A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-10-31

Brief Summary

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The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-4508+ Capecitabine

Group Type EXPERIMENTAL

HRS-4508+ Capecitabine

Intervention Type DRUG

HRS-4508+ Capecitabine

HRS-4508+ Trastuzumab

Group Type EXPERIMENTAL

HRS-4508+ Trastuzumab

Intervention Type DRUG

HRS-4508+ Trastuzumab

HRS-4508+ Trastuzumab+ Pertuzumab

Group Type EXPERIMENTAL

HRS-4508+ Trastuzumab+ Pertuzumab

Intervention Type DRUG

HRS-4508+ Trastuzumab+ Pertuzumab

HRS-4508+ Trastuzumab+ Capecitabine

Group Type EXPERIMENTAL

HRS-4508+ Trastuzumab+ Capecitabine

Intervention Type DRUG

HRS-4508+ Trastuzumab+ Capecitabine

Trastuzumab+ Capecitabine

Group Type EXPERIMENTAL

Trastuzumab+ Capecitabine

Intervention Type DRUG

Trastuzumab+ Capecitabine

HRS-4508+A1811

Group Type EXPERIMENTAL

HRS-4508+A1811

Intervention Type DRUG

HRS-4508+A1811

Interventions

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HRS-4508+ Capecitabine

Intervention Type DRUG

HRS-4508+ Trastuzumab

Intervention Type DRUG

HRS-4508+ Trastuzumab+ Pertuzumab

Intervention Type DRUG

HRS-4508+ Trastuzumab+ Capecitabine

Intervention Type DRUG

Trastuzumab+ Capecitabine

Intervention Type DRUG

HRS-4508+A1811

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 to 75 years old; Both men and women are welcome;
2. The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
3. ECOG ratings of 0 or 1.
4. Expected survival period ≥ 12 weeks.
5. At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
6. Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.

Exclusion Criteria

1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
2. There have been significant severe infections and major surgeries in the past 4 weeks
3. Existence of previous or concurrent malignant tumors
4. Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
5. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No