Actively Recruiting
A Phase 1, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients With Solid Tumors.
Led by AP Biosciences Inc. · Updated on 2025-12-29
36
Participants Needed
3
Research Sites
4 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
Researchers are investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of AP601, a fully human bispecific antibody, in patients with locally unresectable advanced or metastatic solid tumors who have not responded to standard treatments or have refused them. This Phase 1, open-label study aims to find the highest safe dose of AP601 for these patients by testing increasing doses across multiple groups. Participants will receive AP601 intravenously as a single infusion every two weeks for up to 12 months. The study has two parts: a dose escalation phase where up to six different dose levels (ranging from 0.5 mg/kg to 10 mg/kg) are evaluated using a 3+3 design to monitor for dose-limiting toxicities, and a possible dose expansion phase after completion of dose escalation. Infusion times are approximately 60 to 120 minutes. Throughout the study, participants will undergo regular assessments including safety monitoring for adverse events, laboratory tests, vital sign measurements, electrocardiograms, and tumor evaluations using RECIST criteria. Pharmacokinetics and immunogenicity of AP601 will be measured at multiple time points during treatment. The primary outcome focuses on determining the maximum tolerated dose and recommended phase 2 dose, with ongoing safety follow-up up to 90 days after the last dose and extended evaluations of antitumor activity and clinical benefit up to two years.
CONDITIONS
Brief 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 are relapsed or refractory to at least one standard therapy or have refused standard therapy.
- Eastern Cooperative Oncology Group performance status of 0 to 1 with an estimated life expectancy of at least 3 months.
- At least one measurable lesion (long diameter ≥1 cm) according to RECIST 1.1.
- Adequate organ and bone marrow function without growth factors, meeting specified lab criteria.
- Female participants must be nonchildbearing (surgically sterilized or postmenopausal) or agree to contraception and negative pregnancy tests if of childbearing potential.
- Male participants must agree to use contraception and not donate sperm during and after the study.
- Ability and willingness to comply with study assessments and protocol requirements.
You will not qualify if you...
- Receipt of any antitumor treatment or investigational products within 28 days before first dose.
- Prior treatment with CD73-targeted or CD137-targeted therapies.
- Major surgery within 28 days before first dose, except diagnostic biopsy.
- Unresolved toxicity from prior therapy above grade 1 except alopecia or stable irreversible Grade 2 toxicity.
- History of other malignancies active or treated within past 2 years, with specific exceptions.
- Prior immunotherapy-related adverse events leading to treatment discontinuation.
- Active or uncontrolled brain metastases or leptomeningeal disease.
- History of organ transplantation including stem cell transplantation.
- Recent blood transfusions or growth factor support within 14 days.
- Current significant infections including recent antibacterial, antifungal, or antiviral therapy or active hepatitis B, C, or HIV.
- Active or history of autoimmune disease or immunodeficiency.
- Recent systemic corticosteroids or immunosuppressive treatments within 14 days.
- Severe allergy to monoclonal antibodies.
- Breastfeeding or planning to breastfeed during the study and 90 days post-study.
- Recent alcohol or drug abuse.
- Cardiac dysfunction or serious cardiac conditions.
- Uncontrolled illnesses such as hypertension, diabetes, or severe gastric diseases.
- Receipt of live vaccine within 28 days before or during the study.
- Any other condition deemed unsuitable by the investigator including inability to comply with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive a single infusion of AP601 once every 2 weeks for up to 12 months. The infusion lasts approximately 60 to 120 minutes each time.
Biweekly visits for infusions, up to 24 infusions
Duration - Up to 2 years
Participants are monitored for safety and antitumor activity after completing treatment for up to 2 years.
Multiple follow-up visits including safety follow-up at 30 and 90 days after treatment and survival follow-up
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
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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