Health TrialsbyHealthPanel

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

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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 HRS-4508 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 75 years old; Both men and women are welcome;

The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .

ECOG ratings of 0 or 1.

Expected survival period ≥ 12 weeks.

Disqualifiers

Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis

There have been significant severe infections and major surgeries in the past 4 weeks

Existence of previous or concurrent malignant tumors

Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication

Trial design

Design model

Sequential

Treatments tested in this trial

  • HRS-4508+ Capecitabine

    Drug

    HRS-4508+ Capecitabine

  • HRS-4508+ Trastuzumab

    Drug

    HRS-4508+ Trastuzumab

  • HRS-4508+ Trastuzumab+ Pertuzumab

    Drug

    HRS-4508+ Trastuzumab+ Pertuzumab

  • HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel

    Drug

    HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel

  • HRS-4508+ Trastuzumab + Nab-paclitaxel

    Drug

    HRS-4508+ Trastuzumab + Nab-paclitaxel

  • HRS-4508+ Trastuzumab+ Capecitabine

    Drug

    HRS-4508+ Trastuzumab+ Capecitabine

  • Trastuzumab+ Capecitabine

    Drug

    Trastuzumab+ Capecitabine

  • Trastuzumab+ Pertuzumab

    Drug

    Trastuzumab+ Pertuzumab

  • HRS-4508+SHR-A1811

    Drug

    HRS-4508+SHR-A1811

Treatment groups

120 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: HRS-4508+ CapecitabineExperimental treatment 1 intervention
Group B: HRS-4508+ TrastuzumabExperimental treatment 1 intervention
Group C: HRS-4508+ Trastuzumab+ PertuzumabExperimental treatment 1 intervention
Group D: HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxelExperimental treatment 1 intervention
Group E: HRS-4508+ Trastuzumab + Nab-paclitaxelExperimental treatment 1 intervention
Group F: HRS-4508+ Trastuzumab+ CapecitabineExperimental treatment 1 intervention
Group G: Trastuzumab+ CapecitabineActive comparator 1 intervention
Group H: Trastuzumab+ PertuzumabActive comparator 1 intervention
Group I: HRS-4508+SHR-A1811Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HRS4508 DLT

Time frame
3 weeks
2

HRS4508 MTD

Time frame
12 weeks
3

HRS4508 RP2D

Time frame
12 weeks
4

The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)

Time frame
2 years

Secondary outcomes

1

Blood concentrations of HRS-4508

Time frame
15 weeks
2

Blood concentrations of SHR-A1811

Time frame
9 weeks
3

Blood concentrations of Capecitabine

Time frame
2 weeks
4

Objective response rate (ORR)

Time frame
1 year

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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