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New treatment option for Solid Tumours
Official title A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07165067
What this study is testing
What is AP601?
AP601 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors. Patients must be relapsed or...
- Must agree not to donate sperm from signing the ICF until at aleast 90 days after the last dose of the study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception.
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
You likely can't join if
- Has received concurrent antitumor treatment or IPs within 28 days of C1D1. The antitumor treatments include chemotherapy, radiotherapy...
- 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...
- History of any other malignancy, which has been active or treated within the past 2 years, with the exception of thyroid cancer, cervical...
- Prior history of an irAE with immunotherapy-related toxicities that resulted in discontinuation of prior immunotherapy.
See the full eligibility criteria
- Patients with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors. Patients must be relapsed or refractory to at least one standard-of-care therapy, and/or have refused...
- Must agree not to donate sperm from signing the ICF until at aleast 90 days after the last dose of the study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception.
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
- 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Waratah, New South Wales, Australia
- Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waratah, New South Wales, Australia; Brisbane, Queensland, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.