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

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

Detailed Description
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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.

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

Conditions
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Solid Tumor, Cancer Metastatic

Intervention / Treatment
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* Drug: CAN1012


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Is pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAN1012 single agent<br>CAN1012 intratumoral injection given alone | Drug: CAN1012<br>* CAN1012 IT injection (once every 4 weeks)<br>|

What is the study measuring?
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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 |