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

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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Cancer Metastatic
• Intervention / Treatment: Drug: CAN1012

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rongchu Chen; Phone Number: +8613265001060; Email: rongchu.chen@canwellbiotech.com

Study Locations

• United States
  • Massachusetts
    • Woburn, Massachusetts, United States, 02466
      • Recruiting
      • CanWellPharma
      • Contact: Rongchu Chen; Email: rongchu.chen@canwellbiotech.com
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Providence Cancer Institute
      • Contact: Brendan D Curti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAN1012 single agent; CAN1012 intratumoral injection given alone	Drug: CAN1012; CAN1012 IT injection (once every 4 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK characterization - Cmax	Maximum observed plasma and tumor concentration of CAN1012 after IT administration.	12 months
PK characterization - tmax	Time to reach maximum plasma and tumor concentration of CAN1012 after IT administration.	12 months
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

Collaborators and Investigators

• Sponsor: CanWell Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CAN1012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No