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A Study of HR19024 in Subjects With Advanced Solid Tumor

Hengrui Medicine logo

Hengrui Medicine

Status and phase

Enrolling
Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: HR19024

Study type

Interventional

Funder types

Industry

Identifiers

NCT05463432
HR19024-101

Details and patient eligibility

About

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

Enrollment

180 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

180 participants in 1 patient group

HR19024
Experimental group
Description:
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
Treatment:
Drug: HR19024

Trial contacts and locations

1

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Central trial contact

Hao Geng

Data sourced from clinicaltrials.gov

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