Health TrialsbyHealthPanel

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

ConditionAdvanced Solid Tumors Harboring RAS Mutations or Amplifications
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-7172 Tablets

    Drug

    HRS-7172 tablets.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: HRS-7172 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs)

Time frame
From screening period up to 30 days after the last dose.
2

Incidence and severity of serious adverse events (SAEs)

Time frame
From screening period up to 30 days after the last dose.
3

Dose-limiting toxicity (DLT)

Time frame
From day 1 to day 24.
4

Maximum tolerated dose (MTD)

Time frame
From day 1 to day 24.

Secondary outcomes

1

Objective response rate (ORR)

Time frame
About 24 months.
2

Duration of response (DoR)

Time frame
About 24 months.
3

Disease control rate (DCR)

Time frame
About 24 months.
4

Progression-free survival (PFS)

Time frame
About 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now