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Recruiting NCT07142980

A Phase I Study of HRS-7172 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Phase I Interventional Advanced Solid Tumors Harboring RAS Mutations or Amplifications

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-7172 Tablets.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors Harboring RAS Mutations or Amplifications. 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-7172 Evaluating Safety, Tolerability and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Overview

This is a phase I study of HRS-7172 to evaluate safety, tolerability and pharmacokinetics in participants with advanced solid tumors harboring RAS mutations or amplifications.

Interventions

  • Drug HRS-7172 Tablets
    HRS-7172 tablets.

Primary outcome measures

  • Incidence and severity of adverse events (AEs) [Time frame: From screening period up to 30 days after the last dose.]
  • Incidence and severity of serious adverse events (SAEs) [Time frame: From screening period up to 30 days after the last dose.]
  • Dose-limiting toxicity (DLT) [Time frame: From day 1 to day 24.]
  • Maximum tolerated dose (MTD) [Time frame: From day 1 to day 24.]
  • Recommended Phase II Dose (RP2D) [Time frame: From day 1 to day 24.]
Secondary outcome measures (10)
  • Objective response rate (ORR) [Time frame: About 24 months.]
  • Duration of response (DoR) [Time frame: About 24 months.]
  • Disease control rate (DCR) [Time frame: About 24 months.]
  • Progression-free survival (PFS) [Time frame: About 24 months.]
  • Overall survival (OS) [Time frame: About 24 months.]
  • Maximum plasma concentration (Cmax) [Time frame: About 24 months.]
  • Time to maximum concentration (Tmax) [Time frame: About 24 months.]
  • Elimination half-life (t1/2) [Time frame: About 24 months.]
  • Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t) [Time frame: About 24 months.]
  • Area under concentration-time curve from time 0 to infinity (AUC0-∞) [Time frame: About 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 old;
  • ECOG performance status (PS) score of 0 or 1;
  • Life expectancy > 3 months;
  • At least one measurable lesion per RECIST v1.1;
  • Adequate organ function.

Exclusion criteria

  • 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 · 1 center
  • Fudan University Affiliated Cancer Hospital — Shanghai

Identifiers

NCT: NCT07142980 · HRS-7172-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗