Status:
COMPLETED
Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors
Lead Sponsor:
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsors:
Shanghai East Hospital
Conditions:
Solid Tumor
Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors.
Detailed Description
This study is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tum...
Eligibility Criteria
Inclusion
- Stage 1:
- 1\. Aged 18 to 80 years, either sex;
- 2\. Patients with histologically or cytologic confirmed advanced solid tumors should have failed the standard treatment, or have no standard treatment regimen available, or have no access to standard treatment;
- 3\. Tumor tissue samples is CLDN18.2 positive;
- 4\. According to RECIST1.1, there are at least one evaluable tumor lesion during dose escalation period (stage 1), and at least one measurable tumor lesion during dose expansion period (stage 2);
- 5\. The ECOG score is 0 to 1;
- 6\. Expected survival \> 3 months;
- 7\. Various organs in good condition;
- 8\. Fertile eligible patients (male and female) and their partners are willing to use a reliable method of contraception (hormones, barriers or abstinence) during the study and within 90 days after the last study treatment; women of childbearing potential must be tested for serum or urine pregnancy within 7 days before enrollment with negative results;
- 9\. Patients are informed of this study before the trial and sign written informed consent form.
Exclusion
- 1\. Received anti-tumor therapies within 4 weeks prior to first administration of study drug, except: within 6 weeks for nitrosoureas or mitomycin C, within 2 weeks or 5 half-life of drugs (whichever longer) for oral fluorouracils and small molecular targeted drugs, and within 2 weeks for traditional Chinese medicines with indications of anti-tumor;
- 2\. Received other non-marketed clinical trial drugs within 4 weeks prior to first administration of study drugs;
- 3\. Received major surgery or had significant trauma within 4 weeks prior to first administration of study drug;
- 4\. Received systemic corticosteroids or other immunosuppressors within 14 days prior to first administration of study drug;
- 5\. Patients with AEs from previous treatment that have not recovered to ≤1 (CTCAE 5.0 );
- 6\. Patients have central nervous system (CNS) metastasis or meningeal metastasis, or other evidences which demonstrate the CNS metastasis or meningeal metastasis are not controlled, resulting that patients are not eligible for enrollment at the investigator's discretion;
- 7\. Patients with any active infection which requires systemic treatment with of anti-infection currently;
- 8\. Patients with medical history of immune deficiency;
- 9\. Patients with hepatitis B;
- Patients with HCV infection but who with the HCV-RNA lower than the lower limit of detection can be enrolled ;
- Patients with interstitial lung disease or Pulmonary function abnormalities which were identified by the investigator as clinically significant;
- Patients who received any anti-CLDN18.2 treatment;
- Patients with significant medical history of cardiovascular and cerebrovascular diseases;
- Patient with high risks of gastrointestinal hemorrhage at the investigator's discretion;
- Patients who need long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) ;
- Known alcohol use or drug dependence;
- Patients with mental disorders or poor compliance;
- Pregnant or lactating women;
- Past severe allergic reactions or allergies to known components of AB011 injection ;
- Persistent recurrent vomiting (defined as ≥3 vomiting in 24 hours);
- 21\. Have other uncured malignant tumors in the past 5 years or at the same time, except cervical carcinoma in situ, basal cell carcinoma of the skin and other tumors with very low malignant degree;
- Live attenuated vaccine was administered within 4 weeks prior to initial administration of the study drug;
- Patients who with other serious systemic diseases or cannot participate in this trial due to other reasons, at the investigator's discretion.
- Stage 2:
- Inclusion Criteria:
- 1\. Aged 18 to 80 years, either sex;
- 2\. Patients with histologically or cytologic confirmed advanced gastric/oesophagus- gastric junction cancer or pancreatic cancer without systemic therapy (neoadjuvant therapy or postoperative adjuvant therapy, no tumor progression or recurrence within 6 months of last medication)
- 3\. Tumor tissue samples is CLDN18.2 positive ;
- 4\. According to RECIST1.1, there are at least one evaluable tumor lesion during dose escalation period (stage 1), and at least one measurable tumor lesion during dose expansion period (stage 2);
- 5\. The ECOG score is 0 to 1;
- 6\. Expected survival \> 3 months;
- 7\. Various organs in good condition;
- 8\. Fertile eligible patients (male and female) and their partners are willing to use a reliable method of contraception (hormones, barriers or abstinence) during the study and within 90 days after the last study treatment; women of childbearing potential must be tested for serum or urine pregnancy within 7 days before enrollment with negative results;
- 9\. Patients are informed of this study before the trial and sign written informed consent form.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04400383
Start Date
June 4 2020
End Date
September 28 2023
Last Update
May 24 2024
Active Locations (12)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230036
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003