Study of CHO-A04 in Advanced Solid Tumors

NCT07049458 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CHO-A04-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the study drug, CHO-A04, works to treat solid cancers in adults. It will also aim to learn about the safety of CHO-A04 and find the best dose to use in future cancer treatment. The main questions it aims to answer are:

• Which dose of CHO-A04 shows the best anti-cancer ability?
• How will your body respond to CHO-A04 treatment?
• How long will CHO-A04 remain in your body? There are two stages of investigation in this study:
• Phase I: to find the best anti-cancer dose of CHO-A04
• Phase IIa: to find the CHO-A04 anti-cancer ability in specific cancer types In this study, each participant will be assigned to one of the CHO-A04 dose levels. Participants will have CHO-A04 infusion via blood vessel once every week for four weeks. The CHO-A04 treatment may continue based on participants' condition and CHO-A04 safety evaluations.

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumor; Anti-SSEA-4 antibody; Monoclonal antibody; Dose-escalation

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with dose-limiting toxicity (DLT)

  DLT is evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.The 5 general grades includes Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death.

  Up to 28 days after first dose (Cycle 1)

• Percentage of subjects occur with adverse events (AEs)

  Percentage of subjects with treatment-emergent adverse events (TEAEs), treatment-related adverse event (TRAEs), serious adverse events (SAEs), and infusion-related reactions (IRRs) will be measured. Severity grading will be assessed by the investigator based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. The 5 general grades includes Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death.

  Up to 30 days after the last dose

Secondary Outcomes (7)

• Progression-free survival (PFS)

  From first dose to disease progression or death, whichever occurs first, assessed up to 12 months

• Overall response rate (ORR)

  CT assessment every 2 cycles throughout the study till EOT follow-up

• Disease control rate (DCR)

  From first dose to confirmed disease progression, assessed up to 12 months

• Duration of response (DOR)

  From date of first documented response (CR or PR) to date of disease progression or death, assessed up to 12 months

• Change in Eastern Cooperative Oncology Group (ECOG) performance score from baseline

  Throughout the study till 4 weeks after the last dose

Study Arms (8)

Phase I Dose Level -1: 0.5 mg/kg/week

EXPERIMENTAL

Intravenous infusion weekly

Drug: CHO-A04

Phase I Dose Level 1: 1 mg/kg/week [starting dose]

EXPERIMENTAL

Intravenous infusion weekly

Drug: CHO-A04

Phase I Dose Level 2: 2 mg/kg/week

EXPERIMENTAL

Intravenous infusion weekly

Drug: CHO-A04

Phase I Dose Level 3: 4 mg/kg/week

EXPERIMENTAL

Intravenous infusion weekly

Drug: CHO-A04

Phase I Dose Level 4: 8 mg/kg/week

EXPERIMENTAL

Intravenous infusion weekly

Drug: CHO-A04

Phase I Dose Level 5: 12 mg/kg/week

EXPERIMENTAL

Intravenous infusion weekly

Drug: CHO-A04

Phase IIa: RP2D for Cancer type A

EXPERIMENTAL

Recommended Phase II dose (RP2D) level will be decided by Scientific Review Committee (SRC) based on accumulated study data in Phase I. Cancer type of each cohort will be determined before initiation of Phase IIa

Drug: CHO-A04

Phase IIa: RP2D for Cancer type B

EXPERIMENTAL

Recommended Phase II dose (RP2D) level will be decided by Scientific Review Committee (SRC) based on accumulated study data in Phase I. Cancer type of each cohort will be determined before initiation of Phase IIa

Drug: CHO-A04

Interventions

CHO-A04 DRUG

CHO-A04 will be given intravenously (IV) once weekly for 4 weeks as a treatment cycle.

Phase I Dose Level -1: 0.5 mg/kg/week; Phase I Dose Level 1: 1 mg/kg/week [starting dose]; Phase I Dose Level 2: 2 mg/kg/week; Phase I Dose Level 3: 4 mg/kg/week; Phase I Dose Level 4: 8 mg/kg/week; Phase I Dose Level 5: 12 mg/kg/week; Phase IIa: RP2D for Cancer type A; Phase IIa: RP2D for Cancer type B

Eligibility Criteria

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

You may qualify if:

• With either gender aged ≥ 18 years
• Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors
• Must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
• Availability of archival tissue specimens for SSEA-4 immunohistochemistry (IHC) staining (optional for Phase I). Acceptable tumor tissues include:
• Tumor tissue sample collected at the time of initial diagnosis
• The most recent available recurrent/metastatic tumor biopsy tissue is preferred if available (a pre-treatment biopsy is encouraged if the biopsy site is safely accessible) Note: This criterion is fulfilled if there is a qualified tumor sample (tumor cells were presented in the tumor biopsy tissue) and the tumor tissue slides can be obtained for IHC staining. It is not violated even if the staining result obtained after the screening visit reveals that the slides contain no identifiable tumor cells.
• Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
• Has a life expectancy of at least 12 weeks in the opinion of the Investigator
• Has adequate hematopoietic function:
• Absolute neutrophil count (ANC) ≥ 1500 cells/μL without the need of myeloid growth factor support within 1 week
• Platelet ≥ 90×103 counts/μL without the need of platelet transfusion support within 1 week
• Hemoglobin ≥ 9.0 g/dL without the need of red blood cell (RBC) transfusion within 1 week
• Has adequate coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× upper limit of the normal range (ULN)
• Has adequate liver function:

You may not qualify if:

• Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s), or any severe concomitant conditions which, in the Investigator's opinion, make it undesirable for the subject to participate in the study, or could jeopardize compliance with the protocol
• History of another primary malignancy within the last 3 years (except for treated basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, or in situ cancer of the cervix) prior to the planned first infusion
• Has any significant cardiovascular or pulmonary diseases, including:
• Poorly controlled hypertension (systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥ 100 mm Hg)
• Left ventricular ejection fraction (LVEF) \< 50% at the screening visit
• Congestive heart failure (defined as New York Heart Association Class III or IV), myocarditis, myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, or coronary artery bypass graft within 24 weeks prior to the planned first infusion
• Uncontrolled serious cardiac arrhythmias, such as ongoing clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes) Note: Sustained ventricular tachycardia is defined as tachycardia that continues for more than 30 seconds or leads to hemodynamic compromise within 30 seconds and requires intervention
• Corrected QT interval (QTcF) \> 480 ms demonstrated by at least two 12-lead ECGs \> 30 minutes apart
• Evidence of active pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or history of idiopathic pulmonary fibrosis. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• History of 2nd or 3rd-degree atrioventricular conduction defects
• History of thromboembolic or cerebrovascular events within the last 24 weeks before the screening visit, including transient ischemic attack, cerebrovascular accident, or deep vein thrombosis
• Has other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would make the subject inappropriate for enrollment in this study in the opinion of the Investigator
• Has received anti-cancer therapies such as surgery on target lesions, chemotherapy, small molecule agent(s), hormone therapy, radiation therapy (except for palliative radiotherapy for bone metastasis of non-skeletal tumors), or any other anti-cancer agent(s) within 4 weeks or 5 half-lives of the treated agents, whichever is longer, prior to the first dosing. Has received prior anti-cancer monoclonal antibody therapy within 8 weeks prior to the first infusion.
• Has received systemic immunosuppressive medication(s) (including, but not limited to, steroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, tumor necrosis factor-ɑ antagonists, and calcineurin inhibitors) within 2 weeks (for those with a half-life ≤ 72 hours) or 4 weeks (for those half-life \> 72 hours) prior to study dosing.
• Note: For regular steroid use, ≤ 10 mg of prednisolone per day or equivalent is allowed. Inhaled or topical corticosteroids are allowed.

Sponsors & Collaborators

• Cho Pharma Inc.: lead

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Study Officials

• Chia-Chi (Josh) Lin, M.D., PhD.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanny Tsao

CONTACT

+886-2-2655-8059; tanny.tsao@chopharma.com.tw

Study Design

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

Model Details: * Phase I: accelerated titration and traditional 3+3 dose-escalation design * Phase II: cohort-expansion design

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)