RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate CAN1012(Selective TLR7 agonist) when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.

Official Title

A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN1012 in Subjects With Unresectable or Metastatic Advanced Solid Tumors

Quick Facts

Study Start:2022-01-20

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04987112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Rongchu Chen

CONTACT

+8613265001060

rongchu.chen@canwellbiotech.com

Study Locations (Sites)

CanWellPharma

Woburn, Massachusetts, 02466

United States

Providence Cancer Institute

Portland, Oregon, 97213

United States

Collaborators and Investigators

Sponsor: CanWell Pharma Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-20

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2022-01-20

Study Completion Date2024-12-30

Terms related to this study

Additional Relevant MeSH Terms

Solid Tumor
Cancer Metastatic