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Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom

ConditionAdvanced Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years old (including boundary values)

Volunteer to participate in this clinical study and sign informed consent;

ECOG score 0-1;

Expected survival ≥3 months;

Disqualifiers

Have previously used or are currently using HIF inhibitors.

Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.

Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.

Undergoing major surgical treatment within a certain period of time after the first administration of medication (excluding diagnosis) or expecting major surgical treatment during the study period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-8068；Adebrelimab ；Bevacizumab

    Drug

    SHR-8068+ Adebrelimab + Bevacizumab

  • SHR-8068 ; SHR-4610

    Drug

    SHR-8068+ SHR-4610

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: SHR-8068+ Adebrelimab + BevacizumabExperimental treatment 1 intervention
Group B: SHR-8068+ SHR-4610Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

DLT defined as the Incidence and severity of adverse events

Time frame
21days after the first administration of each subject
2

Overall response rate(ORR)

Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator

Time frame
from first dose to disease progression or death, whichever comes first, up to 3 years

Secondary outcomes

1

Progression-free survival (PFS) by investigator

Defined as time from first administration until progression or death as assessed by the investigator

Time frame
Until progression or death, assessed up to approximately 3 year
2

Duration of response (DOR) by investigator assessment

Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator

Time frame
Until progression or death, assessed up to approximately 3 year
3

Disease control rate (DCR) by investigator assessment

Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator

Time frame
Until progression, assessed up to approximately 3 year
4

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

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

Time frame
until to 90 days after the last dose，assessed up to approximately 3 years

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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