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A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors

ConditionMalignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;

Patients with histologically or cytologically confirmed unresectable solid tumors;

At least one measurable lesion was identified per RECIST 1.1;

Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;

Disqualifiers

Patients with known active central nervous system (CNS) metastases;

History of other malignancy within the past 5 years, with exceptions defined in the protocol;

Patients with uncontrolled cancer pain;

Patients with serious cardiovascular and/or cerebrovascular diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-7787 Injection

    Drug

    SHR-7787 Injection.

  • SHR-1316 Injection

    Drug

    SHR-1316 Injection.

  • SHR-4849 Injection

    Drug

    SHR-4849 Injection.

  • Etoposide injection

    Drug

    Etoposide Injection.

  • Carboplatin injection

    Drug

    Carboplatin Injection.

  • Cisplatin injection

    Drug

    Cisplatin Injection.

  • BP102 Injection

    Drug

    BP102 Injection.

Treatment groups

400 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: SHR-7787 combined with SHR-1316Experimental treatment 2 interventions
Group B: SHR-7787 combined with SHR-4849Experimental treatment 2 interventions
Group C: SHR-7787 combined with etoposide and carboplatin/cisplatinExperimental treatment 4 interventions
Group D: SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatinExperimental treatment 5 interventions
Group E: SHR-7787 combined with SHR-4849 and SHR-1316Experimental treatment 3 interventions
Group F: SHR-7787 combined with SHR-1316 and BP102Experimental treatment 3 interventions
Group G: SHR-7787 combined with SHR-4849 and BP102Experimental treatment 3 interventions
Group H: SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatinExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)

Time frame
Expected to be two years after the start of the study.
2

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)

Time frame
About 1 year after study initiation.
3

Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)

Time frame
About 1 year after study initiation.
4

Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)

Time frame
About 1 year after study initiation.

Secondary outcomes

1

Objective response rate (ORR)

Time frame
About 1 year.
2

Duration of Response (DoR)

Time frame
About 1 year.
3

Disease Control Rate (DCR)

Time frame
About 1 year.
4

Progress Free Survival (PFS)

Time frame
About 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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