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Colorectal CancerPhase 1/2NCT06373133

SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer

A Phase 1/2 study testing SHR-8068, Adebrelimab and BP102 in people with Colorectal Cancer, run by West China Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Bevacizumabin in the treatment of microsatellite stable (MSS) advanced colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
SHR-8068, Adebrelimab and BP102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 May 2024to 1 Nov 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pathologically confirmed metastatic colorectal adenocarcinoma;
  • Age of 18-75 years old, both sexes;
  • predicted survival time ≥12 weeks;
  • Eastern Cooperative Oncology Group performance status (ECOG) score 0-2;
  • Participants who had failed second-line or higher standard-of-care systemic therapy and should have been treated with oxaliplatin, irinotecan, and fluorouracil were allowed to enroll if first-line therapy included three agents;
  • liver tumor burden ≤50% as assessed by enhanced CT or MRI;
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  • There were no serious complications (perforation, obstruction, massive bleeding, etc.) in the primary lesion;
  • According to RECIST1.1 criteria, there should be at least one measurable objective tumor lesion, the maximum diameter of which must be ≥1cm by spiral CT, and the maximum diameter of which must be ≥2cm by conventional CT or MRI; This procedure was performed within 28 days before enrollment.
  • Study participants had to have adequate organ function, as assessed by the following laboratory results within 1 week before enrollment (no blood transfusion, granulocyte colony-stimulating factor, or other medical support within 14 days before study drug administration) :
  • Blood routine examination: hemoglobin ≥90g/L; Platelet (PLT) ≥75×109/L; White blood cell (WBC) ≥3.0×109/L; Neutrophil (ANC) ≥1.5×109/L;
  • Blood biochemical examination: total bilirubin (TBI) ≤1.5× upper limit of normal (UNL); Serum creatinine (Cr) ≤1.5× upper limit of normal; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤5×UNL;
  • study participants with active hepatitis B or active hepatitis C, who must have received antiviral therapy for at least 14 days before the first dose of the study drug, If they have a hepatitis B virus (HBV) DNA titer test (not higher than 500 IU/mL or 2500 copies [cps]/mL) and a hepatitis C virus (HCV) RNA test (not higher than the lower limit of detection of the assay), can be enrolled in the trial, and are willing to continue to receive effective antiviral therapy during the study;
  • Patients volunteered to participate and provided written informed consent.

Who cannot join

  • a history of other malignancies with disease-free survival <5 years (except cured basal cell carcinoma of the skin, cured carcinoma in situ of the cervix, and gastrointestinal cancer proven cured by endoscopic mucosal resection);
  • participated in other drug clinical trials within four weeks;
  • patients with known CNS metastases or a history of CNS metastases before screening. For patients with clinically suspected central nervous system metastasis, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) was required within 28 days before informed consent to rule out central nervous system metastasis.
  • patients with a long history of chronic diarrhea or complete intestinal obstruction;
  • urinalysis showed urinary protein ≥2+ or 24-hour urinary protein ≥1g;
  • Drug-uncontrolled hypertension (systolic blood pressure > 140 MMHG or diastolic blood pressure > 90mmHg);
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  • a history of severe bleeding (> 30ml per episode) within 3 months or hemoptysis (> 5ml per episode) within 1 month or thromboembolic events (including pulmonary embolism, cerebral infarction, etc.) within 12 months;
  • had undergone surgical treatment (excluding biopsy) within 6 weeks or had unhealed surgical incisions;
  • long-term unhealed wounds or incompletely healed fractures;
  • imaging shows that the tumor has invaded the vital blood vessels or the patient's tumor has a high possibility of invading the vital blood vessels during treatment, which may cause fatal bleeding;
  • with a history of unstable angina pectoris; Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTcF ≥450 ms in men and ≥470 ms in women) required long-term use of antiarrhythmic drugs and New York Heart Association (NYHA) grade ≥II cardiac dysfunction.
  • patients with abnormal coagulation function and bleeding tendency (INR within the normal range without anticoagulant therapy must be met within 14 days before the first medication); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Low-dose warfarin (1 mg orally once daily) or low-dose aspirin (at a dose of up to 100 mg daily) for preventive purposes were allowed if the International Normalized Ratio of prothrombin time (INR) was 1.5 or less.
  • participants with an active or prior autoimmune disease or risk (e.g., organ transplant requiring immunosuppressive therapy) that may relapse. However, participants with type 1 diabetes, hypothyroidism for which they were receiving hormone-replacement therapy only, or skin conditions for which no systemic treatment was required (e.g., vitiligo, psoriasis, or alopecia) were allowed.
  • have had a history of interstitial lung disease or noninfectious pneumonia, such as symptomatic disease or a previous pulmonary history that may preclude assessment or management of study-drug-related pulmonary toxicity;
  • Participants with a history of active pulmonary tuberculosis infection within 1 year before the first dose of the study drug and a history of active pulmonary tuberculosis infection more than 1 year before were considered eligible if they had no evidence of current active pulmonary tuberculosis, as assessed by the investigator;
  • severe uncontrolled medical illness or acute infection (fever > 38 ° C);
  • study participants who required systemic treatment with corticosteroids (>10 mg/ day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of the study drug. Note: In the absence of active autoimmune disease, inhaled or topical steroid hormones, or adrenal hormone replacement therapy with an equivalent dose of ≤10 mg prednisone per day, were allowed. Short-term (≤ 7 days) use of glucocorticoids was permitted for preventive treatment (e.g., contrast allergy) or for the treatment of nonautoimmune conditions (e.g., delayed hypersensitivity from a contact allergen).
  • study participants who had been treated with any antibody/drug (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, anti-LAG-3 antibodies, etc.) targeting a T-cell co-regulatory protein (immune checkpoint);
  • study participants with a history of allergic or hypersensitivity reactions to study drug components;
  • have immunodeficiency diseases or HIV infection;
  • pregnant or lactating women or patients of childbearing potential (men or women who have been without menstruation for less than 1 year) who are unwilling to use contraception;
  • concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or prevent the patient from completing the study;
  • who were deemed by the investigator to be ineligible for participation in the trial.

About this study

Official title: An Exploratory Clinical Trial of SHR-8068 Combined With Aldebelizumab and BP102 in the Treatment of Refractory Colorectal Cancer

To evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Bevacizumabin in the treatment of microsatellite stable (MSS) advanced colorectal cancer.

Read the detailed description

Previous studies have found that PD-1 or PD-L1 inhibitors combined with CTLA-4 inhibitors have better efficacy than PD-1 or PD-L1 inhibitors alone. Anti-angiogenesis targeted drugs can enhance the anti-tumor effects of immune checkpoint inhibitors by reducing the activity of immunosuppressive cells and normalizing tumor vascular structure, and its combination with immunotherapy has become a standard regimen in liver cancer. Based on the above, this study aims to explore the efficacy and safety of SHR-8068 and adbelizumab combined with bevacizumab in the treatment of MSS type of metastatic colorectal cancer.

Being tested
SHR-8068, Adebrelimab, BP102
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-8068Drug

    Also called Anti-CTLA4 monoclonal antibody

    1mg/kg，ivgtt, d1, q6w or 4mg/kg，ivgtt, d1, q12w

  • AdebrelimabDrug

    Also called SHR-1316

    1200mg, ivgtt, d1, q3w

  • BP102Drug

    Also called Bevacizumab

    7.5mg/kg, ivgtt, d1, q3w

Study groups in NCT06373133
Study groupRoleWhat they receive
SHR-8068+Adebrelimab+BP102ExperimentalThe first 9 subjects will be treated with low dose SHR-8068 (1mg/kg, q6w), and the subsequent subjects will be treated with high dose SHR-8068 (4mg/kg, q12w) if the toxicity of DLT is tolerable during the observation period.
Receives: Drug: SHR-8068; Drug: Adebrelimab; Drug: BP102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity

    The dose is considered tolerable if the incidence of DLT is less than 33.3%.

    Measured: The first 21 days of the first cycle of medication

  2. PFS

    Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06373133
Sponsor's protocol ID
2024 (82)
Status last verified
Apr 2024
First submitted
15 Apr 2024
Last updated
18 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang P, Li X, Wang X, Yang Y, Wang J, Cao D. SHR-8068 combined with adebrelimab and bevacizumab in the treatment of refractory advanced colorectal cancer: study protocol for a single-arm, phase Ib/II study. Front Immunol. 2024 Oct 9;15:1450533. doi: 10.3389/fimmu.2024.1450533. eCollection 2024.

    PubMed 39445023

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-8068, Adebrelimab and BP102 in people with Colorectal Cancer, run by West China Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: The first 21 days of the first cycle of medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06373133, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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