Advanced Solid TumorsPhase 1NCT06723964
A Study of AP505 Injection in Patients With Advanced Malignant Solid Tumors
A Phase 1 study testing AP505 in people with Advanced Solid Tumors, run by AP Biosciences Inc. at 1 site in Taiwan.
Trial summary
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of AP505 injection in patients with advanced solid tumors. The study will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for AP505. 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?
- AP505
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Mar 2023to 30 Nov 2025
- Phase
- Phase 1
- 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
- In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- Voluntarily participate in this study and provide a signed and dated informed consent form (ICF).
- Male or female aged ≥ 18 years old (inclusive) at the time of signing the ICF.
- Patients with histologically and/or cytologically confirmed advanced solid tumor, who have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds, or refused to standard treatment (late or last line). Note: for subjects who are eligible based on intolerance to standard therapy or considered ineligible for standard therapies in the opinion of the investigator, the basis of this determination should be captured in the case report forms.
- Willing to comply with the visits, study treatment, laboratory examinations and other study-related procedures and requirements specified in the study protocol.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
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- Expected survival time of more than 3 months.
- Have at least one measurable lesion per RECIST version 1.1.
- Adequate organ and bone marrow function:
- Hematology (no blood transfusion, no G-CSF, no medication correction within 2 weeks prior to screening): Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet (PLT) ≥ 100×109/L, hemoglobin (Hb) ≥ 90 g/L.
- Liver function: total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0×ULN, aspartate aminotransferase (AST) ≤ 3.0×ULN; for patients with liver metastases: ALT ≤ 5.0×ULN, AST ≤ 5.0×ULN;
- Renal function: creatinine clearance (CrCL) ≥ 50 mL/min (calculated according to Cockcroft-Gault formula);
- Coagulation function: prothrombin time (PT) ≤ 1.5×ULN or international normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- For female patients:
- Females of childbearing potential who are not breastfeeding must agree to use highly effective contraceptives from the time of signing the ICF and use such contraceptives during the study and for at least 6 months after the last dose of the study drug; The blood pregnancy test result (human chorionic gonadotropin, hCG) must be negative within 3 days prior to enrollment.
- Women who are infertile (i.e., physiologically incapable of becoming pregnant), including those surgically sterilized (having undergone bilateral oophorectomy, bilateral tubal ligation, or hysterectomy), or postmenopausal (non-treatment-induced amenorrhea) for ≥ 12 months prior to screening.
- For male patients with fertile female partners, they must agree to use high-efficiency contraception from the time of signing the ICF and to use such contraception during the study and for at least 6 months after the last dose of the study drug.
Who cannot join
- In order to participate in this study, all subjects must meet NONE of the exclusion criteria described.
- Have received immune checkpoint inhibitors (ICIs) such as anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, or VEGF inhibitor such as bevacizumab, ramucirumab, apatinib, or regorafenib within 28 days prior to the first dose of the study drug.
- Known hypersensitivity to the study drug and any of its components; or known history of previous severe allergic reactions to macromolecular protein preparations/monoclonal antibodies or bispecific antibodies.
- Female patient who is pregnant or breastfeeding.
- Received major surgery within 4 weeks prior to the first dose of the study drug or requiring major elective surgery during the study period.
- The adverse reactions caused by previous anti-tumor therapy have not been recovered to ≤ grade 1 per NCI CTCAE v5.0 (except for alopecia).
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- Subjects with untreated or symptomatic brain metastases, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastases (Exception: Treated and stable symptoms, stable imaging for at least 4 weeks prior to first dose, with no evidence of cerebral edema, and no need for glucocorticoid therapy).
- Patients with pleural effusion, pericardial effusion or ascites that have shown clinical symptoms or requiring repeated drainage.
- Imaging during the screening period showed that the tumor surrounded important blood vessels or the presence of obvious tumor necrosis and cavitation, and the Investigator judged that entering the study may cause bleeding risk.
- Known history of human immunodeficiency virus (HIV) infection (positive for HIV 1/2 antibody test) or diseases related to acquired immunodeficiency syndrome (AIDS).
- Patients with hepatitis B infection undergoing treatment or requiring treatment (defined as hepatitis B surface antigen (HBsAg) positive, and HBV DNA >1000 copies/mL (200IU/mL) or above the lower limit of the detection, whichever is higher); or patients with hepatitis C antibody (HCV-Ab) positive and HCVRNA quantification > the upper limit of normal of the testing unit; or patients with known active syphilis infection.
- Patients with uncontrolled bacterial, viral, fungal infections, or other pathogen infections (such as mycoplasma, parasites, etc.) that need systemic treatment within 4 weeks prior to the first dose of the study drug.
- Known history of serious cardiovascular disease, including but not limited to:
- Ventricular arrhythmia requiring clinical intervention.
- Acute coronary syndrome (myocardial infarction and angina pectoris) within 6 months prior to the first dose of the study drug.
- Congestive heart failure (New York Heart Association (NYHA) class ≥ II) or left ventricular ejection fraction (LVEF) < 50%;
- QTc > 470 msec
- Uncontrolled hypertension (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90 mmHg) after standard of care or poor compliance to antihypertensive therapy.
- Major vascular disease (e.g., aortic aneurysm requiring surgery).
- Patients with coagulation disorders, bleeding disorders, or other conditions having bleeding risk as judged by the Investigator, such as: skin wounds, surgical sites, trauma sites, mucosal severe ulcers or fractures that are not completely healed, or active gastroduodenal ulcer, intestinal obstruction, ulcerative colitis, esophagogastric varices, gastrointestinal perforation, etc. within 6 months before the first dose of the study drug.
- Patients with ≥ grade 2 pulmonary hemorrhage/hemoptysis (according to NCI-CTCAE v5.0) within 1 month before the first dose of the study drug.
- Patients with biopsy or other minor surgery within 7 days before the first dose of the study drug, except for placement of vascular access devices.
- Patients experiencing arterial or venous thrombosis, stroke, or transient ischemic attack within 6 months before the first dose of the study drug.
- Have received unstable doses of anticoagulant or thrombolytic drugs within 14 days of the first dose of the study drug. Please note that prophylactic use of low molecular weight heparin is allowed in the study.
- Have received chronic treatment with aspirin (> 325 mg/day) or non-steroidal anti-inflammatory drugs known to inhibit platelet function; or received dipyridamole, ticlopidine, clopidogrel, or cilostazol within 14 days of first dose of the study drug.
- Patients with diabetes mellitus poorly controlled by standard therapy (glycated hemoglobin HbA1c >8%).
- Patients with current or past idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except for local interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, etc.; Severe breathing difficulties, pulmonary insufficiency, or continuous oxygen inhalation.
- Patients with active autoimmune disease, or history of autoimmune disease requiring systemic treatment within 2 years prior to screening, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with the following conditions are eligible: hypothyroidism that can be controlled by hormone replacement therapy only, skin diseases (eg, vitiligo, psoriasis) that do not require systemic treatment, controlled celiac disease.
- Received systemic corticosteroid treatment (prednisone > 10 mg/day or equivalent dose of similar drugs) or other systemic immunosuppressive treatment within 14 days before the first dose of the study drug.
- Patients with the following conditions are permitted: Treatment with topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; OR prophylactic short-term (≤ 7 days) use of corticosteroids (eg, hypersensitivity to contrast agent)); OR for the treatment of nonautoimmune diseases (such as delayed hypersensitivity reactions caused by contact allergens).
- Received systemic antitumor therapy (chemotherapy, targeted therapy, biologic therapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study treatment; Received small molecule tyrosine kinase inhibitor therapy or hormonal antitumor therapy within 2 weeks before the first dose; received non-specific immunomodulatory therapy within 2 weeks before the first dose (such as interleukin, interferon, thymosin, cyclophosphamide, methotrexate, thalidomide, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia); received Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 1 week before the first dose of the study drug.
- For patients with hepatocellular carcinoma: Received locoregional treatment of the liver (such as transarterial chemoembolization, transcatheter embolization, hepatic arterial infusion, radiotherapy, radioembolization, or ablation) within 4 weeks prior to the first dose of the study drug.
- Previously received organ or hematopoietic stem cell transplantation requiring the use of immunosuppressive agents.
- History of other tumors within 5 years before screening, excluding skin basal cell carcinoma, skin squamous cell carcinoma, and cervical carcinoma in situ who underwent successful radical resection.
- Received an attenuated vaccine within 4 weeks before screening or planned to receive an attenuated vaccine during the study.
- Patients who participated in other clinical study and received other investigational agents or treatment within 4 weeks or 5 half-lives (whichever is longer) before the first dose of the study drug.
- History of alcohol or drug abuse within 12 months prior to the first dose (for patients diagnosed with drug or alcohol abuse prior to 12 months prior to first dose, Enrollment only if no evidence of actual drug or alcohol abuse within 12 months prior to first dose).
- Patient with any other medical or psychological condition, that is deemed by the Investigator to be likely to interfere with his/her ability to sign the informed consent, cooperate, or participate in the study.
- Patients with other serious systemic diseases or conditions who are deemed unsuitable to participate in this clinical study at the judgement of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Dose-Escalation Study to Evaluate the Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of AP505 Injection, an Anti-PD-L1 and Anti-VEGF Bispecific Antibody, in Patients With Advanced Solid Tumors
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of AP505 injection in patients with advanced solid tumors. The study will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for AP505.
- Conditions
- Advanced Solid Tumors
- Being tested
- AP505
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP505Drug
AP505 is a Anti-PD-L1 and Anti-VEGF Antibody Fusion Protein.
| Study group | Role | What they receive |
|---|---|---|
| AP505 0.035 mg/kg | Experimental | AP505 0.035 mg/kg Open Label Receives: Drug: AP505 |
| AP505 0.12 mg/kg | Experimental | AP505 0.12 mg/kg Open Label Receives: Drug: AP505 |
| AP505 0.4 mg/kg | Experimental | AP505 0.4 mg/kg Open Label Receives: Drug: AP505 |
| AP505 1.2 mg/kg | Experimental | AP505 1.2 mg/kg Open Label Receives: Drug: AP505 |
| AP505 4.0 mg/kg | Experimental | AP505 4.0 mg/kg Open Label Receives: Drug: AP505 |
| AP505 8.0 mg/kg | Experimental | AP505 8.0 mg/kg Open Label Receives: Drug: AP505 |
| AP505 11.0 mg/kg | Experimental | AP505 11.0 mg/kg Open Label Receives: Drug: AP505 |
| AP505 15.0 mg/kg | Experimental | AP505 15.0 mg/kg Open Label Receives: Drug: AP505 |
| AP505 20.0 mg/kg | Experimental | AP505 20.0 mg/kg Open Label Receives: Drug: AP505 |
| AP505 25.0 mg/kg | Experimental | AP505 25.0 mg/kg Open Label Receives: Drug: AP505 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Escalation : DLT Assessment
Number of Participants With Dose Limiting Toxicity (DLT)
Measured: From Day1 to Day15 after first dose of AP505
AE Assessment
All AEs and SAEs will be collected, regardless of the relationship to the IP.
Measured: From screening to follow-up period which includes safety follow-up (30/60/90 days after last dose) and survival follow-up (every 3 months until subject loss to follow-up, death, withdrawal of consent, or study termination, whichever occurs first).
Determine the maximum tolerated dose (MTD)
Measured: From first dose of AP505 until 28 days after the last dose of AP505
Determine the recommended phase II dose (RP2D)
Measured: From first dose of AP505 until 28 days after the last dose of AP505
Secondary outcomes (6)
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Peak Plasma Concentration (Cmax) Analysis
Measured: From C1D1 until 7 days after treatment discontinuation/ termination.
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Area under the plasma concentration versus time curve (AUC) Analysis
Measured: From first dose until 7 days after treatment discontinuation/ termination.
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Terminal elimination half-life (t1/2) Analysis
Measured: From first dose until 7 days after treatment discontinuation/ termination.
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Time to reach the maximum observed concentration (Tmax) Analysis
Measured: From first dose until 7 days after treatment discontinuation/ termination
To characterize the immunogenicity profile of AP505 in patients with advanced solid tumors
Immunogenicity indicators: the level of anti-drug antibody (ADA).
Measured: From C1D1 (Cycle 1 is 15 days ; Cycle 2 onwards: each cycle is 28 days), until safety follow up (up to 90 days after the last dose).
To characterize the immunogenicity profile of AP505 in patients with advanced solid tumors
Immunogenicity indicators: the level of NAb (if ADA is positive).
Measured: From C1D1 (Cycle 1 is 15 days ; Cycle 2 onwards: each cycle is 28 days), until safety follow up (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.
- First posted9 Dec 2024
- Study start30 Mar 2023
- Primary completion31 Oct 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AP Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723964
- Sponsor's protocol ID
- AP505-101
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study to Evaluate the Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of AP505 Injection, an Anti-PD-L1 and Anti-VEGF Bispecific Antibody, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06723964
- Acronym / sponsor ID
- AP505-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AP Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of AP505 injection in patients with advanced solid tumors. The study will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for AP505.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| AP505 0.035 mg/kg | Experimental | Drug: AP505AP505 0.035 mg/kg Open Label |
| AP505 0.12 mg/kg | Experimental | Drug: AP505AP505 0.12 mg/kg Open Label |
| AP505 0.4 mg/kg | Experimental | Drug: AP505AP505 0.4 mg/kg Open Label |
| AP505 1.2 mg/kg | Experimental | Drug: AP505AP505 1.2 mg/kg Open Label |
| AP505 4.0 mg/kg | Experimental | Drug: AP505AP505 4.0 mg/kg Open Label |
| AP505 8.0 mg/kg | Experimental | Drug: AP505AP505 8.0 mg/kg Open Label |
| AP505 11.0 mg/kg | Experimental | Drug: AP505AP505 11.0 mg/kg Open Label |
| AP505 15.0 mg/kg | Experimental | Drug: AP505AP505 15.0 mg/kg Open Label |
| AP505 20.0 mg/kg | Experimental | Drug: AP505AP505 20.0 mg/kg Open Label |
| AP505 25.0 mg/kg | Experimental | Drug: AP505AP505 25.0 mg/kg Open Label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- Voluntarily participate in this study and provide a signed and dated informed consent form (ICF).
- Male or female aged ≥ 18 years old (inclusive) at the time of signing the ICF.
- Patients with histologically and/or cytologically confirmed advanced solid tumor, who have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds, or refused to standard treatment (late or last line). Note: for subjects who are eligible based on intolerance to standard therapy or considered ineligible for standard therapies in the opinion of the investigator, the basis of this determination should be captured in the case report forms.
- Willing to comply with the visits, study treatment, laboratory examinations and other study-related procedures and requirements specified in the study protocol.
Key exclusion criteria (39 listed)
- In order to participate in this study, all subjects must meet NONE of the exclusion criteria described.
- Have received immune checkpoint inhibitors (ICIs) such as anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, or VEGF inhibitor such as bevacizumab, ramucirumab, apatinib, or regorafenib within 28 days prior to the first dose of the study drug.
- Known hypersensitivity to the study drug and any of its components; or known history of previous severe allergic reactions to macromolecular protein preparations/monoclonal antibodies or bispecific antibodies.
- Female patient who is pregnant or breastfeeding.
- Received major surgery within 4 weeks prior to the first dose of the study drug or requiring major elective surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP505AP505 is a Anti-PD-L1 and Anti-VEGF Antibody Fusion Protein. | Drug | AP505 0.035 mg/kg, AP505 0.12 mg/kg, AP505 0.4 mg/kg, AP505 1.2 mg/kg, AP505 11.0 mg/kg, AP505 15.0 mg/kg, AP505 20.0 mg/kg, AP505 25.0 mg/kg, AP505 4.0 mg/kg, AP505 8.0 mg/kg |
Primary outcome
Dose-Escalation : DLT Assessment
Time frame: From Day1 to Day15 after first dose of AP505
Number of Participants With Dose Limiting Toxicity (DLT)
AE Assessment
Time frame: From screening to follow-up period which includes safety follow-up (30/60/90 days after last dose) and survival follow-up (every 3 months until subject loss to follow-up, death, withdrawal of consent, or study termination, whichever occurs first).
All AEs and SAEs will be collected, regardless of the relationship to the IP.
Determine the maximum tolerated dose (MTD)
Time frame: From first dose of AP505 until 28 days after the last dose of AP505
Determine the recommended phase II dose (RP2D)
Time frame: From first dose of AP505 until 28 days after the last dose of AP505
6 secondary outcomes
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Time frame: From C1D1 until 7 days after treatment discontinuation/ termination.
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Time frame: From first dose until 7 days after treatment discontinuation/ termination.
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Time frame: From first dose until 7 days after treatment discontinuation/ termination.
To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors
Time frame: From first dose until 7 days after treatment discontinuation/ termination
To characterize the immunogenicity profile of AP505 in patients with advanced solid tumors
Time frame: From C1D1 (Cycle 1 is 15 days ; Cycle 2 onwards: each cycle is 28 days), until safety follow up (up to 90 days after the last dose).
To characterize the immunogenicity profile of AP505 in patients with advanced solid tumors
Time frame: From C1D1 (Cycle 1 is 15 days ; Cycle 2 onwards: each cycle is 28 days), until safety follow up (up to 90 days after the last dose).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AP505 in people with Advanced Solid Tumors, 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?
The sponsor lists 17 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Escalation : DLT Assessment (time frame: From Day1 to Day15 after first dose of AP505). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.