A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject has provided informed consent prior to initiation of any study-procedures

Age from 18 to 75 years old at the time of signing the informed consent

Histologically or cytologically confirmed solid tumors

At least one measurable lesion was identified per RECIST 1.1

Disqualifiers

Subjects with active central nervous system (CNS) metastasis.

Subjects with a history of malignant tumors within 5 years prior to the first dose

Subjects with uncontrolled cancer pain.

Subjects with severe cardiovascular disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

    Drug

    SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Treatment group AExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT:the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)

Time frame
up to 21 days
2

Incidence and severity of AE/SAE:According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage)

Time frame
up to 24 months
3

Objective Response Rate (ORR) as Assessed by investigators(The second stage)

Time frame
up to 24 months

Secondary outcomes

1

ORR(The first stage)

Objective Response Rate (ORR) as Assessed by investigators. The proportion of subjects whose best response was PR or CR according to RECIST1.1

Time frame
up to 24 months
2

DoR(The first stage)

Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.

Time frame
up to 24 months
3

DCR(The first stage)

Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1

Time frame
up to 24 months
4

PFS(The first stage)

Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

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