Solid TumoursPhase 1NCT07165067

A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors

A Phase 1 study testing AP601 in people with Solid Tumours, run by AP Biosciences Inc. at 3 sites in Australia.

Recruiting

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

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumours
What is being tested?: AP601
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 3 sitesAustralia
Study dates: 21 Jan 2026to 30 Jan 2028
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

None listed.

Who cannot join

Has received concurrent antitumor treatment or IPs within 28 days of C1D1. The antitumor treatments include chemotherapy, radiotherapy, immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy.
Has received prior CD73-targeted and/or CD137-targeted therapeutics.
Has had major surgery within 28 days prior to C1D1 (excluding prior diagnostic biopsy).
Any unresolved toxicity (except alopecia) from prior therapy of ≥CTCAE Grade 1, prior to the day of the first dose of IP. Participants with Grade 2 toxicity that is not CS (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
History of any other malignancy, which has been active or treated within the past 2 years, with the exception of thyroid cancer, cervical intraepithelial neoplasia, basal cell carcinoma and squamous cell carcinoma.
Prior history of an irAE with immunotherapy-related toxicities that resulted in discontinuation of prior immunotherapy.

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Current symptomatic leptomeningeal disease or uncontrolled, untreated brain metastasis.
Has received any organ transplantation including allogeneic stem cell transplantation.
Has received blood transfusions or growth factor support ≤ 14 days prior to screening.
Has any significant acute or chronic infections including:
Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of AP601.
Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
Current active, or history of, any autoimmune disease that may relapse 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 AP601.
Known severe hypersensitivity reactions to monoclonal antibodies.
Breastfeeding (or planning to breastfeed) at any time during the study, and for 90 days following study completion.
Participants with a current or recent (within the past 12 months) diagnosis of alcohol or non-prescribed drug abuse, as defined by local guidelines.
Evidence of cardiac dysfunction (defined as myocardial infarction within the last 6 months, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias, or known left ventricular ejection fraction [LVEF] <55%) or other CS cardiac pathology likely to impair the participants ability to participate in the study.
Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, uncontrolled endocrinopathy, severe active peptic ulcer disease or gastritis.
Has received a live (or live attenuated) vaccination within 28 days of the first dose of AP601 and during the study period.
Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Trial locations and contacts

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

Grace Lu contact

886-2-2653-2886 ext. 710

cwlu@apbioinc.com

Australia3 sites, 3 recruiting

Pindara Private Hospital
Brisbane, Queensland, 4217
Mandeep Khurana, KhuranaM@ramsayhealth.com.au
Dr Marco Matos
Not yet recruiting
Epworth HealthCare
Melbourne, Victoria, 3121
Ashleigh Poh, +61 (03) 9426 8880, Ashleigh.Poh@epworth.org.au
A/Prof Sumitra Ananda
Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Jordan Cohen Dr, +61240143562, Jordan.cohen@healthnsw.gov.au
Jordan Cohen, Dr
Not yet recruiting

Other trials in Australia

About this study

Official title: A Phase 1, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients With Solid Tumors.

A Phase 1, Open-Label Study of the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients with Solid Tumours.The study is designed to find the highest dose of AP601 that can be given safely. Participants will be assigned to one of six cohorts. Each cohort will receive a different dose of the study medication, AP601, based on the body weight. Each cohort will initially enrol 1-3 participants. If no serious side effects are seen in the first participant(s), the next cohort will receive the next dose level.

Read the detailed description

Participants will receive a single infusion of AP601 once every 2 weeks (14 days) (Q2W) for up to 12 months.

Part 1 (Dose Escalation):

Part 1 is a dose escalation part, using an accelerated 3+3 design. Up to 6 dose levels are planned to be evaluated in Part 1.

Cohort 1 - 0.5mg/kg (1-6 participants) Cohort 2 - 1.25 mg/Kg (1-6 participants) Cohort 3 - 2.5 mg/Kg (3-6 participants) Cohort 4- 5.0 mg/Kg (3-6 participants) Cohort 5- 7.5 mg/Kg (3-6 participants) Cohort 6- 10.0 mg/Kg. (3-6 participants) At the first dose level, a single participant will be enrolled and observed for dose-limiting toxicities (DLTs) and adverse events (AEs) for 28 days (2 treatment cycles). If the participant does not experience any DLTs, then a new participant may be dosed at the next higher dose level and observed for the DLT period (28 days). There will be a maximum of 2 single-patient cohorts.

If in any of the single-patient cohorts a patient experiences a DLT, an additional 2 patients will be enrolled at that dose level and evaluated using 3+3 design rules.

Cohorts 3 and above will all use a standard 3+3 design, even if toxicity was not seen in the single-patient Cohorts 1 and 2.

Part 2 (Dose Expansion):

A dose expansion part may be initiated following completion of the dose escalation cohorts.

Conditions: Solid Tumours
Being tested: AP601
Keywords: solid tumours, advanced or metastatic solid tumours, open label

What participants receive

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

AP601Drug
AP601 is a fully human bispecific antibody designed for the treatment of CD73-expressing solid tumours. Participants will receive a single infusion of AP601 once every 2 weeks (14 days) (Q2W) for up to 12 months. All doses of AP601 will be admistered intraveneously. The infusion time for all doses of AP601 in each patient will be approximately 60 to 120 minutes.

Study groups in NCT07165067
Study group	Role	What they receive
Cohort 1	Experimental	Cohort 1: 0.5 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days) Receives: Drug: AP601
Cohort 2	Experimental	Cohort 2: 1.25 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days) Receives: Drug: AP601
Cohort 3	Experimental	Cohort 3: 2.5 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days) Receives: Drug: AP601
Cohort 4	Experimental	Cohort 4: 5.0 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days) Receives: Drug: AP601
Cohort 5	Experimental	Cohort 5: 7.5 mg/kg Receives: Drug: AP601
Cohort 6	Experimental	Cohort 6: 10.0 mg/kg Receives: Drug: AP601

What is being measured

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

To determine the tolerability (MTD and/or maximum administered dose [MAD] of AP601 in patients with solid tumours.
Estimate of the MTD based on DLTs observed during the DLT evaluation period.
Measured: Initial 28 days from the first dose of AP601 which is Cycle1Day1 (each cycle is 14 days) until Cycle2Day14 (each cycle is 14 days)
To determine the tolerability of Recommend Phase 2 Dose [RP2D])- MTD and/or maximum administered dose [MAD] of AP601 in patients with solid tumours.
RP2D is based on the safety data - Estimate of the MTD based on DLTs observed during the DLT evaluation period
Measured: TEAEs and SAEs will be assessed at Screening until 90-day safety follow up visit.
To determine the tolerability of Recommend Phase 2 Dose [RP2D])
RP2D tolerability is based on Pharmacokinetics data- blood samples will be collected to assess this.
Measured: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose (each cycle is 14 days), 0-6 hours, End of Trial Visit.
To determine the tolerability of Recommend Phase 2 Dose [RP2D])
RP2D tolerability is based on Pharmacodynamics data- blood samples will be collected to assess this
Measured: PD will be assessed Cycle 1 - pre-dose, 24 hous, 72 hours, 168 hours. Cycle 2- pre-dose, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Pre-dose (each cycle is 14days) and at End of Trial Visit.
To determine the tolerability of Recommend Phase 2 Dose [RP2D]
Recommend Phase 2 Dose [RP2D] is based on antitumor activity data.
Measured: Antitumour activity data will collected at End of Trial Visit , Safety Follow Up Visit (End of Trial + 30 days), Safety FUP Visit (End of Trial + 90 days) and at Survival Follow Up.
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (haematology)
Haematology - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle 3 Day1 to Cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit (EOT) and Safety Follow Up (EOT+ 30 days)
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (clinical chemistry)
Clinical Chemistry- blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 until Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (Coagulation)
Coagulation- blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 to last Cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (Thyroid Function tests )
Thyroid Function tests - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 - until last Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis)
Urine samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 - until last Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (End of Trial Visit+ 30 days)
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in Vital signs measurements Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature and respiratory rate [RR]
Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine, respiratory rate is measured manually via 60-second count [RR]. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
Measured: Assessed at Screening, Cycles 1 and 2 - Day 1, Day 2, Day 4, Day 8 Cycle 3 Day 1 - until last cycle 24 Day 1 (each cycle is 14 days), End of Trial Visit (EOT), Safety FUP (EOT + 30 days).
To determine the tolerability of RP2D- Number of Participants with a Change from baseline in body weight
Weight will be measured utilising scales.
Measured: Assessed at Screening, Cycles 1 and 2 - Day 1, Day 2, Day 4, Day 8 Cycle 3 Day 1 - until last cycle 24 Day 1(each cycle is 14 days), End of Trial Visit(EOT), Safety FUP (EOT + 30 days).
To determine the tolerability of RP2D- Change from baseline in Eastern Cooperative Oncology Group (ECOG) score
Graded using a 6 point scale
Measured: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 up until last cycle 24 Day1 (each cycle is of 14 days), End of Trial Visit(EOT)and Safety FUP (EOT + 30 days) Visit.
To determine the tolerability of RP2D- Change from baseline in measurements of HR in beats per minute
12-lead ECG parameters include the measurements of HR in beats per minute. All ECGs will be performed in triplicate.
Measured: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit(EOT) and Safety FUP (EOT + 30 days).
To determine the tolerability of RP2D- Change from baseline in measurements of PR interval via 12-lead electrocardiogram
12-lead ECG parameters include the measurements of PR interval. All ECGs will be performed in triplicate.
Measured: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT ) Visit and Safety FUP (EOT + 30 days).
To determine the tolerability of RP2D- Change from baseline in measurements of QT interval via 12-lead electrocardiogram
12-lead ECG parameters include measurements of QT duration. All ECGs will be in triplicate.
Measured: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT) Visit and Safety FUP (EOT + 30 days).
To determine the tolerability of RP2D- Change from baseline in measurements of QRS duration via 12-lead electrocardiogram
12-lead ECG parameters include the measurements of QRS duration. All 12-lead ECGs will be in triplicate.
Measured: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT) Visit and Safety FUP (EOT + 30 days).

Secondary outcomes (14)

To assess the PK of AP601 in patients with solid tumours - Serum PK concentration of AP601.
Blood samples will be collected to assess PK.
Measured: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24 - Predose (each cycle is 14 days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Individual maximum concentration values, directly determined from the serum concentration time profiles for each participant (Cmax)
Blood samples are collected to assess PK.
Measured: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cyle 24- Predose(each cycle is 14 days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours -Serum clearance following IV administration (CL)
Blood samples are collected to assess PK.
Measured: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 -to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours -Area under the serum concentration-time curve (AUC) from time zero to 168 hours post-dose (AUC0-168)
Blood samples are collected to assess PK.
Measured: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24 Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - AUC from time zero to the last time point with measurable concentration using the linear trapezoidal rule (AUClast)
Blood samples are collected to assess PK.
Measured: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - The time to attain maximum concentration (Tmax)
Blood samples are collected to assess PK.
Measured: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose (each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Terminal elimination half-life (T1/2)
Blood samples are collected to assess PK.
Measured: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Volume of distribution (Vz)
Blood samples are collected to assess PK.
Measured: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Trough concentration (Ctrough)
Blood samples are collected to assess PK.
Measured: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hrs, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the Immunogenicity of AP601 in patients with solid tumours.
Immunogenicity parameters will be assessed through analysis of the number and percentage of patients who develop anti-drug antibodies (ADA).
Measured: Assessed at Cycle1 Day1 - Pre-dose, Cycle2 Day1 - Predose, Cycle3 Day1- Predose until Last Cycle 24 Day 1 (each cycle is of 14 days) and End of Trial Visit.
To assess the antitumor activity of AP601 in patients with solid tumours.
This data will be collected through a follow up phone call following the last dose of AP601, through to last contact with the participant.
Measured: Antitumour activity data will collected at End of Trial(EOT) Visit , Safety FUP Visit (EOT + 30 days), Safety Follow Up Visit (EOT + 90 days) and at Survival Follow Up.
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Objective Response Rate (ORR)
Preliminary efficacy will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: Upto 2 years
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Disease Control Rate (DCR)
Preliminary efficacy will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: Upto 2 years
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Clinical Benefit Response (CBR)
Preliminary efficacy will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: Upto 2 years

Timeline

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

21 Jan 202630 Jan 2028

First posted10 Sep 2025
Study start21 Jan 2026 (estimated)
Primary completion27 Dec 2027 (estimated)
Study completion30 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumoursStudies 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
Model description: AP601 is a fully human bispecific antibody designed for the treatment of CD73-expressing solid tumours. AP601 represents an innovative therapeutic approach, targeting both CD73 and CD137 to synergistically enhance antitumour immunity through two synergistic mechanisms. CD73, an ecto-enzyme frequently overexpressed in various cancers, plays a pivotal role in immune suppression by converting adenosine monophosphate into adenosine, which suppresses T cell activity within the tumour microenvironment (TME). By inhibiting CD73, AP601 mitigates adenosine-mediated immunosuppression, fostering a more effective immune response. Simultaneously, AP601 targets CD137, a key costimulatory receptor on activated T cells and natural killer cells. Engagement of CD137 stimulates proliferation and enhances the cytotoxic function of these immune cells. AP601's dual-targeting design restricts CD137 activation to the TME. This targeted approach minimizes systemic toxicity and enhances therapeutic specificity.
Masking: None (open label)
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07165067
Sponsor's protocol ID: AP601-101
Status last verified: Dec 2025
First submitted: 20 Aug 2025
Last updated: 29 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.

Interested in taking part?

Grace Lu

886-2-2653-2886 ext. 710

cwlu@apbioinc.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients With Solid Tumors.
ClinicalTrials.gov ID: NCT07165067
Acronym / sponsor ID: AP601-101
Conditions: Solid Tumours
Keywords: solid tumours, advanced or metastatic solid tumours, open label
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 36 participants (estimated)
Lead sponsor: AP Biosciences Inc.Industry (pharma, biotech, devices)
Collaborators: Avance Clinical Pty Ltd.
Study start: 21 Jan 2026 (estimated)
Primary completion: 27 Dec 2027 (estimated)
Study completion: 30 Jan 2028 (estimated)
First posted: 10 Sep 2025 (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.

Detailed description

Participants will receive a single infusion of AP601 once every 2 weeks (14 days) (Q2W) for up to 12 months.

Part 1 (Dose Escalation):

Part 1 is a dose escalation part, using an accelerated 3+3 design. Up to 6 dose levels are planned to be evaluated in Part 1.

If in any of the single-patient cohorts a patient experiences a DLT, an additional 2 patients will be enrolled at that dose level and evaluated using 3+3 design rules.

Cohorts 3 and above will all use a standard 3+3 design, even if toxicity was not seen in the single-patient Cohorts 1 and 2.

Part 2 (Dose Expansion):

A dose expansion part may be initiated following completion of the dose escalation cohorts.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: AP601 is a fully human bispecific antibody designed for the treatment of CD73-expressing solid tumours. AP601 represents an innovative therapeutic approach, targeting both CD73 and CD137 to synergistically enhance antitumour immunity through two synergistic mechanisms. CD73, an ecto-enzyme frequently overexpressed in various cancers, plays a pivotal role in immune suppression by converting adenosine monophosphate into adenosine, which suppresses T cell activity within the tumour microenvironment (TME). By inhibiting CD73, AP601 mitigates adenosine-mediated immunosuppression, fostering a more effective immune response. Simultaneously, AP601 targets CD137, a key costimulatory receptor on activated T cells and natural killer cells. Engagement of CD137 stimulates proliferation and enhances the cytotoxic function of these immune cells. AP601's dual-targeting design restricts CD137 activation to the TME. This targeted approach minimizes systemic toxicity and enhances therapeutic specificity.

Arm	Type	Receives
Cohort 1	Experimental	Drug: AP601Cohort 1: 0.5 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)
Cohort 2	Experimental	Drug: AP601Cohort 2: 1.25 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)
Cohort 3	Experimental	Drug: AP601Cohort 3: 2.5 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)
Cohort 4	Experimental	Drug: AP601Cohort 4: 5.0 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)
Cohort 5	Experimental	Drug: AP601Cohort 5: 7.5 mg/kg
Cohort 6	Experimental	Drug: AP601Cohort 6: 10.0 mg/kg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (21 listed)

Has received concurrent antitumor treatment or IPs within 28 days of C1D1. The antitumor treatments include chemotherapy, radiotherapy, immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy.
Has received prior CD73-targeted and/or CD137-targeted therapeutics.
Has had major surgery within 28 days prior to C1D1 (excluding prior diagnostic biopsy).
Any unresolved toxicity (except alopecia) from prior therapy of ≥CTCAE Grade 1, prior to the day of the first dose of IP. Participants with Grade 2 toxicity that is not CS (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
History of any other malignancy, which has been active or treated within the past 2 years, with the exception of thyroid cancer, cervical intraepithelial neoplasia, basal cell carcinoma and squamous cell carcinoma.

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
AP601AP601 is a fully human bispecific antibody designed for the treatment of CD73-expressing solid tumours. Participants will receive a single infusion of AP601 once every 2 weeks (14 days) (Q2W) for up to 12 months. All doses of AP601 will be admistered intraveneously. The infusion time for all doses of AP601 in each patient will be approximately 60 to 120 minutes.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6

Primary outcome

To determine the tolerability (MTD and/or maximum administered dose [MAD] of AP601 in patients with solid tumours.
Time frame: Initial 28 days from the first dose of AP601 which is Cycle1Day1 (each cycle is 14 days) until Cycle2Day14 (each cycle is 14 days)
Estimate of the MTD based on DLTs observed during the DLT evaluation period.
To determine the tolerability of Recommend Phase 2 Dose [RP2D])- MTD and/or maximum administered dose [MAD] of AP601 in patients with solid tumours.
Time frame: TEAEs and SAEs will be assessed at Screening until 90-day safety follow up visit.
RP2D is based on the safety data - Estimate of the MTD based on DLTs observed during the DLT evaluation period
To determine the tolerability of Recommend Phase 2 Dose [RP2D])
Time frame: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose (each cycle is 14 days), 0-6 hours, End of Trial Visit.
RP2D tolerability is based on Pharmacokinetics data- blood samples will be collected to assess this.
To determine the tolerability of Recommend Phase 2 Dose [RP2D])
Time frame: PD will be assessed Cycle 1 - pre-dose, 24 hous, 72 hours, 168 hours. Cycle 2- pre-dose, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Pre-dose (each cycle is 14days) and at End of Trial Visit.
RP2D tolerability is based on Pharmacodynamics data- blood samples will be collected to assess this
To determine the tolerability of Recommend Phase 2 Dose [RP2D]
Time frame: Antitumour activity data will collected at End of Trial Visit , Safety Follow Up Visit (End of Trial + 30 days), Safety FUP Visit (End of Trial + 90 days) and at Survival Follow Up.
Recommend Phase 2 Dose [RP2D] is based on antitumor activity data.
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (haematology)
Time frame: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle 3 Day1 to Cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit (EOT) and Safety Follow Up (EOT+ 30 days)
Haematology - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (clinical chemistry)
Time frame: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 until Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
Clinical Chemistry- blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (Coagulation)
Time frame: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 to last Cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
Coagulation- blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (Thyroid Function tests )
Time frame: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 - until last Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
Thyroid Function tests - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis)
Time frame: Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 - until last Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (End of Trial Visit+ 30 days)
Urine samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in Vital signs measurements Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature and respiratory rate [RR]
Time frame: Assessed at Screening, Cycles 1 and 2 - Day 1, Day 2, Day 4, Day 8 Cycle 3 Day 1 - until last cycle 24 Day 1 (each cycle is 14 days), End of Trial Visit (EOT), Safety FUP (EOT + 30 days).
Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine, respiratory rate is measured manually via 60-second count [RR]. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
To determine the tolerability of RP2D- Number of Participants with a Change from baseline in body weight
Time frame: Assessed at Screening, Cycles 1 and 2 - Day 1, Day 2, Day 4, Day 8 Cycle 3 Day 1 - until last cycle 24 Day 1(each cycle is 14 days), End of Trial Visit(EOT), Safety FUP (EOT + 30 days).
Weight will be measured utilising scales.
To determine the tolerability of RP2D- Change from baseline in Eastern Cooperative Oncology Group (ECOG) score
Time frame: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 up until last cycle 24 Day1 (each cycle is of 14 days), End of Trial Visit(EOT)and Safety FUP (EOT + 30 days) Visit.
Graded using a 6 point scale
To determine the tolerability of RP2D- Change from baseline in measurements of HR in beats per minute
Time frame: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit(EOT) and Safety FUP (EOT + 30 days).
12-lead ECG parameters include the measurements of HR in beats per minute. All ECGs will be performed in triplicate.
To determine the tolerability of RP2D- Change from baseline in measurements of PR interval via 12-lead electrocardiogram
Time frame: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT ) Visit and Safety FUP (EOT + 30 days).
12-lead ECG parameters include the measurements of PR interval. All ECGs will be performed in triplicate.
To determine the tolerability of RP2D- Change from baseline in measurements of QT interval via 12-lead electrocardiogram
Time frame: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT) Visit and Safety FUP (EOT + 30 days).
12-lead ECG parameters include measurements of QT duration. All ECGs will be in triplicate.
To determine the tolerability of RP2D- Change from baseline in measurements of QRS duration via 12-lead electrocardiogram
Time frame: Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT) Visit and Safety FUP (EOT + 30 days).
12-lead ECG parameters include the measurements of QRS duration. All 12-lead ECGs will be in triplicate.

14 secondary outcomes

To assess the PK of AP601 in patients with solid tumours - Serum PK concentration of AP601.
Time frame: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24 - Predose (each cycle is 14 days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Individual maximum concentration values, directly determined from the serum concentration time profiles for each participant (Cmax)
Time frame: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cyle 24- Predose(each cycle is 14 days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours -Serum clearance following IV administration (CL)
Time frame: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 -to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours -Area under the serum concentration-time curve (AUC) from time zero to 168 hours post-dose (AUC0-168)
Time frame: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24 Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - AUC from time zero to the last time point with measurable concentration using the linear trapezoidal rule (AUClast)
Time frame: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - The time to attain maximum concentration (Tmax)
Time frame: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose (each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Terminal elimination half-life (T1/2)
Time frame: Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Volume of distribution (Vz)
Time frame: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the PK of AP601 in patients with solid tumours - Trough concentration (Ctrough)
Time frame: Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hrs, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
To assess the Immunogenicity of AP601 in patients with solid tumours.
Time frame: Assessed at Cycle1 Day1 - Pre-dose, Cycle2 Day1 - Predose, Cycle3 Day1- Predose until Last Cycle 24 Day 1 (each cycle is of 14 days) and End of Trial Visit.
To assess the antitumor activity of AP601 in patients with solid tumours.
Time frame: Antitumour activity data will collected at End of Trial(EOT) Visit , Safety FUP Visit (EOT + 30 days), Safety Follow Up Visit (EOT + 90 days) and at Survival Follow Up.
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Objective Response Rate (ORR)
Time frame: Upto 2 years
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Disease Control Rate (DCR)
Time frame: Upto 2 years
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Clinical Benefit Response (CBR)
Time frame: Upto 2 years

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 29 Dec 2025.
Individual participant dataSharing planned: No. Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.

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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.

Grace Lu contact

886-2-2653-2886 ext. 710

cwlu@apbioinc.com

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AP601 in people with Solid Tumours, 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 0 inclusion and 21 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 29 Dec 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 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?

Contact Grace Lu (886-2-2653-2886 ext. 710, cwlu@apbioinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the tolerability (MTD and/or maximum administered dose [MAD] of AP601 in patients with solid tumours. (time frame: Initial 28 days from the first dose of AP601 which is Cycle1Day1 (each cycle is 14 days) until Cycle2Day14 (each cycle is 14 days)). The study lists 17 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 NCT07165067.

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 29 Dec 2025.