A Clinical Trial to Evaluate the Effect of IAE0972 in Patients With Advanced Malignant Solid Tumors.

NCT05396339 | Unknown Phase 1 FDA Drug

• 1 other identifier: IAE0972-I/IIa
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors.

Conditions

Advanced Malignant Solid Tumor

Keywords

EGFR; IL10; Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of IAE0972 in Phase I

  MTD/R2PD ,Incidence and frequency of DTL; AE，SAE occurrence and frequency (according to NCI CTCAE 5.0)

  28 days after last medication, an average of 1 year

• Objective response rate (ORR) in Phase IIa

  To explore the effectiveness of IAE0972.

  Baeline until disease progression, assessed up to 36 months

Secondary Outcomes (26)

• Pharmacokinetic (PK) Cmax

  after single dose , an average of 1 year

• Pharmacokinetic (PK) Css,max

  after multiple doses , an average of 1 year

• Pharmacokinetic (PK) Css,min

  after multiple doses , an average of 1 year

• Pharmacokinetic (PK) Css,av

  after multiple doses , an average of 1 year

• Pharmacokinetic (PK) AUCss

  after multiple doses , an average of 1 year

Study Arms (4)

Phase Ia - Dose escalation(Acceleration Stage)

EXPERIMENTAL

Phase Ia is an open, non-random, single-arm dose escalation design.

Drug: IAE0972

Phase Ia - Dose escalation(3+3 Stage)

EXPERIMENTAL

Phase Ia is an open, non-random, single-arm dose escalation design.

Drug: IAE0972

Phase Ib - Dose extension

EXPERIMENTAL

Phase Ib is an open, non-random, single-arm, multi-center research design.

Drug: IAE0972

Phase IIa - Clinical Exploratory Stage

EXPERIMENTAL

The Phase IIa is planned to be divided into three indication groups, all of which are open, non-randomized, single-arm research design.

Drug: IAE0972

Interventions

IAE0972 DRUG

IAE0972 is an investigational product

Phase IIa - Clinical Exploratory Stage; Phase Ia - Dose escalation(3+3 Stage); Phase Ia - Dose escalation(Acceleration Stage); Phase Ib - Dose extension

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
• \. Male or female, of any race, aged between 18 years and 80 years; 3. With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either refractory to standard therapy or for which no effective therapy was available.
• \. Measurable disease as determined by RECIST version 1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy ≥ 12 weeks. 7. Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1 (with exception of ≤ Grade 2 alopecia, stable sensory neuropathy, or stable electrolyte disturbances that are managed by supplementation).
• \. Acceptable laboratory parameters as follows:
• Platelet count (PLT) ≥ 90 × 109/L without transfusion within 2 weeks prior to the initiation of investigational product.
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L in the absence of any growth factor support within 2 weeks prior to the initiation of investigational product.
• International normalized ratio of prothrombin time (INR) ≤ 1.5 × upper limit of normal (ULN), activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
• Hemoglobin (HGB) ≥ 90 g/L.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; for patients with hepatic metastases, ALT and AST ≤ 5.0 × ULN.
• Total bilirubin ≤ 1.5 × ULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin is within normal limits.
• Serum creatinine \< 1.5 × ULN, or estimated creatinine clearance ≥ 60 mL/min as measured or calculated using the Cockcroft-Gault formula.
• \. Female patients of childbearing potential (not surgically sterilized and between menarche and 1- year postmenopause) must have a negative serum or urine pregnancy test performed within 7 days prior to the initiation of investigational product administration. Further, female patients of childbearing potential must agree to use highly effective contraceptive measures (include hormonal contraceptives, intrauterine device or system, vasectomy, or tubal ligation) from the time of consent through 3 months after discontinuation of investigational product administration.
• \. Male patients with partners of childbearing potential must use barrier contraception. In addition, male patients should also have their partners use another method of contraception from the time of consent through 3 months after discontinuation of investigational product administration.

You may not qualify if:

• \. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IAE0972.
• \. History of another malignancy or a concurrent malignancy. Exceptions include patients who have been disease free for two years, or successfully treated for non-melanoma skin cancer, localized prostate cancer (Gleason Score \< 6) or carcinoma in situ, for example cervical cancer in situ, are eligible.
• \. Treatment with any systemic anti-neoplastic therapy, radiation therapy or investigational therapy within 4 weeks prior to the initiation of investigational product administration, with the following exceptions:
• Nitrosourea or mitomycin C should be within 6 weeks prior to the initiation of investigational product administration.
• Oral fluoropyrimidines and small molecule targeted drugs should be within 2 weeks or 5 half-lives (whichever is later) prior to the initiation of investigational product administration.
• \. History of trauma or major surgery within 4 weeks prior to the initiation of investigational product administration.
• \. Treatment with corticosteroids (prednisone ≥ 10 mg per day or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of investigational product administration. Steroids for topical, ophthalmic, inhaled or nasal administration are allowed.
• \. Treatment with immunomodulatory agents, including but not limited to thymosin, interleukin-2 and interferon within 14 days prior to the initiation of investigational product administration.
• \. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.
• \. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
• \. Active brain or leptomeningeal metastases. Patients with brain metastases are eligible if these have been treated and MRI or CT shows no evidence of progression for at least 8 weeks after treatment completion and within 4 weeks prior to the initiation of investigational product. Patients are not eligible if they required high doses of systemic corticosteroids that could result in immunosuppression (\>10 mg/day prednisone equivalents) for at least 2 weeks prior to the initiation of investigational product.
• \. Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of investigational product. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of investigational product.
• \. Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR).
• \. Known positive testing for human immunodeficiency virus (HIV) or history of acquired immune deficiency syndrome (AIDS).
• \. Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.

Sponsors & Collaborators

• SUNHO（China）BioPharmaceutical CO., Ltd.: lead

Study Sites (2)

Affilated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Study Officials

• Jin Li, M.D.

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

• Yuping Sun, M.D.

  Affilated Cancer Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minwei Manager

CONTACT

18068131816; shenminwei@sunho-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: June 24, 2022
• Primary Completion: May 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)