An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases

NCT06093698 | Not Yet Recruiting Phase 1

• 1 other identifier: IM-2021A
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

Title: An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases

Conditions

Recurrent or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Evaluate the Incidence and Characteristics of Adverse Events of A-337 in the Treatment of malignant Solid Tumors

  Incidence and characteristics of adverse events

  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)

  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

  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

  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

  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

  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

  At the end of Cycle 3 (each cycle is 28 days)

Study Arms (1)

single arm

EXPERIMENTAL

A-337dosage: 0.05, 0.15, 0.3, 0.6, 0.9, 1.2, 1.5 μg/kg/d

Biological: Recombinant Anti-EpCAM-CD3 Antibody Injection

Interventions

Recombinant Anti-EpCAM-CD3 Antibody Injection BIOLOGICAL

Intravenous Infusion

single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ITabMed Co., Ltd.: lead

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qinghua Zhou, Doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darong Dai, Bachelor

CONTACT

8618284820495; darong.dai@itabmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share