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Trial Title:
Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
NCT ID:
NCT05533463
Condition:
Advanced KRAS G12D Mutant Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single arm study of HRS-4642
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-4642
Description:
HRS-4642 will be administrated per dose level in which the patients are assigned.
Arm group label:
HRS-4642
Summary:
The study is being conducted to evaluate the safety and tolerability of HRS-4642 in
patients with advanced solid tumors harboring KRAS G12D mutation.To estimate the maximum
tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose
[RP2D]) within investigated subject population groups
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must voluntarily agree to participate in the trial and sign a written
informed consent form.
2. Male or female ≥ 18 years old.
3. Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D
mutation
4. ECOG performance status of 0-1.
5. With a life expectancy of ≥3 months.
6. Have at least one measurable lesion.
7. Adequate laboratory parameters during the screening period
Exclusion Criteria:
1. Previously received KRAS G12D inhibitors
2. Priot radiotherapy within 28 days for non-thoracic radiation
3. Prior anti-tumor chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or
mitomycin) within 4 weeks before the study drug administration
4. Any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1
or inclusion/exclusion criteria level (The investigators determined that safe and
controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral
neuropathy ).
5. Central nervous system (CNS) metastases
6. Major surgical therapy within 28 days prior to the date of signature of informed
consent form, or expected major surgery during the study.
7. Known history of hypersensitivity to any components of HRS-4642.
8. Other factors that may affect the study results or lead to forced termination of the
study early as judged by investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
ShangHai
Zip:
200433
Country:
China
Status:
Recruiting
Investigator:
Last name:
Caicun Zhou
Email:
Principal Investigator
Start date:
September 15, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05533463
