A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC

NCT06632405 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CAnTiH
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase II, explorative, open-labeled, multi-centered, double-arm, investigator-initiated clinical trial of Camrelizumab (an anti-PD-1 antibody) in combination with Nab-paclitaxel (a chemotherapeutic agent against breast cancer) and Levocetirizine (an antihistamine) in patients with advanced triple-negative breast cancer. 60 subjects will be enrolled in multiple centers. This study aims to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  The propotion of subjects with CR or PR.

  from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）

Secondary Outcomes (10)

• Adverse events/Serious adverse events

  from the first drug administration to within 90 days for the last dose

• Disease Control Rate (DCR)

  from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）

• Clinical benefit rate (CBR)

  propotion of subjects with CR, PR, or SD for >=6 months （up to 36 weeks）

• Duration of response (DoR)

  from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）

• Time to response (TTR)

  from the first drug administration up to the first occurrence of progression （up to 36 weeks）

Study Arms (2)

Camrelizumab+Nab-Paclitaxel+Levocetirizine

EXPERIMENTAL

Camrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv, d1, q3w, plus Nab-Paclitaxel 100mg/m2, iv, d1,8,15 q4w, and Levocetirizine 5mg, po, 3 days before 1st administration

Drug: Camrelizumab; Drug: Nab paclitaxel; Drug: Levocetirizine Hydrochloride

Camrelizumab+Nab-Paclitaxel

SHAM COMPARATOR

Camrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv, d1, q3w, plus Nab-Paclitaxel 100mg/m2, iv, d1,8,15 q4w

Drug: Camrelizumab; Drug: Nab paclitaxel

Interventions

Camrelizumab DRUG

Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

Camrelizumab+Nab-Paclitaxel; Camrelizumab+Nab-Paclitaxel+Levocetirizine

Nab paclitaxel DRUG

Nab paclitaxel 100mg/m2 will be administered as an intravenous infusion every 4 weeks in d1,8,15until unacceptable toxic effects or disease progression or other termination criteria appeared.

Camrelizumab+Nab-Paclitaxel; Camrelizumab+Nab-Paclitaxel+Levocetirizine

Levocetirizine Hydrochloride DRUG

5mg daily, start 3 days before the 1st administration

Camrelizumab+Nab-Paclitaxel+Levocetirizine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the written informed consent;
• Aged ≥ 18 and ≤ 70 years old;
• Confirmed recurrent and metastatic triple negative breast cancer by imaging and pathology (ER negative (IHC ER positive percentage \< 1%), PR negative (IHC PR positive percentage \< 1%), HER2 negative (IHC -/+or IHC++but FISH/CISH -)), at least one measurable focus meeting the RECIST v1.1 standard;
• Untreated local recurrence of unresectable TNBC or untreated distant metastasis of TNBC
• Must be able to swallow tablets;
• Clarify the positive status of PD-L1 expression and CPS score ≥ 1
• ECOG score: 0 to 1;
• Expected survival period ≥ 12 weeks;
• The results of patient's blood tests are as follows (excluding the use of any blood components and cell growth factors during screening):
• Absolute neutrophil count ≥ 1.5 × 109/L;
• Platelets ≥ 100 × 109/L;
• Hemoglobin ≥ 9g/dL;
• Serum albumin ≥ 3g/dL;
• Thyroid stimulating hormone (TSH) ≤ ULN (if abnormal, T3 and T4 levels should be examined simultaneously. If T3 and T4 levels are normal, they can be included in the group);
• Bilirubin ≤ 1.0 times ULN (Gilbert's syndrome or liver metastasis subject total bilirubin ≤ 1.5 times ULN);

You may not qualify if:

• Received other interventional clinical trials within 28 days before the first dose;
• Failure to recover from adverse reactions of previous treatment
• Neurological disorders of grade ≥ 2
• Untreated active brain metastases or meningeal metastases
• Previously received nab-paclitaxel neoadjuvant therapy or adjuvant therapy and experienced local recurrence or distant metastasis within 12 months;
• Has experienced severe allergic reactions to other monoclonal antibodies;
• Received other anti-tumor treatments within 28 days before the first administration;
• Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
• Received antibody or T cell co stimulatory therapy such as PD-1, PD-L1, PD-L2, CTLA-4, Tim3, LAG3, etc;
• Special genetic diseases (including rare galactose intolerance, primary lactase deficiency, or glucose galactose malabsorption);
• Active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma without any intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators may not be included);
• Heart diseases, such as:
• NYHA grade 2 or above heart failure
• Unstable angina pectoris
• Have experienced a myocardial infarction within the past year

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

camrelizumab; Taxes; levocetirizine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Jieqiong Liu

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieqiong Liu

CONTACT

86-13922272706; liujieqiong01@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: October 9, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 26, 2025

Record last verified: 2024-10