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

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: HRS-4508+ Trastuzumab+ Pertuzumab; Drug: HRS-4508+ Capecitabine; Drug: HRS-4508+ Trastuzumab; Drug: Trastuzumab+ Capecitabine; Drug: HRS-4508+A1811; Drug: HRS-4508+ Trastuzumab+ Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07140393

HRS-4508-202-BC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

HRS-4508+ Capecitabine

Experimental group

Treatment:

Drug: HRS-4508+ Capecitabine

HRS-4508+ Trastuzumab

Experimental group

Treatment:

Drug: HRS-4508+ Trastuzumab

HRS-4508+ Trastuzumab+ Pertuzumab

Experimental group

Treatment:

Drug: HRS-4508+ Trastuzumab+ Pertuzumab

HRS-4508+ Trastuzumab+ Capecitabine

Experimental group

Treatment:

Drug: HRS-4508+ Trastuzumab+ Capecitabine

Trastuzumab+ Capecitabine

Experimental group

Treatment:

Drug: Trastuzumab+ Capecitabine

HRS-4508+A1811

Experimental group

Treatment:

Drug: HRS-4508+A1811