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Locally Advanced or Metastatic Solid TumorsPhase 1/2APT-CUBENCT05473156

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

A Phase 1/2 study testing AP203 in people with Locally Advanced or Metastatic Solid Tumors and Non Small Cell Lung Cancer (NSCLC), run by AP Biosciences Inc. at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AP203
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteTaiwan
Study dates
24 Jul 2023to Dec 2027
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
  • Dose escalation Phase and Dose expansion Phase Inclusion Criteria:
  1. Written informed consent by the participants or the participant's legally authorized representative prior to screening.
  2. Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.
  3. Disease must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions situated in a previously irradiated area are not considered measurable unless there has been demonstrated progression in the lesion. Imaging tests outside the screening period are valid if performed not more than 2 weeks before consent signature and otherwise fulfil protocol criteria.
  4. Participants with adequate organ function defined by the following: Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening:
  5. Absolute neutrophil count ≥ 1.5 × 109 /L.
  6. Platelet count ≥ 100 × 109 /L.
  7. Hemoglobin ≥ 9 g/dL.
  8. Alanine aminotransferase and AST ≤ 2.5 × ULN or < 5 × ULN if hepatic metastases present.
  9. Serum total bilirubin ≤ 1.5 × ULN (or < 3 × ULN for participants with Gilbert's syndrome).
  10. Alkaline phosphatase ≤ 2.5 × ULN or < 5 × ULN if bone metastases present.
  11. Prothrombin time ≤ 1.5 × ULN.
  12. International normalized ratio (INR) ≤ 2.0 or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 is acceptable for participants on a stable dose of anticoagulants.
  13. Estimated creatinine clearance > 50 mL/min according to the Cockcroft Gault formula
  14. Participants with highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists.
  • Dose escalation Phase specific Inclusion Criterion:
  1. Participants with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors, which are refractory or intolerant to standard therapy or for which no standard therapy exists.
  • Dose expansion Phase specific Inclusion Criteria:
  1. Participants who have histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic NSCLC, HNSCC, ESCC, who received at least one line of systemic treatment including anti-PD-1 or anti-PD-L1 therapy.
  2. Only participants who have evaluable PD L1 expression results are eligible.
  3. NSCLC cohort:
  • Documented histologically or cytologically squamous or non-squamous stage IV NSCLC.
  • Documented evidence of tumors expressing PD L1 (TPS ≥ 1%) for the determination of PD L1 expression in NSCLC.
  • No sensitive epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement.
  • No known actionable genomic alterations of ROS1 rearrangement, BRAF V600E mutation, MET mutation, NTRK1/2/3 gene fusion, and/or RET rearrangement.
  1. HNSCC cohort:
  • Documented histologically or cytologically squamous cell carcinoma of the head and neck. Nasopharynx is excluded.
  • Refractory or intolerant to platinum based chemotherapy or concurrent chemoradiation.
  • PD L1 expression: Documented evidence of Combined Positive Score (CPS) ≥ 1 for PD L1.
  1. ESCC cohort:
  • Documented histologically or cytologically squamous carcinoma.
  • PD L1 expression: Documented evidence of CPS ≥ 1 for PD L1.
  • Dose escalation Phase and Dose expansion Phase Exclusion Criteria:
  1. Participants who have received concurrent antitumor treatment or investigational products within 28 days or 5 half lives, whichever is shorter before the start of study intervention (e.g., chemotherapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin).
  2. Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).
  3. Participants who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, < Grade 2 sensory neuropathy.
  4. Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
  5. Participants with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the exception of resected basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
  6. Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:
  7. Brain imaging at screening shows no evidence of interim progression, participant is clinically stable for at least 2 weeks and without evidence of new brain metastases.
  8. Measurable disease outside the CNS. c. No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 2 weeks before the first dose of AP203; anticonvulsants at a stable dose are allowed.
  9. Participants who received any organ transplantation including allogeneic stem cell transplantation.
  10. Participants with significant acute or chronic infections including, among others:
  • Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Note: An HIV serology test (including antigen and/or antibodies) will be conducted at baseline for the participants with unknown HIV status and participants with positive HIV test will be excluded.
  • Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV deoxyribonucleic acid (DNA) > 500 IU/mL (or > 2500 copies/mL) at screening. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Participants with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Participants receiving antivirals at screening should have been treated for > 2 weeks before the first dose of AP203.
  • Participants with active hepatitis C. Note: Participants with a negative hepatitis C virus (HCV) antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening are eligible. The HCV RNA test will be performed only for participants testing positive for HCV antibody. Participants receiving antivirals at screening should have been treated for > 2 weeks before the first dose of AP203.
  1. Participants with active or history of any autoimmune disease that may relapse (participants with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
  2. Participants with known severe hypersensitivity reactions to monoclonal antibodies.
  3. Participants with pregnancy or lactation period. (Note: a negative pregnancy test is required for WOCBP.)
  4. Participants with known alcohol or drug abuse.
  5. Participants with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to the first dose of AP203), myocardial infarction (< 6 months prior to the first dose of AP203), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.
  6. Participants with any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  7. Participants with live vaccination within 28 days of the first dose of AP203 and while on study is prohibited.
  8. Participants with all other significant diseases, in the opinion of the Investigator, might impair the participant's tolerance of the study intervention.
  • Dose expansion Phase specific Exclusion Criterion:
  1. Participants who have received prior therapy with any PD-L1 x CD137 bispecific antibody.

Trial locations and contacts

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

Ya Shen contact

+886-2-2653-2886#117

yashen@apbioinc.com

Taiwan1 site, 1 recruiting

  • AP Biosciences Inc.

    Taipei, 115011

    Project Manager, +886-2-2653-2886#117, yashen@apbioinc.com

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase 1/2, Open-label Study of the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid tumors.

Being tested
AP203
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • AP203Drug

    Eight dose levels ranging from 0.00064 to 20 mg/kg will be evaluated to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) or the recommended phase 2 dose(s) (RP2D[s]).

    Participants will be administered by intravenous (IV) infusion, every week (Q1W [± 1days]) for the first 3 weeks (from the first to the fourth dose), then administered every 2 weeks (Q2W [± 3 days]) for all the following doses.

  • AP203Drug

    The dose-expansion phase will be conducted following completion of dose escalation for AP203. Participants will receive AP203 by IV infusion, administered Q1W (± 1 days) for the first 3 weeks (from the first to the fourth dose), then administered Q2W (± 3 days) for all the following doses, at the RP2D for each expansion cohort.

Study groups in NCT05473156
Study groupRoleWhat they receive
Dose-EscalationExperimentalNot described
Receives: Drug: AP203
Dose-Expansion (Non Small Cell Lung Cancer, NSCLC)ExperimentalNot described
Receives: Drug: AP203
Dose-Expansion (Head and Neck Squamous Cell Carcinoma, HNSCC)ExperimentalNot described
Receives: Drug: AP203
Dose-Expansion (Esophageal Squamous Cell Carcinoma, ESCC)ExperimentalNot described
Receives: Drug: AP203

What is being measured

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

  1. Dose-Escalation: Number of Participants With Dose Limiting Toxicity (DLT)

    DLT is defined as toxicity (adverse event [AE] at least possibly related to AP203) occurring during the DLT evaluation period

    Measured: The initial 28 days and completion of the first 4 doses of treatment

  2. Both Dose-Escalation and Dose-Expansion: Number of Participants With Adverse Events (AEs) and Serious AEs

    Safety assessed using incidence, nature, and severity of AEs and SAEs

    Measured: At screening (≤ 28 days before the first dose of AP203), up to 90 days after the last dose

  3. Dose-Expansion: Overall response rate(ORR) (assessed by the Investigator according to RECIST version 1.1)

    ORR is defined as the proportion of participants with CR or PR

    Measured: At screening (≤ 28 days before the first dose of AP203, up to 90 days after the last dose

Timeline

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

  1. First posted25 Jul 2022
  2. Study start24 Jul 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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
Parallel groups
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473156
Sponsor's protocol ID
AP203-101
Acronym
APT-CUBE
Status last verified
Mar 2025
First submitted
20 Jul 2022
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AP203 in people with Locally Advanced or Metastatic Solid Tumors and Non Small Cell Lung Cancer (NSCLC), run by AP Biosciences 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?

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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 Ya Shen (+886-2-2653-2886#117, yashen@apbioinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Escalation: Number of Participants With Dose Limiting Toxicity (DLT) (time frame: The initial 28 days and completion of the first 4 doses of treatment). The study lists 3 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 NCT05473156.

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 26 Mar 2025.

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