Study of HR19024 in Subjects With Advanced Solid Tumor

Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05463432
Collaborator
(none)
180
1
12

Study Details

Study Description

Brief Summary

To evaluate the safety,tolerability,pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
HR19024 for all enrolled subjectsHR19024 for all enrolled subjects
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection in Subjects With Advanced Solid Tumor
Anticipated Study Start Date :
Jul 30, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HR19024

Part 1: Dose escalation of HR19024 montherapy for advanced solid tumor Part 2:PK expansion of HR19024 montherapy for advanced solid tumor Part 3: Efficacy expansion of HR19024 montherapy for advanced solid tumor

Drug: HR19024
Intravenous infusion

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose (MTD) of HR19024 [21-day cycle (tri-weekly)]

Secondary Outcome Measures

  1. Response rate (RR) [up to 6 months following the date the last patient was randomized]

  2. Disease Control Rate [up to 6 months following the date the last patient was randomized]

  3. Duration of Response [up to 6 months following the date the last patient was randomized]

  4. Progression free survival (PFS) [up to 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 solid tumor

  3. Life expectancy of greater than or equal to (>=) 12 weeks

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

  5. Able and willing to provide a written informed consent

Exclusion Criteria:
  1. Subjects with unresolved toxicity (> CTCAE G1)of prior therapy at the time of enrolment

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Hengrui Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05463432
Other Study ID Numbers:
  • HR19024-101
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 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:

Study Results

No Results Posted as of Jul 19, 2022