Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors

Launched by CANWELL PHARMA INC. · Jul 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CAN1012, which is given as an injection directly into tumors for patients with advanced solid tumors, including cancers that have spread and for which standard treatments aren’t working. The goal is to see how well this treatment works and if it can help patients who have few other options available.

To participate in this trial, you need to be over 18 years old and have a specific type of cancer that has either not responded to other treatments or for which there are no effective standard therapies left. You must also be in good enough health to safely receive the treatment and have a life expectancy of at least 12 weeks. Participants will be monitored closely throughout the study, and women who can become pregnant will need to use birth control during and after the trial. Overall, this trial offers a potential new option for patients facing difficult cancer situations, and the research team is looking for volunteers who meet the criteria to help advance cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able and willing to provide written informed consent and willing to comply with the study's requirements.
• • 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:
• • 1. Received prior TLR7/8 agonists (excluding topical agents).
• • 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.