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A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer

ConditionColorectal Cancer
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-8068 injection in combination with anti-tumor therapies in subjects with colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Male or female ≥ 18 years old and ≤75 years old.

ECOG performance status of 0-1.

Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.

Disqualifiers

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

Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.

Part B: Palliative radiotherapy was completed within 14 days before the first dose.

Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-8068 Injection

    Drug

    SHR-8068 injection.

  • Adebrelimab Injection

    Drug

    Adebrelimab injection.

  • Bevacizumab Injection

    Drug

    Bevacizumab injection.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Part A GroupExperimental treatment 2 interventions
Group B: Part B GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response (pCR)

Time frame
About 7 months.
2

Progression Free Survival (PFS)

Time frame
About 18 months.

Secondary outcomes

1

Clinical Complete Response (cCR)

Time frame
About 60 months.
2

Disease Free Survival (DFS)

Time frame
About 60 months.
3

Event Free Survival (EFS）

Time frame
About 60 months.
4

Overall Survival (OS)

Time frame
About 60 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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