Health TrialsbyHealthPanel

A Study of HRS-2329 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 an open-label, multi-center phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of HRS-2329 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;

Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor RAS mutations or amplifications and have failed standard treatment;

ECOG performance status (PS) score of 0 or 1;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-2329 Tablet

    Drug

    Oral HRS-2329 tablet.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: HRS-2329 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs).

Graded as per CTCAE v5.0.

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

Incidence and severity of serious adverse events (SAEs).

Graded as per CTCAE v5.0.

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

Dose-limiting toxicity (DLT).

Time frame
From Day 1 to Day 21.
4

Maximum tolerated dose (MTD).

Time frame
From Day 1 to Day 21.

Secondary outcomes

1

Maximum plasma concentration (Cmax).

Time frame
About 24 months.
2

The time to maximum concentration (Tmax).

Time frame
About 24 months.
3

Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t).

Time frame
About 24 months.
4

Area under concentration-time curve from time 0 to infinity (AUC 0-∞).

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
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