Intratumoral CAN2109 in Subjects With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanwell Biotech Limited
About this trial
A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to provide written informed consent and willing to comply with the study's requirements.
Male or female age ≥ 18 years at screening.
Performance status of 0-1 on the ECOG Performance Scale.
Disqualifiers
Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
Has an active infection requiring systemic therapy.
New York Heart Association Class 3 or 4 congestive heart failure
Trial design
Design model
Single group
Treatments tested in this trial
CAN2109
DrugCAN2109 IT injection (once every 3 weeks)
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: CAN2109Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety
determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers.
Time frame
12 months2
Recommended Phase 2 Dose (RP2D)
To determine a recommended phase 2 dose of CAN21909 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time frame
12 months3
tolerability
determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers.
Time frame
12 monthsSecondary outcomes
1
To determine the efficacy of CAN2109
Proportion of patients experiencing a tumor response or a stable disease according to RECIST 1.1 or iRECIST 1.1 as appropriate.
Time frame
12 months2
To evaluate the pharmacodynamics of CAN2109
Maximum observed plasma and tumor concentration of CAN2109 after IT administration.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov