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Recruiting NCT07134998

Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

Phase I Interventional Advanced KRAS G12D Mutant Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-6093.
Who it may be relevant to
Registry conditions: Advanced KRAS G12D Mutant Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study of HRS-6093 Evaluating Safety, Tolerability, and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

Overview

This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.

Interventions

  • Drug HRS-6093
    HRS-6093

Primary outcome measures

  • Incidence and severity of adverse events/serious adverse events (graded as per CTCAE v5.0). [Time frame: Screening Period to 30 Days After the Last Dose]
  • DLT, [Time frame: from day1 to day 23; 23 Days]
  • MTD, [Time frame: from day1 to day 23; 23 Days]
  • RP2D , [Time frame: 24 months]
Secondary outcome measures (12)
  • Number of Participants With Abnormal Laboratory Values [Time frame: Screening Period to 30 Days After the Last Dose; 24 months]
  • Number of subjects with clinically significant changes in ECOG, vital signs and physical examination. [Time frame: Screening Period to 30 Days After the Last Dose; 24 months]
  • Number of subjects with changes on ECG. [Time frame: Screening Period to 30 Days After the Last Dose; 24 months]
  • maximum plasma concentration (Cmax), [Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months]
  • time to maximum concentration (Tmax), [Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months]
  • area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t), [Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months]
  • Area under concentration-time curve from time 0 to infinity (AUC 0-∞), apparent volume of distribution (Vz/F), [Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months]
  • elimination half-life (t1/2), and apparent clearance (CL/F); [Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months]
  • minimum concentration at steady state (Cmin, ss), [Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months]
  • area under the blood concentration-time curve at steady state (AUCss), and accumulation ratio (Rac); [Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months]
  • objective response rate (ORR), [Time frame: Screening Period to PD; 24 months]
  • duration of response (DoR), [Time frame: Screening Period to PD; 24 months]

Eligibility criteria

Inclusion criteria

  • Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
  • Aged between 18-75 years, with no gender requirement;
  • Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment, are intolerant to standard treatment, or have not received standard treatment.
  • ECOG performance status (PS) score of 0 or 1;
  • Life expectancy > 3 months;
  • At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided.
  • Adequate organ function

Exclusion criteria

  • Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/exclusion criteria;
  • Presence of central nervous system (CNS) metastases;
  • Participants with gastrointestinal diseases that affect drug administration/absorption
  • Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period;
  • Presence of serious pulmonary diseases
  • Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
  • Active or persistent gastrointestinal bleeding within 6 months prior to screening;
  • History of allogeneic bone marrow or solid organ transplantation;
  • History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
  • Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);
  • Known history of hypersensitivity to any component of the drug product to be used in the study;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Shanghai Jiao Tong University School of Medicine — Shanghai
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT07134998 · HRS-6093-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗