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A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors

ConditionAdvanced Malignancy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participate in the study voluntarily, sign the informed consent form.

Subjects were able to provide primary or metastatic cancer samples.

At least one measurable lesion (RECIST version 1.1).

ECOG 0~1.

Disqualifiers

With untreated brain metastasis or active central nervous system tumor metastases.

Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.

Patients with other malignant tumors in the past or at the same time.

Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-7782 Injection

    Drug

    SHR-7782 injection.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: SHR-7782 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limited Toxicity (DLT)

Time frame
Up to 21 days.
2

Maximum Tolerated Dose (MTD)

Time frame
Up to 6 months.
3

Recommended Phase II Dose (RP2D)

Time frame
Up to 21 days.

Secondary outcomes

1

Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria

Time frame
Up to approximately 24 months.
2

Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria

Time frame
Up to approximately 24 months.
3

Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria

Time frame
Up to approximately 24 months.
4

Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria

Time frame
Up to approximately 24 months.

Other outcomes

Sponsors and contacts

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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