Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors

NCT06955390 | Not Yet Recruiting Phase 1

• 1 other identifier: ST-HRS4642-SHRA2102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity(DLT)

  one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle.

  At the end of Cycle 1 (each cycle is 14 days)

• Objective Response Rate (ORR)

  the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  up to 1 year

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  up to 2 year

• Overall survival(OS)

  up to 2 year

• Disease Control Rate (DCR)

  up to 1 year

• Duration of response (DoR)

  up to 1 year

• Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory

  Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

SHR-A2102+HRS-4642

Drug: SHR-A2102+HRS-4642

Interventions

SHR-A2102+HRS-4642 DRUG

A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted.

Treatment 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 the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements
• The age of signing the informed consent is from 18 to 75 years old, regardless of gender
• Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
• The ECOG score is 0 or 1
• Expected survival ≥12 weeks
• At least one measurable lesion according to RECIST v1.1 criteria
• Good level of organ function
• Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods

You may not qualify if:

• subjects with uncontrolled or active brain metastasis；
• subjects with clinical significant lung disease;
• subjects with history of autoimmune diseases;
• Known active hepatitis B or C infection;
• Subjects with severe cardiovascular and cerebrovascular diseases
• Uncontrolled tumor-related pain
• Severe infections that require intravenous antibiotic, antiviral or antifungal control
• Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion
• Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
• Known allergic to any compound of SHR-A2102 or HRS-4642
• Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Study Officials

• Qiming Wang, Professor

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiming Wang, Professor

CONTACT

+8613783590691; qimingwang1006@126.com

Zhen He, Professor

CONTACT

Study Design

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

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 2, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)