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Advanced Solid TumorsPhase 1/2NCT07049458

Study of CHO-A04 in Advanced Solid Tumors

A Phase 1/2 study testing CHO-A04 in people with Advanced Solid Tumors, run by Cho Pharma Inc. at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
CHO-A04
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteTaiwan
Study dates
1 Jul 2027to 1 Jul 2029
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • Total bilirubin ≤ 1.5× ULN and no signs of jaundice (≤ 3× ULN for subjects with known Gilbert disease)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN or ≤ 5.0× ULN in case of documented hepatic metastasis or hepatocellular carcinoma (HCC). For subjects with HCC, the Child-Pugh score must be ≤ 6
  • Has adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2) Note: eGFR (mL/min/1.73 m2) = 186.3 × (serum creatinine in mg/dL)-1.154 × (age)-0.203× (0.742 if female) × (1.212 if African American/black)
  • Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions per Investigator's judgment
  • Is able to understand the nature of this clinical study and accepts to enter the study by signing the informed consent form (ICF)

Who cannot join

  • Has unresolved toxicities from prior anticancer therapy, defined as having not resolved to ≤ Grade 1 (NCI-CTCAE v5.0), except for alopecia and laboratory values listed in the inclusion criteria
  • 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
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  • 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.
  • Has participated in other clinical studies for investigational product(s) or medical device within 4 weeks or 5 half-lives (if known) prior to the planned first infusion, whichever is longer
  • Has received cell therapy within 12 weeks prior to the planned first infusion
  • Prior allogeneic hematopoietic stem cell, solid organ, or bone marrow transplantation(s)
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the planned first infusion and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of its clinical stability
  • Has symptomatic or poorly controlled pleural effusion, pericardial effusion, or ascites
  • With the following infections:
  • History of active pulmonary tuberculosis infection ≤ 48 weeks prior to the planned first infusion, regardless of tuberculosis treatment
  • Any major episode of infection requiring treatment with systemic antibiotics or hospitalization within 4 weeks prior to the planned first infusion
  • Positive HBsAg; subjects with positive HBsAg test results can be considered as eligible if subjects can receive anti-HBV viral treatment(s), e.g., entecavir or tenofovir
  • Positive anti-HCV; subjects with positive for anti-HCV but with negative results for HCV viremia as shown by PCR are considered as eligible.
  • Medical history showing confirmed HIV-1 positivity
  • Administration of a live, attenuated vaccine within 4 weeks prior to the planned first infusion or anticipation that such a live, attenuated vaccine will be required during the treatment period.
  • With known or suspected hypersensitivity to any ingredients of investigational product
  • History of severe allergic, anaphylactic, or other severe hypersensitivity reactions to therapeutic humanized antibodies
  • Female subject who is breastfeeding, has a positive pregnancy test result at eligibility checking, or expecting to conceive or have children within the projected duration of the trial, starting from the screening visit through 90 days after the last dose of study treatment.
  • All male subjects and female subjects with childbearing potential* (between puberty and 2 years after menopause) refuse to use at least two of appropriate contraception methods shown below from signing the ICF to at least 3 months after taking the last dose of study treatment.
  • Use oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
  • Male or female subjects who have undergone the following procedures are considered without childbearing potential.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 12 weeks before the screening visit. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (24 weeks prior to the first infusion).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tanny Tsao contact

+886-2-2655-8059

tanny.tsao@chopharma.com.tw

Taiwan1 site

  • Department of Oncology, National Taiwan University Hospital

    Taipei, 10002

    Tanny Tsao, +886-2-2665-8509, tanny.tsao@chopharma.com.tw

Other trials in Taiwan

About this study

Official title: A Phase I/IIa, Open-Label, Dose-Escalation and Cohort-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHO-A04 in Subjects With Advanced Solid Tumors

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?
Read more

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.

Read the detailed description

This Phase I/IIa, open-label, dose-escalation and cohort-expansion study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of CHO-A04 in subjects aged ≥ 18 years with advanced solid tumors.

Both Phases I and Phase IIa include a screening period of up to 4 weeks and study treatment once every week starting from Cycle 1 Day 1 (C1D1) until any treatment discontinuation criterion is met. Each treatment cycle of the study treatment is 28 days.

Subjects will receive intravenous (IV) infusion of CHO-A04 once a week for 4 weeks (D1, D8, D15, D22) as a treatment cycle. After the completion of last dose of the study treatment, subjects should complete the end-of-treatment (EOT) visit, safety follow-up (EOS) visit, and survival follow-up visits, unless withdrawn from this study.

  • Phase I (accelerated titration and traditional 3+3 dose-escalation): Phase I consists of the accelerated titration and the traditional 3+3 dose-escalation design. Eligible subjects will be sequentially assigned into one of the dose levels. Dose level will be escalated from dose level 1 (starting dose) at 1 mg/kg/week to dose level 5 at 12 mg/kg/week of CHO-A04 (or may be de-escalated to dose level -1 at 0.5 mg/kg/week). If any ≥ Grade 2 CHO-A04 related adverse events (AEs) occurs in dose level 1 or dose level 2 subjects, the dose escalation/de-escalation rule will follow the 3+3 design. Intra-subject dose-escalation is not allowed in this study.
  • Phase IIa (cohort-expansion): Two cohorts of up to 10 subjects per cohort will receive the Recommend Phase 2 Dose (R2PD), which is a dose equal to or lower than MTD based on the SRC's decision. The Sponsor will determine the cancer type for each cohort before initiation of Phase IIa.
Being tested
CHO-A04
Keywords
Advanced solid tumor, Anti-SSEA-4 antibody, Monoclonal antibody, Dose-escalation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHO-A04Drug

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

Study groups in NCT07049458
Study groupRoleWhat they receive
Phase I Dose Level -1: 0.5 mg/kg/weekExperimentalIntravenous infusion weekly
Receives: Drug: CHO-A04
Phase I Dose Level 1: 1 mg/kg/week [starting dose]ExperimentalIntravenous infusion weekly
Receives: Drug: CHO-A04
Phase I Dose Level 2: 2 mg/kg/weekExperimentalIntravenous infusion weekly
Receives: Drug: CHO-A04
Phase I Dose Level 3: 4 mg/kg/weekExperimentalIntravenous infusion weekly
Receives: Drug: CHO-A04
Phase I Dose Level 4: 8 mg/kg/weekExperimentalIntravenous infusion weekly
Receives: Drug: CHO-A04
Phase I Dose Level 5: 12 mg/kg/weekExperimentalIntravenous infusion weekly
Receives: Drug: CHO-A04
Phase IIa: RP2D for Cancer type AExperimentalRecommended 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
Receives: Drug: CHO-A04
Phase IIa: RP2D for Cancer type BExperimentalRecommended 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
Receives: Drug: CHO-A04

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 days after first dose (Cycle 1)

  2. 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.

    Measured: Up to 30 days after the last dose

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from the date of initial dosing until the first date of either disease progression or death due to any cause.

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

  2. Overall response rate (ORR)

    ORR will be calculated by combining subjects with complete response (CR) or partial response (PR) based on RECIST v1.1 criteria in best response.

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

  3. Disease control rate (DCR)

    DCR is defined as the percentage of subjects with at least one complete response (CR), partial response (PR) or stable disease (SD) per RECIST v1.1.

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

  4. Duration of response (DOR)

    DOR is defined as time from the date of the first documentation of partial response (PR) or complete response (CR) per RECIST v1.1 to the date of progression

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

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

    ECOG performance status is a scale used to assess how the disease affects the daily living abilities, and determine appropriate treatment and prognosis. It is a simple measure of functional status that determines ability of patient to tolerate therapies in cancer. The grading ranges from 0 (fully active, without performance restriction) to 5 (dead).

    Measured: Throughout the study till 4 weeks after the last dose

  6. Blood Concentration of CHO-A04

    The concentration of CHO-A04 in blood

    Measured: From day 1 pre-dosing, various time point after dosing and throughout the study till EOT follow-up (assessed up to 12 months)

  7. Anti-drug antibodies (ADAs) concentration

    The concentration of ADA in the blood

    Measured: Baseline, various time point during treatment period, and EOT follow-up (assessed up to 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start1 Jul 2027 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
* Phase I: accelerated titration and traditional 3+3 dose-escalation design * Phase II: cohort-expansion design
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07049458
Sponsor's protocol ID
CHO-A04-001
Status last verified
Oct 2026
First submitted
5 Jun 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CHO-A04 in people with Advanced Solid Tumors, run by Cho Pharma Inc. at 1 site in Taiwan.

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 20 inclusion and 39 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Tanny Tsao (+886-2-2655-8059, tanny.tsao@chopharma.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with dose-limiting toxicity (DLT) (time frame: Up to 28 days after first dose (Cycle 1)). 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?

On the ClinicalTrials.gov record for NCT07049458.

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 22 Oct 2026.

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Study of CHO-A04 in Advanced Solid Tumors | AzTrials