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Tests treatment safety and results for Locally Advanced or Metastatic Solid Tumors
Official title 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
ClinicalTrials.gov ID: NCT05473156
What this study is testing
What is AP203?
AP203 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Dose escalation Phase and Dose expansion Phase
- Written informed consent by the participants or the participant's legally authorized representative prior to screening.
- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at...
- Disease must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions situated in a...
- Participants with adequate organ function defined by the following: Participants must not have required blood transfusion or growth factor support ≤...
You likely can't join if
- Participants who have received concurrent antitumor treatment or investigational products within 28 days or 5 half lives, whichever is shorter before...
- Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).
- 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...
- Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
- Participants with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the...
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time...
See the full eligibility criteria
Who can join
- Dose escalation Phase and Dose expansion Phase
- Written informed consent by the participants or the participant's legally authorized representative prior to screening.
- 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.
- 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...
- 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:
- Absolute neutrophil count ≥ 1.5 × 109 /L.
- Platelet count ≥ 100 × 109 /L.
- Hemoglobin ≥ 9 g/dL.
- Alanine aminotransferase and AST ≤ 2.5 × ULN or \< 5 × ULN if hepatic metastases present.
- Serum total bilirubin ≤ 1.5 × ULN (or \< 3 × ULN for participants with Gilbert's syndrome).
- Alkaline phosphatase ≤ 2.5 × ULN or \< 5 × ULN if bone metastases present.
- Prothrombin time ≤ 1.5 × ULN.
- 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.
- Estimated creatinine clearance \> 50 mL/min according to the Cockcroft Gault formula
- 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:
- 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
- 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...
- Only participants who have evaluable PD L1 expression results are eligible.
- 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.
- 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.
- 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
What rules you out
- 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...
- Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).
- 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.
- Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
- 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...
- 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...
- Participants who received any organ transplantation including allogeneic stem cell transplantation.
- Participants with significant acute or chronic infections including, among others: o Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)...
- 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...
- Participants with known severe hypersensitivity reactions to monoclonal antibodies.
- Participants with pregnancy or lactation period. (Note: a negative pregnancy test is required for WOCBP.)
- Participants with known alcohol or drug abuse.
- 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...
- Participants with any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Participants with live vaccination within 28 days of the first dose of AP203 and while on study is prohibited.
- 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:
- Participants who have received prior therapy with any PD-L1 x CD137 bispecific antibody.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.