CW-301 FIH Study of CAN016
ConditionPatients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanwell Biotech Limited
About this trial
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors
Eligibility criteria
Qualifiers
Provide informed consent voluntarily
Male or female patients ≥18 years of age.
Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.
For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADC and should be refractory to or intolerant of exiting therapy(ies) known to provide clinical benefit for their condition;
Disqualifiers
Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.
Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
Patients have autologous transplantation within 3 months.
Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.
Trial design
Treatments tested in this trial
- CAN016
- CAN016
Treatment groups
90 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov