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

NCT04987112 | Unknown Phase 1 FDA Drug

• 1 other identifier: CAN1012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumor; Cancer Metastatic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• PK characterization - Cmax

  12 months

• PK characterization - tmax

  12 months

• tumor size in injected lesions and non-injected lesions

  12 months

Study Arms (1)

CAN1012 single agent

EXPERIMENTAL

CAN1012 intratumoral injection given alone

Drug: CAN1012

Interventions

CAN1012 DRUG

CAN1012 IT injection (once every 4 weeks)

CAN1012 single agent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and willing to comply with the study's requirements.
• Male or female age \>18 years at screening.
• Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy.
• Demonstrate adequate organ function as defined below. All screening laboratory assessments should be performed within 14 days of treatment initiation.
• Performance status of 0 or 1 on the ECOG Performance Scale.
• Life expectancy \>12 weeks at Baseline.
• Women of childbearing potential must have negative serum pregnancy test within 3 days prior to receiving the first study drug administration.
• 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.
• 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.

You may not qualify if:

• Received prior TLR7/8 agonists (excluding topical agents).
• Has untreated or uncontrolled central nervous system (CNS) involvement.
• Will receive concurrent chemotherapy, immunotherapy, biologic, hormonal therapy, or other therapies for cancer.
• Received systemic interferon alfa (IFNα) prior to enrollment.
• 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.
• Treatment with systemic corticosteroids.
• Concomitant or planned use of sensitive substrates of major cytochrome P450 enzymes.
• Has an active infection requiring systemic therapy.
• Has known active infection with the human immunodeficiency virus,
• Unstable/inadequate cardiac function.
• Uncontrolled concurrent illness.
• A history of interstitial lung disease.
• A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
• Participated in a clinical study of an investigational agent within 30 days of screening.
• 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.

Sponsors & Collaborators

• CanWell Pharma Inc.: lead

Study Sites (2)

CanWellPharma

Woburn, Massachusetts, 02466, United States

RECRUITING

Providence Cancer Institute

Portland, Oregon, 97213, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rongchu Chen

CONTACT

+8613265001060; rongchu.chen@canwellbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 3, 2021
• Study Start: January 20, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)