A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors
ConditionSolid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAP Biosciences Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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 standard-of-care therapy.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AP601
Treatment groups
36 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
AP Biosciences Inc.
Lead sponsor
Avance Clinical Pty Ltd.
Collaborator
Source ClinicalTrials.gov