Actively Recruiting
A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors
Led by AP Biosciences Inc. · Updated on 2025-12-29
36
Participants Needed
3
Research Sites
105 weeks
Total Duration
On this page
Sponsors
A
AP Biosciences Inc.
Lead Sponsor
A
Avance Clinical Pty Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed locally unresectable advanced or metastatic solid tumors who have relapsed or are refractory to at least one standard therapy or have refused standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.
- Estimated life expectancy of at least 3 months.
- At least one measurable lesion of 1 cm or larger by RECIST Version 1.1 criteria.
- Adequate organ and bone marrow function without growth factors, meeting specific laboratory values for neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, coagulation, creatinine, and albumin.
- Female volunteers must be non-childbearing or surgically sterilized at least 6 weeks before screening, or postmenopausal.
- Females of childbearing potential must have a negative pregnancy test, agree not to become pregnant or donate ova, and use contraception from one month before screening until 90 days after last dose if not exclusively in a same-sex relationship or abstinent.
- Male volunteers must agree not to donate sperm from signing consent until at least 90 days after last dose and use contraception if having sexual intercourse with a woman who could become pregnant.
- Willing and able to comply with all study assessments and protocol requirements.
You will not qualify if you...
- Received any antitumor treatment or investigational products within 28 days before first dose, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy.
- Prior treatment with CD73-targeted or CD137-targeted therapies.
- Major surgery within 28 days before first dose, excluding diagnostic biopsy.
- Unresolved toxicity from prior therapy greater than CTCAE Grade 1 except alopecia.
- History of other malignancies active or treated within past 2 years, except certain skin and cervical cancers.
- Prior immunotherapy-related adverse events causing discontinuation.
- Current symptomatic leptomeningeal disease or uncontrolled brain metastases.
- History of organ transplantation including allogeneic stem cell transplant.
- Blood transfusions or growth factor support within 14 days before screening.
- Significant acute or chronic infections requiring systemic therapy within 14 days before first dose or known active hepatitis B, C, or HIV.
- Current or history of autoimmune disease or immunodeficiency.
- Systemic corticosteroid or immunosuppressive therapy within 14 days before first dose.
- Known severe hypersensitivity to monoclonal antibodies.
- Breastfeeding or planning to breastfeed during study and for 90 days after.
- Current or recent alcohol or drug abuse within past 12 months.
- Evidence of cardiac dysfunction or other serious cardiac conditions.
- Uncontrolled illnesses such as hypertension, diabetes, endocrinopathies, or severe gastrointestinal disease.
- Live or live attenuated vaccination within 28 days before first dose or during study.
- Any other condition or prior therapy making the participant unsuitable in the opinion of the investigator, including likely noncompliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Not Yet Recruiting
2
Pindara Private Hospital
Brisbane, Queensland, Australia, 4217
Not Yet Recruiting
3
Epworth HealthCare
Melbourne, Victoria, Australia, 3121
Actively Recruiting
Research Team
G
Grace Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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