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

NCT07142980 | Recruiting Phase 1

• 1 other identifier: HRS-7172-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Outcome Measures

Primary Outcomes (5)

• Incidence and severity of adverse events (AEs)

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

• Incidence and severity of serious adverse events (SAEs)

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

• Dose-limiting toxicity (DLT)

  From day 1 to day 24.

• Maximum tolerated dose (MTD)

  From day 1 to day 24.

• Recommended Phase II Dose (RP2D)

  From day 1 to day 24.

Secondary Outcomes (10)

• Objective response rate (ORR)

  About 24 months.

• Duration of response (DoR)

  About 24 months.

• Disease control rate (DCR)

  About 24 months.

• Progression-free survival (PFS)

  About 24 months.

• Overall survival (OS)

  About 24 months.

Study Arms (1)

HRS-7172 Group

EXPERIMENTAL

Oral HRS-7172.

Drug: HRS-7172 Tablets

Interventions

HRS-7172 Tablets DRUG

HRS-7172 tablets.

HRS-7172 Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Affiliated Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Rongfu Mao

CONTACT

+86-021-61053363; rongfu.mao@hengrui.com

Jizhao Li

CONTACT

+86-021-61053363; jizhao.li.jl565@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (1)