Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors
NCT ID: NCT04987112
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2022-01-20
2024-12-30
Brief Summary
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Detailed Description
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Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAN1012 single agent
CAN1012 intratumoral injection given alone
CAN1012
CAN1012 IT injection (once every 4 weeks)
Interventions
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CAN1012
CAN1012 IT injection (once every 4 weeks)
Eligibility Criteria
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Inclusion Criteria
2. Male or female age \>18 years at screening.
3. Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy.
4. Demonstrate adequate organ function as defined below. All screening laboratory assessments should be performed within 14 days of treatment initiation.
5. Performance status of 0 or 1 on the ECOG Performance Scale.
6. Life expectancy \>12 weeks at Baseline.
7. Women of childbearing potential must have negative serum pregnancy test within 3 days prior to receiving the first study drug administration.
8. For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 120 days following last day of study drug administration.
9. Male subjects of childbearing potential must be surgically sterile or must agree to use adequate method of contraception during the study and at least 120 days following the last day of study drug administration.
Exclusion Criteria
2. Has untreated or uncontrolled central nervous system (CNS) involvement.
3. Will receive concurrent chemotherapy, immunotherapy, biologic, hormonal therapy, or other therapies for cancer.
4. Received systemic interferon alfa (IFNα) prior to enrollment.
5. Unresolved toxicities from prior therapy, defined as having not resolved to CTCAE v5.0 Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
6. Treatment with systemic corticosteroids.
7. Concomitant or planned use of sensitive substrates of major cytochrome P450 enzymes.
8. Has an active infection requiring systemic therapy.
9. Has known active infection with the human immunodeficiency virus,
10. Unstable/inadequate cardiac function.
11. Uncontrolled concurrent illness.
12. A history of interstitial lung disease.
13. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
14. Participated in a clinical study of an investigational agent within 30 days of screening.
15. Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator.
16. Is pregnant or breastfeeding.
18 Years
80 Years
ALL
No
Sponsors
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CanWell Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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CanWellPharma
Woburn, Massachusetts, United States
Providence Cancer Institute
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Rongchu Chen
Role: primary
Brendan D Curti, MD
Role: primary
Other Identifiers
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CAN1012
Identifier Type: -
Identifier Source: org_study_id