Solid TumorPhase 1NCT04400383
Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors
A Phase 1 study testing AB011 Injection in people with Solid Tumor and Gastric Cancer, run by CARsgen Therapeutics Co., Ltd. at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Gastric Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- AB011 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 12 sitesChina
- Study dates
- 4 Jun 2020to 28 Sep 2023
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
- 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.
Who cannot join
- 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;
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- 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;
- 10.Patients with HCV infection but who with the HCV-RNA lower than the lower limit of detection can be enrolled ;
- 11.Patients with interstitial lung disease or Pulmonary function abnormalities which were identified by the investigator as clinically significant;
- 12.Patients who received any anti-CLDN18.2 treatment;
- 13.Patients with significant medical history of cardiovascular and cerebrovascular diseases;
- 14.Patient with high risks of gastrointestinal hemorrhage at the investigator's discretion;
- 15.Patients who need long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) ;
- 16.Known alcohol use or drug dependence;
- 17.Patients with mental disorders or poor compliance;
- 18.Pregnant or lactating women;
- 19.Past severe allergic reactions or allergies to known components of AB011 injection ;
- 20.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;
- 22.Live attenuated vaccine was administered within 4 weeks prior to initial administration of the study drug;
- 23.Patients who with other serious systemic diseases or cannot participate in this trial due to other reasons, at the investigator's discretion.
- Stage 2:
- 1. Received any other unmarketed investigational drug within 4 weeks prior to initial use of the investigational drug;
- 2. Patients with gastric adenocarcinoma and gastric cancer/esophagogastric junction adenocarcinoma have allergies, intolerations, contraindications or other unsuitable applications of capecitabine or oxaliplatin regimen (such as complete lack of known dihydropyrimidine dehydrogenase activity, etc.);Subjects with pancreatic cancer have allergies, intolerations, contraindications, or other inappropriate use of gemcitabine, other drugs or any of the components that may be used in the albumin-bound paclitaxel regimen;
- 3. If the patient has received local treatment such as radiotherapy for locally advanced unresectable or metastatic gastric/oesophagogastric junction cancer or pancreatic cancer, unless the treatment was completed >28 days before the first administration of the study drug.Patients who received palliative radiotherapy with peripheral bone metastases and recovered from all acute toxicity ≥ 14 days prior to initial administration of the study therapy were eligible for inclusion;
- 4. Patients with gastric/oesophagogastric junction carcinoma are known to have grade ≥2 peripheral sensory neuropathy, unless loss of deep tendon reflex is the only neurological abnormality;
- 5. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug;
- 6.Received systemic glucocorticoid (prednisone > 10mg/ day or equivalent dose of the same drug) or other immunosuppressant treatment within 14 days prior to initial use of the study drug; The exceptions are: local, ocular, intraarticular, intranasal, and inhaled glucocorticoids;Short-term use of glucocorticoids for prophylactic treatment (e.g. to prevent contrast allergy);
- 7.Patients with AEs from previous treatment that have not recovered to ≤1(CTCAE 5.0）;
- 8. 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;
- 9. Patients with any active infection which requires systemic treatment with of anti-infection currently;
- 10. Patients with medical history of immune deficiency, Including positive HIV antibodies;
- 11. Patients with hepatitis B;
- 12.Patients with HCV infection but who with the HCV-RNA lower than the lower limit of detection can be enrolled ;
- 13.Patients who have interstitial lung disease or Pulmonary function abnormalities which were identified by the investigator as clinically significant;
- 14.Patients received any anti-CLDN18.2 treatment;
- 15.Patients with have significant medical history of cardiovascular and cerebrovascular diseases;
- 16.Patient with high risks of gastrointestinal hemorrhage at the investigator's discretion;
- 17.Patients who need long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) ;
- 18.Known alcohol use or drug dependence;
- 19.Patients with mental disorders or poor compliance;
- 20.Pregnant or lactating women;
- 21.Past severe allergic reactions or allergies to known components of AB011 injection;
- 22.Persistent recurrent vomiting (defined as ≥3 vomiting in 24 hours);
- 23. 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;
- 24.Live attenuated vaccine was administered within 4 weeks prior to initial administration of the study drug;
- 25.Patients have other serious systemic diseases or cannot participate in this trial due to other reasons, at the investigator's discretion.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Xiangya Hospital Central South University
Changsha, Hunan, 410008
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Anhui Provincial Hospital
Hefei, Anhui, 230036
Huaihua Second People's Hospital
Huaihua, Hunan, 418099
Linyi Cancer Hospital
Linyi, Shandong, 276002
Zhongshan Hospital, Zhongshan University
Shanghai, Shanghai Municipality, 200032
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Henan Cancer Hospital
Zhengzhou, Henan, 450003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: 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
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.
Read the 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 tumors. The study is composed of two stages: stage I is single treatment and stage II is combo treatment.
- Conditions
- Solid Tumor, Gastric Cancer, Pancreatic Adenocarcinoma
- Being tested
- AB011 Injection
- Keywords
- advanced solid tumors, Gastric Cancer, Esophagogastric Junction Cancer, Pancreatic Adenocarcinoma, Claudin 18.2, CLDN18.2, monoclonal antibody
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB011 InjectionDrug
Also called recombinant humanized anti-Claudin 18.2 monoclonal antibody injection, recombinant humanized anti-CLDN 18.2 monoclonal antibody injection
Stage 1 Single treatment: AB011 Injection with dose escalation of 1mg/kg up to 40mg/kg, as well as dose expansion with recommended dose level from dose escalation.
Stage 2 Combo Treatment: AB011 combine XELOX( GC) or Gem/nab-P (PC) Injection with dose escalation of 10mg/kg up to 30mg/kg, as well as dose expansion with recommended dose level from dose escalation.
| Study group | Role | What they receive |
|---|---|---|
| AB011 Injection | Experimental | AB011 Injection treatment. This phase 1 trial will include two stages, a single treatment stage and a Combo treatment stage. Receives: Drug: AB011 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage1：Incidence of adverse events AE of single and multiple dose (according to NCI CTCAE 5.0)
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From First dose to last patient progression or 6 months, whichever came first
Stage1：Incidence of adverse events SAE of single and multiple dose (according to NCI CTCAE 5.0)
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From First dose to last patient progression or 6 months, whichever came first
Stage 1: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Measured: From first dose up to 28 days
Stage 2：Incidence of adverse events AE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From First dose to last patient progression or 12 months, whichever came first
Stage 2：Incidence of adverse events SAE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From First dose to last patient progression or 12 months, whichever came first
Stage 2: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Measured: From first dose up to 21 days
Secondary outcomes (18)
Stage 1: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of 6 cycle( each cycle is 28 days), whichever came first
Stage 2: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: clearance rate (CL) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or 6 cycle( dose increase), 8 cycle (dose extension), whichever came first
Stage 2: Pharmacokinetics: clearance rate (CL) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: half-life (T1/2) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: Pharmacokinetics: half-life (T1/2) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: volume of distribution (Vd) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: volume of distribution (Vd) with immunoanalytical method
AUC will be recorded from the PK serum samples collected.
Measured: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Immunogenicity
Incidence of anti-drug antibodies
Measured: Up to 8 months (end of treatment)
Efficacy: objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
Measured: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
Measured: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
Measured: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
Measured: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
Measured: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start4 Jun 2020
- Primary completion8 Jul 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital
- Responsible party
- Sponsor
- Investigators
- Jin Li, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400383
- Sponsor's protocol ID
- AB011-ST-01
- Status last verified
- May 2024
- First submitted
- 18 May 2020
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04400383
- Acronym / sponsor ID
- AB011-ST-01
- Conditions
- Solid Tumor, Gastric Cancer, Pancreatic Adenocarcinoma
- Keywords
- advanced solid tumors, Gastric Cancer, Esophagogastric Junction Cancer, Pancreatic Adenocarcinoma, Claudin 18.2, CLDN18.2, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 8 Jul 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 tumors. The study is composed of two stages: stage I is single treatment and stage II is combo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB011 Injection | Experimental | Drug: AB011 InjectionAB011 Injection treatment. This phase 1 trial will include two stages, a single treatment stage and a Combo treatment stage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (49 listed)
- 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 );
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB011 InjectionAlso: recombinant humanized anti-Claudin 18.2 monoclonal antibody injection, recombinant humanized anti-CLDN 18.2 monoclonal antibody injectionStage 1 Single treatment: AB011 Injection with dose escalation of 1mg/kg up to 40mg/kg, as well as dose expansion with recommended dose level from dose escalation. Stage 2 Combo Treatment: AB011 combine XELOX( GC) or Gem/nab-P (PC) Injection with dose escalation of 10mg/kg up to 30mg/kg, as well as dose expansion with recommended dose level from dose escalation. | Drug | AB011 Injection |
Primary outcome
Stage1：Incidence of adverse events AE of single and multiple dose (according to NCI CTCAE 5.0)
Time frame: From First dose to last patient progression or 6 months, whichever came first
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Stage1：Incidence of adverse events SAE of single and multiple dose (according to NCI CTCAE 5.0)
Time frame: From First dose to last patient progression or 6 months, whichever came first
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Stage 1: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Time frame: From first dose up to 28 days
DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Stage 2：Incidence of adverse events AE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)
Time frame: From First dose to last patient progression or 12 months, whichever came first
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Stage 2：Incidence of adverse events SAE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)
Time frame: From First dose to last patient progression or 12 months, whichever came first
An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Stage 2: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Time frame: From first dose up to 21 days
DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
18 secondary outcomes
Stage 1: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of 6 cycle( each cycle is 28 days), whichever came first
Stage 2: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: clearance rate (CL) with immunoanalytical method
Time frame: Up to progression of disease after injection, or 6 cycle( dose increase), 8 cycle (dose extension), whichever came first
Stage 2: Pharmacokinetics: clearance rate (CL) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: Pharmacokinetics: half-life (T1/2) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: Pharmacokinetics: half-life (T1/2) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Stage 1: volume of distribution (Vd) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
Stage 2: volume of distribution (Vd) with immunoanalytical method
Time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
Immunogenicity
Time frame: Up to 8 months (end of treatment)
Efficacy: objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Efficacy: overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Li principal investigator
Shanghai East Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB011 Injection in people with Solid Tumor and Gastric Cancer, run by CARsgen Therapeutics Co., Ltd. at 12 sites in China.
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 18 inclusion and 49 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: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stage1：Incidence of adverse events AE of single and multiple dose (according to NCI CTCAE 5.0) (time frame: From First dose to last patient progression or 6 months, whichever came first). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2024.