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NCT05277168 · ClinicalTrials.gov registry record · Phase 1

A Trial TO Evaluate THE Safety, Tolerability, Pharmacokinetics, AND Efficacy OF Shr-a1904 IN Subjects With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors, sponsored by Jiangsu HengRui Medicine Co..

Recruiting
Registry status
Phase 1
Development phase
83
Enrollment target
20
Study locations

NCT05277168: Recruiting Phase 1 study of Advanced Solid Tumors, sponsored by Jiangsu HengRui Medicine Co..

NCT05277168 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by Jiangsu HengRui Medicine Co.. The registered enrollment target is 83 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05277168, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by Jiangsu HengRui Medicine Co..

RECRUITING
Registry status
Phase 1
Development phase
83 participants
Enrollment target
20
Study locations

Study Summary

The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.

Primary Outcome

DLT is defined during the first cycle of the study treatment and assessed as certainly or at least possibly related to SHR-A1904 treatment.

Conditions Studied

Interventions

  • DRUG SHR-A1904

Study Locations (20)

New South Wales

  • Central Coast Local Health District - Gosford
  • Sydney South West Private Hospital - Liverpool
  • Scientia Clinical Research Ltd - Randwick
  • Genesis Care North Shore - St Leonards
  • Macquarie University - Sydney
  • Westmead Hospital - Westmead

Other

  • National Institute of Oncology, Arensia Research Clinic - Chisinau
  • Dong-A University Hospital - Busan
  • Chungbuk National University Hospital - Cheongju-si
  • Ajou University Hospital - Gyeonggi-do

Florida

  • Mount Sinai Comprehensive Cancer Center - Miami Beach
  • Comprehensive Hematology Oncology - St. Petersburg

Louisiana

  • LSU Health Sciences Center - New Orleans

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland

Rhode Island

  • Rhode Island Hospital - Providence

South Carolina

  • Prisma Health - Greenville

Texas

  • The University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2022-05-30
Est. Completion 2026-05-30
Phase Phase 1
Jiangsu HengRui Medicine Co.

8 total trials

What NCT05277168 shows while recruiting

NCT05277168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (58% lower).

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which SHR-A1904 is the first listed.

NCT05277168 names 20 study sites across 11 states, led by New South Wales, Other, Florida.

Frequently Asked Questions

What is clinical trial NCT05277168 about?

NCT05277168 is a clinical study titled "A Trial TO Evaluate THE Safety, Tolerability, Pharmacokinetics, AND Efficacy OF Shr-a1904 IN Subjects With Advanced Solid Tumors". The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK)...

What is the current status of trial NCT05277168?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2022-05-30. Estimated completion is 2026-05-30.

What conditions does trial NCT05277168 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT05277168?

The interventions under investigation include: SHR-A1904 (DRUG).

Who is sponsoring clinical trial NCT05277168?

This trial is sponsored by Jiangsu HengRui Medicine Co., which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05277168 being conducted?

This trial has 20 study locations across Florida, Louisiana, Ohio, Rhode Island, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05277168's enrollment target sits among peer trials

83 88th of 144 higher than 57 of 144 other Advanced Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05277168, the US trial registry maintained by the National Library of Medicine. NCT05277168 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.