Advanced Solid TumorPhase 1/2NCT06669975
A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors
A Phase 1/2 study testing AP402 (Part 1 Dose esclation) and AP402 (Part 2 Dose Expansion) in people with Advanced Solid Tumor, run by AP Biosciences Inc. at 3 sites in Australia.
Trial summary
This is a Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- AP402 (Part 1 Dose esclation) and AP402 (Part 2 Dose Expansion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 3 sitesAustralia
- Study dates
- 22 Apr 2025to 1 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
Who may be able to join
- Patients with histologically or cytologically proven locally unresectable advanced or metastatic HER2-postive solid tumors which no standard therapy suitable.
- Adult patients aged ≥ 18 years at the time of signing informed consent form (ICF).
- Written informed consent by the patients or the patient's legally authorized representative prior to Screening.
- Patients 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 (long diameter ≥ 1cm) lesion by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor lesions situated in a previously irradiated area are not considered assessable 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.
- Patients with adequate organ function defined by the following:
Show all 18Show fewer
- Absolute neutrophil count ≥ 1.5 × 109 /L.
- Platelet count ≥ 100 × 109 /L.
- Hemoglobin ≥ 9 g/dL.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or < 5 × ULN if hepatic metastases present.
- Serum total bilirubin ≤ 1.5 × ULN (or < 3 × ULN for patients 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 patients on a stable dose of anticoagulants.
- Estimated creatinine clearance > 45 mL/min according to the Cockcroft Gault formula.
- Albumin ≥ 28 g/L NOTE: Patients must not have required blood transfusions or growth factor support ≤ 14 days before sample collection at Screening.
- Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 90 days after study completion, including the Follow-up period. Effective forms of contraception are defined in Section 7.3.2. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for ≥12 months (postmenopausal status is to be confirmed through testing of FSH levels ≥ 40 IU/L at Screening for amenorrhoeic female patients).
- Males must be surgically sterile (>30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method (see Section 7.3.2) must be used from Screening until study completion, including the Follow-up period. Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.
Who cannot join
- Patients who have received concurrent antitumor treatment or investigational products within 28 days or 5 half-lives before the start of IP, whichever comes earlier. The antitumor treatments include chemotherapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin.
- Patients who had received CD137-targeted therapeutics within 28 days or 5 half-lives before the start of IP, whichever comes earlier.
- Patients who had major surgery within 28 days before the start of IP (excluding prior diagnostic biopsy).
- Patients 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, and< Grade 2 sensory neuropathy.
- Patients with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
- Patients 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.
Show all 29Show fewer
- Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Patients 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:
- Brain imaging at Screening shows no evidence of interim progression, patient is clinically stable for at least 2 weeks and without evidence of new brain metastases.
- Measurable disease outside the CNS.
- No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 2 weeks before the first dose of AP402; anticonvulsants at a stable dose are allowed.
- Patients who received any organ transplantation including allogeneic stem cell transplantation.
- Patients with significant acute or chronic infections including, among others:
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of AP402.
- 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 patients with unknown HIV status and patients 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. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at Screening should have been treated for > 2 weeks before the first dose of AP402.
- Patients with active hepatitis C.
- NOTE: Patients 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 patients testing positive for HCV antibody. Patients receiving antivirals at Screening should have been treated for > 2 weeks before the first dose of AP402.
- Patients with active or history of any autoimmune disease that may relapse (patients with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of AP402.
- Patients with known severe hypersensitivity reactions to monoclonal antibodies.
- Patients with pregnancy or lactation period. Note: a negative pregnancy test is required for WOCBP.
- Patients with known alcohol or drug abuse.
- Patients with clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to the first dose of AP402), myocardial infarction (< 6 months prior to the first dose of AP402), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication, or baseline QTcF interval > 480 msec.
- Patients with a left ventricular ejection fraction (LVEF) lower than 55% at Screening.
- Patients with any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Patients with live (or live attenuated) vaccination within 28 days of the first dose of AP402 and during the study period.
- NOTE: COVID-19 vaccinations are permitted while a patient is on the study.
- Patients with all other significant diseases, in the opinion of the Investigator, might impair the patient's tolerance of the IP.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Not yet recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5043
study coordinator
- Not yet recruiting
Macquarie University Clinical Trials Unit
Macquarie, New South Wales, 2109
Study coordinator
- Recruiting
Linear Clinical Research
Perth, Western Australia, 6009
About this study
Official title: A Phase 1/2, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors
This is a Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.
Read the detailed description
The study will consist of 2 parts:
- Part 1 (Dose Escalation): Dose escalation will consist of 7 cohorts where an IV infusion of AP402 will be administered once every 2 weeks to determine the maximum tolerated dose (MTD) (ie, the highest safe dose administered to patients) and the recommended phase 2 dose (RP2D) of AP402. For dose-escalation, an accelerated dose titration design will be utilized for the first 2 dose cohorts, followed by a standard 3+3 dose titration design for the remaining 5 cohorts. Up to 42 patients will be enrolled in Part 1.
- Part 2 (Dose Expansion): After the MTD and/or RP2D are determined by the Safety Review Committee (SRC) (see Section 6.5), additional patients will be enrolled in Part 2 and will be treated with AP402 at that dose once every 2 weeks. Part 2 will be based on the Simon's two-stage optimal design (Simon, 1989) and is expected to enroll approximately 43 patients in 1 or 2 selected tumor types.
Administration of the IP will continue for 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, intolerable toxicity, withdrawal of consent, study completion, death or other reasons leading to treatment discontinuation, whichever comes first
- Conditions
- Advanced Solid Tumor
- Being tested
- AP402 (Part 1 Dose esclation), AP402 (Part 2 Dose Expansion)
- Keywords
- HER2-positive, local solid tumors, advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP402 (Part 1 Dose esclation)Drug
Dose escalation will consist of 7 cohorts where an Intraveous infusion of AP402 will be administered once every 2 weeks to determine the maximum tolerated dose (MTD) (ie, the highest safe dose administered to patients) and the recommended phase 2 dose (RP2D) of AP402.
AP402 (Part 2 Dose Expansion)Drug
After the MTD and/or RP2D are determined by the SRC, additional patients will be enrolled in Phase 2 dose expansion and will be treated with AP402 at that dose.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose escalation) | Experimental | Not described Receives: Drug: AP402 (Part 1 Dose esclation) |
| Part 2 (Dose Expansion) | Experimental | Not described Receives: Drug: AP402 (Part 2 Dose Expansion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of Maximum tolerated dose (MTD)
This will be based on dose limiting toxicities (DLT) observed during the DLT evaluation period.
Measured: Baseline to 90 days after the last dose
Number of participants with Adverse events (AEs) and Serious Adverse events (SAE) as assessed by CTCAE V5
Measured: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- Cmax (Maximum plasma concentration)
Measured: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- Tmax (time for maximum concentration)
Measured: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- AUC (Area under curve)
Measured: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- T1/2 (terminal half-life)
Measured: Baseline to 90 days after the last dose
Secondary outcomes (11)
To evaluate objective response rate (ORR)
The proportion of patients whose best overall response (BOR) is either confirmed complete responses (CR) or confirmed partial responses (PR).
Measured: Baseline to 30 days after the last dose
Number of patients with disease Control Rate (DCR)
The proportion of patients whose best overall response of confirmed CR, confirmed PR, or (confirmed) stable disease (SD) that was assessed at least 4 weeks (28 days) following the initiation of AP402
Measured: Baseline to 90 days after the last dose
Number of patients with changes in duration of objective response (DOOR)
The time from first documented objective response (confirmed CR or confirmed PR) until the earlier of disease progression or death from any cause, whichever occurs first.
Measured: Baseline to 30 days after the last dose
Duration of disease control response (DODC):
The time from first documented disease control response (confirmed CR, confirmed PR, or confirmed SD) until the earlier of disease progression or death from any cause, whichever occurs first. This will only be applicable for patients who have a confirmed best overall response of CR, PR, or SD. Patients without the events (progressive disease or death) will be censored at the date of their last tumor assessment.
Measured: Baseline to 30 days after the last dose
To assess progression-free survival (PFS):
The time from start of study treatment to the earlier of either disease progression or death from any cause, whichever occurs first.
Measured: Up to 48 months
To assess overall Survival (OS)
The time from start of study treatment to the date of death from any cause. Patients alive will be censored at the date of last known alive.
Measured: Up to 48 months
To assess time to Objective Response (TTOR):
The time from start of study treatment to the first documented objective response (confirmed CR or confirmed PR), whichever occurs first.
Measured: Baseline to 30 days after the last dose
To assess time to disease control response (TTDC):
The time from start of study treatment to the first documented disease control response (confirmed CR, confirmed PR, or confirmed SD (at least 4 weeks (28 days) following the initiation of AP402)), whichever occurs first.
Measured: Baseline to 30 days after the last dose
Serum concentration of AP402
Measured: Baseline to 30 days after the last dose
To evaluate immunogenicity by the number and percentage of patients who develop ADA
Measured: Baseline to 30 days after the last dose
To evaluate immunogenicity by the number and percentage of patients who develop neutralizing antibodies (if applicable).
Measured: Baseline to 30 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 posted1 Nov 2024
- Study start22 Apr 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AP Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669975
- Sponsor's protocol ID
- AP402-101
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06669975
- Acronym / sponsor ID
- AP402-101
- Conditions
- Advanced Solid Tumor
- Keywords
- HER2-positive, local solid tumors, advanced solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- AP Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 Nov 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 Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.
Detailed description
The study will consist of 2 parts:
- Part 1 (Dose Escalation): Dose escalation will consist of 7 cohorts where an IV infusion of AP402 will be administered once every 2 weeks to determine the maximum tolerated dose (MTD) (ie, the highest safe dose administered to patients) and the recommended phase 2 dose (RP2D) of AP402. For dose-escalation, an accelerated dose titration design will be utilized for the first 2 dose cohorts, followed by a standard 3+3 dose titration design for the remaining 5 cohorts. Up to 42 patients will be enrolled in Part 1.
- Part 2 (Dose Expansion): After the MTD and/or RP2D are determined by the Safety Review Committee (SRC) (see Section 6.5), additional patients will be enrolled in Part 2 and will be treated with AP402 at that dose once every 2 weeks. Part 2 will be based on the Simon's two-stage optimal design (Simon, 1989) and is expected to enroll approximately 43 patients in 1 or 2 selected tumor types.
Administration of the IP will continue for 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, intolerable toxicity, withdrawal of consent, study completion, death or other reasons leading to treatment discontinuation, whichever comes first
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose escalation) | Experimental | Drug: AP402 (Part 1 Dose esclation) |
| Part 2 (Dose Expansion) | Experimental | Drug: AP402 (Part 2 Dose Expansion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with histologically or cytologically proven locally unresectable advanced or metastatic HER2-postive solid tumors which no standard therapy suitable.
- Adult patients aged ≥ 18 years at the time of signing informed consent form (ICF).
- Written informed consent by the patients or the patient's legally authorized representative prior to Screening.
- Patients 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 (long diameter ≥ 1cm) lesion by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor lesions situated in a previously irradiated area are not considered assessable 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.
Key exclusion criteria (29 listed)
- Patients who have received concurrent antitumor treatment or investigational products within 28 days or 5 half-lives before the start of IP, whichever comes earlier. The antitumor treatments include chemotherapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin.
- Patients who had received CD137-targeted therapeutics within 28 days or 5 half-lives before the start of IP, whichever comes earlier.
- Patients who had major surgery within 28 days before the start of IP (excluding prior diagnostic biopsy).
- Patients 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, and< Grade 2 sensory neuropathy.
- Patients with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
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 |
|---|---|---|
| AP402 (Part 1 Dose esclation)Dose escalation will consist of 7 cohorts where an Intraveous infusion of AP402 will be administered once every 2 weeks to determine the maximum tolerated dose (MTD) (ie, the highest safe dose administered to patients) and the recommended phase 2 dose (RP2D) of AP402. | Drug | Part 1 (Dose escalation) |
| AP402 (Part 2 Dose Expansion)After the MTD and/or RP2D are determined by the SRC, additional patients will be enrolled in Phase 2 dose expansion and will be treated with AP402 at that dose. | Drug | Part 2 (Dose Expansion) |
Primary outcome
Estimate of Maximum tolerated dose (MTD)
Time frame: Baseline to 90 days after the last dose
This will be based on dose limiting toxicities (DLT) observed during the DLT evaluation period.
Number of participants with Adverse events (AEs) and Serious Adverse events (SAE) as assessed by CTCAE V5
Time frame: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- Cmax (Maximum plasma concentration)
Time frame: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- Tmax (time for maximum concentration)
Time frame: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- AUC (Area under curve)
Time frame: Baseline to 90 days after the last dose
To evaluate R2PD based on PK parameters- T1/2 (terminal half-life)
Time frame: Baseline to 90 days after the last dose
11 secondary outcomes
To evaluate objective response rate (ORR)
Time frame: Baseline to 30 days after the last dose
Number of patients with disease Control Rate (DCR)
Time frame: Baseline to 90 days after the last dose
Number of patients with changes in duration of objective response (DOOR)
Time frame: Baseline to 30 days after the last dose
Duration of disease control response (DODC):
Time frame: Baseline to 30 days after the last dose
To assess progression-free survival (PFS):
Time frame: Up to 48 months
To assess overall Survival (OS)
Time frame: Up to 48 months
To assess time to Objective Response (TTOR):
Time frame: Baseline to 30 days after the last dose
To assess time to disease control response (TTDC):
Time frame: Baseline to 30 days after the last dose
Serum concentration of AP402
Time frame: Baseline to 30 days after the last dose
To evaluate immunogenicity by the number and percentage of patients who develop ADA
Time frame: Baseline to 30 days after the last dose
To evaluate immunogenicity by the number and percentage of patients who develop neutralizing antibodies (if applicable).
Time frame: Baseline to 30 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 25 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AP402 (Part 1 Dose esclation) and AP402 (Part 2 Dose Expansion) in people with Advanced Solid Tumor, run by AP Biosciences Inc. at 3 sites in Australia.
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 18 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 Linnea Shen (+886-2-2653-2886, yashen@apbioinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate of Maximum tolerated dose (MTD) (time frame: Baseline to 90 days after the last dose). The study lists 6 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 25 Apr 2025.