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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987112
• Other study ID #: CAN1012
• Status: Recruiting
• Phase: Phase 1
• Start date: January 20, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: CanWell Pharma Inc.
• Contact: Rongchu Chen
• Phone: +8613265001060
• Email: rongchu.chen[@]canwellbiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a Phase 1, open-label, first-in-human, single-arm, multicenter, dose escalation study of IT CAN1012 in subjects with advanced solid tumors who are not candidates for standard therapy. Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 (IFNa) 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.

Related Conditions & MeSH terms

• Cancer Metastatic
• Neoplasms
• Solid Tumor

Intervention

Drug:
• CAN1012
CAN1012 IT injection (once every 4 weeks)

Locations

Country	Name	City	State
United States	Providence Cancer Institute	Portland	Oregon
United States	CanWellPharma	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CanWell Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Safety and tolerability as determined by assessment of dose limiting toxicities and the maximum tolerated dose or maximal assessed dose per protocol of CAN1012 with cancers.	12 months
Primary	Recommended Phase 2 Dose (RP2D)	To determine a recommended phase 2 dose of CAN1012 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)	12 months
Primary	Maximum Tolerated Dose (MTD)	Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0).	12 months
Secondary	PK characterization - Cmax	Maximum observed plasma and tumor concentration of CAN1012 after IT administration.	12 months
Secondary	PK characterization - tmax	Time to reach maximum plasma and tumor concentration of CAN1012 after IT administration.	12 months
Secondary	tumor size in injected lesions and non-injected lesions	Changes in tumor size using computed tomography (CT) scan or magnetic resonance imaging (MRI) scan assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	12 months