Recurrent or Metastatic Solid TumorsPhase 1A-337NCT06093698
An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases
A Phase 1 study testing Recombinant Anti-EpCAM-CD3 Antibody Injection in people with Recurrent or Metastatic Solid Tumors, run by ITabMed Co., Ltd..
Trial summary
Title: An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Metastatic Solid Tumors
- What is being tested?
- Recombinant Anti-EpCAM-CD3 Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 18-75 years, all genders
- Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no standard treatment options, or are not suitable for standard treatment at this stage.
- The interval between the first dose of investigational drug and previous major surgery, medical device treatment, or local radiotherapy was at least 28 days. At least 21 days between the first dose of investigational drug and previous cytotoxic chemotherapy, immunotherapy, or biological agents; At least 14 days between he first dose of investigational drug and previous tumor-related endocrinotherapy and minor surgery; The interval between he first dose of investigational drug and small molecule targeted drugs was at least 21 days or 5 half-lives, whichever is longer; At least 14 days interval between the first dose of investigational drug and antineoplastic chinese traditional medicines.
- Patients with at least one measurable lesion on the basis of RECIST v1.1.
- ECOG ≤ 1
- Patients are willing to provide archival tumor tissue or undergo fresh tissue biopsy.
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- Life expectancy is at least 3 months.
- Having adequate organ and bone marrow functional reserve, defined as follows:
- Blood routine (corrected with no growth factor support, blood transfusion, or other medication within 2 weeks before screening) ANC ≥ 1.5 ×109 /L,PLT≥ 75×109/L,HGB≥ 90 g/L
- hepatic parameters :TBIL ≤ 1.5 × ULN For patients with liver metastases or a history of Gilbert's syndrome/suspected disease,TBIL ≤ 3 ×ULN For patients without liver metastases,ALT≤ 2.5 ×ULN,AST≤ 2.5 ×ULN For patients with liver metastases,ALT or AST ≤ 5 ×ULN
- renal function:Cr≤ 1.5×ULN or CrCl≥ 45 mL/min (using The Cockcroft-Gault formula )
- coagulation function:APTT≤ 1.5 × ULN,INR≤ 1.5 × ULN. Patients who were in the therapeutic window for long-term use of anticoagulants who did not meet these criteria could be enrolled at the investigator's discretion.
- Participants are capable of providing written informed consent and adhering to the protocol.
Who cannot join
- Past or present malignant tumor diagnosed in the past 3 years and/or required treatment.Except for the completely resected basal and squamous cell skin cancers and any type in situ.
- Patients with CNS metastases, unless the metastases were treated and stable for at least 4 weeks and without taking systemic steroids ≥ 10 mg prednisone/day or equivalent.
- Patients suspected or confirmed immunocompromised:
- Patients with HIV
- Patients requiring systemic or local treatment with systemic steroids or any immunomodulatory drug (at a level that results in a systemic dose effect).E.g. High-dose oral or intravenous steroids > 10 mg/ day prednisone or its equivalent, or methotrexate > 15 mg once weekly).Allow topical, inhaled or topical use of steroids (at levels not thought to cause systemic dose effects);
- Patients with active autoimmune disease or a history of autoimmune disease with potential recurrence(e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autohemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).Exceptions are patients with type I diabetes, hypothyroidism that is manageable with hormone-replacement therapy, skin conditions (e.g., vitiligo, psoriasis, or alopecia) that require no systemic treatment, or childhood asthma/allergies that have resolved without any intervention in adulthood.
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- Patients with allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation)
- Any other condition that was considered by the investigator to place the patient at unacceptable risk as a result of receiving immunomodulatory therapy.
- Anticancer therapy, including hormonal therapy, biological therapy, cellular therapy, or radiation therapy, was administered within 4 weeks prior to the initiation of study treatment, except in the following cases:
- Hormonal therapy for prostate cancer using gonadotropin-releasing hormone (GnRH) agonists.
- Hormone replacement therapy or oral contraceptives
- Participants with any disease, medical condition, or social factor that was judged by the investigator to be likely to affect the study results or adherence were excluded from the study according to the protocol:
- Uncontrolled acute infection or confirmed bacteremia.
- Patients with HIV or HBV,and HBV copy number > 1000/mL or HBV DNA titer > 200 IU/mL.And patients with HCV.
- Severe dyspnea, pulmonary insufficiency, or continuous oxygen therapy.
- The patients were classified as New York Heart Association (NYHA) class 3 or 4 or left ventricular ejection fraction (LVEF) < 50%.
- Myocardial infarction, unstable angina, stroke, or transient ischemic attack, or other cardiovascular events of grade III or higher, occurred within 6 months before dose administration.
- Severe arrhythmia or uncontrolled hypertension (systolic blood pressure > 180 mmHg and diastolic blood pressure > 100 mmHg) or diabetes mellitus.
- Patients with uncontrolled systemic infection.
- Patients with positive treponema pallidum antibody.
- Patients who had undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) or who had nonhealed wounds, ulcers, or fractures within 4 weeks before the administration of the first dose of investigational drug, with the exception of needle biopsy procedures.
- Patients with alcohol or drug dependence.
- Patients with mental disorders, including epilepsy or dementia, or poor adherence.
- Patients with tumor types of nonepithelial origin.
- Patients with received an EpCAM antibody class, CD3 dual antibody class, or CAR-T therapy.
- Patients who did not recover to grade 1 or less toxicity (CTCAE 5.0) from previous antineoplastic therapy(except alopecia) .Patients who did not recover to grade 1 or below (CTCAE 5.0) after radiotherapy (except no effect).
- Pregnant (positive pregnancy test), lactating women.Women of childbearing age who did not agree to use contraception for at least 3 months after signing the informed consent form until the end of the study.Women of childbearing age had a positive HCG test within 7 days before the first day of treatment.
- Male subjects who did not agree to use contraception for at least 3 months after signing the informed consent form until the end of the study (except surgical sterilization)
- Patients with a allergy to the study drug or its excipients.
- Patients who were deemed by the investigator to be ineligible for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study of A-337 in the Management of Malignant Solid Dose
Title: An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases
Read the detailed description
Protocol Number: IM-2021A Study Stage: Phase I Study Number: 2-3 sites Subject Number: up to 94 patients with recurrent or metastatic solid tumors, for whom there are no available effective standard treatments or for whom standard treatments have proven ineffective or intolerable.
- Conditions
- Recurrent or Metastatic Solid Tumors
- Being tested
- Recombinant Anti-EpCAM-CD3 Antibody Injection
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Anti-EpCAM-CD3 Antibody InjectionBiological
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | A-337dosage: 0.05, 0.15, 0.3, 0.6, 0.9, 1.2, 1.5 μg/kg/d Receives: Biological: Recombinant Anti-EpCAM-CD3 Antibody Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Incidence and Characteristics of Adverse Events of A-337 in the Treatment of malignant Solid Tumors
Incidence and characteristics of adverse events
Measured: At the end of Cycle 1 (each cycle is 28 days)
Evaluate the MTD and DLT of A-337 in the Treatment of malignant Solid Tumors
dose limited toxicity(DLT), maximum tolerance dose(MTD)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (12)
Evaluate the PK(Cmax) of A-337 in the Treatment of malignant Solid Tumors
Cmax
Measured: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(Tmax) of A-337 in the Treatment of malignant Solid Tumors
Tmax
Measured: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK（T1/2) of A-337 in the Treatment of malignant Solid Tumors
T1/2
Measured: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(Vd) of A-337 in the Treatment of malignant Solid Tumors
Vd
Measured: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(CL/F) of A-337 in the Treatment of malignant Solid Tumors
CL/F
Measured: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(MRT) of A-337 in the Treatment of malignant Solid Tumors
MRT
Measured: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(AUC) of A-337 in the Treatment of malignant Solid Tumors
AUC
Measured: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the efficacy evaluation（ORR） of A-337 in the Treatment of malignant Solid Tumors
ORR
Measured: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（DCR） of A-337 in the Treatment of malignant Solid Tumors
DCR
Measured: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（DDC） of A-337 in the Treatment of malignant Solid Tumors
DDC
Measured: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（PFS） of A-337 in the Treatment of malignant Solid Tumors
PFS
Measured: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（OS） of A-337 in the Treatment of malignant Solid Tumors
OS
Measured: At the end of each Cycle (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Solid TumorsStudies 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITabMed Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinghua Zhou, Doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093698
- Sponsor's protocol ID
- IM-2021A
- Acronym
- A-337
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of A-337 in the Management of Malignant Solid Dose
- ClinicalTrials.gov ID
- NCT06093698
- Acronym / sponsor ID
- A-337 / IM-2021A
- Conditions
- Recurrent or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- ITabMed Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
Title: An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases
Detailed description
Protocol Number: IM-2021A Study Stage: Phase I Study Number: 2-3 sites Subject Number: up to 94 patients with recurrent or metastatic solid tumors, for whom there are no available effective standard treatments or for whom standard treatments have proven ineffective or intolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: Recombinant Anti-EpCAM-CD3 Antibody InjectionA-337dosage: 0.05, 0.15, 0.3, 0.6, 0.9, 1.2, 1.5 μg/kg/d |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18-75 years, all genders
- Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no standard treatment options, or are not suitable for standard treatment at this stage.
- The interval between the first dose of investigational drug and previous major surgery, medical device treatment, or local radiotherapy was at least 28 days. At least 21 days between the first dose of investigational drug and previous cytotoxic chemotherapy, immunotherapy, or biological agents; At least 14 days between he first dose of investigational drug and previous tumor-related endocrinotherapy and minor surgery; The interval between he first dose of investigational drug and small molecule targeted drugs was at least 21 days or 5 half-lives, whichever is longer; At least 14 days interval between the first dose of investigational drug and antineoplastic chinese traditional medicines.
- Patients with at least one measurable lesion on the basis of RECIST v1.1.
- ECOG ≤ 1
Key exclusion criteria (30 listed)
- Past or present malignant tumor diagnosed in the past 3 years and/or required treatment.Except for the completely resected basal and squamous cell skin cancers and any type in situ.
- Patients with CNS metastases, unless the metastases were treated and stable for at least 4 weeks and without taking systemic steroids ≥ 10 mg prednisone/day or equivalent.
- Patients suspected or confirmed immunocompromised:
- Anticancer therapy, including hormonal therapy, biological therapy, cellular therapy, or radiation therapy, was administered within 4 weeks prior to the initiation of study treatment, except in the following cases:
- Participants with any disease, medical condition, or social factor that was judged by the investigator to be likely to affect the study results or adherence were excluded from the study according to the protocol:
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 |
|---|---|---|
| Recombinant Anti-EpCAM-CD3 Antibody InjectionIntravenous Infusion | Biological | single arm |
Primary outcome
Evaluate the Incidence and Characteristics of Adverse Events of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence and characteristics of adverse events
Evaluate the MTD and DLT of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 1 (each cycle is 28 days)
dose limited toxicity(DLT), maximum tolerance dose(MTD)
12 secondary outcomes
Evaluate the PK(Cmax) of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(Tmax) of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK（T1/2) of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(Vd) of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(CL/F) of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(MRT) of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the PK(AUC) of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Evaluate the efficacy evaluation（ORR） of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（DCR） of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（DDC） of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（PFS） of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of each Cycle (each cycle is 28 days)
Evaluate the efficacy evaluation（OS） of A-337 in the Treatment of malignant Solid Tumors
Time frame: At the end of each Cycle (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Qinghua Zhou, Doctor principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Anti-EpCAM-CD3 Antibody Injection in people with Recurrent or Metastatic Solid Tumors, run by ITabMed Co., Ltd..
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 30 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: opening soon, as of the sponsor's last update on 23 Oct 2023. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darong Dai, Bachelor (8618284820495, darong.dai@itabmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Incidence and Characteristics of Adverse Events of A-337 in the Treatment of malignant Solid Tumors (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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?
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 23 Oct 2023.