What side effects are associated with this type of intervention?

Common side effects of immunotherapy treatments for solid tumors, such as those involving checkpoint inhibitors like ipilimumab, nivolumab, and pembrolizumab, include inflammation-related adverse events. These can affect various organ systems and may present as colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions like rash and pruritus. Other side effects include fatigue, diarrhea, and infusion-related reactions. Severe adverse events, though less common, can include grade 3 or 4 toxicities such as severe diarrhea, pneumonitis, and hepatitis, which may require additional immunosuppressive treatment.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumors, including immune checkpoint inhibitors such as nivolumab, pembrolizumab, and atezolizumab. These drugs target PD-1/PD-L1 pathways to enhance the immune system's ability to fight cancer. Additionally, combinations like nivolumab plus ipilimumab have been approved for various cancers, including melanoma and renal cell carcinoma. While specific TLR7 agonists like CAN1012 are still under investigation, the approval of these immunotherapies highlights the growing role of immune modulation in treating solid tumors.

What other types of research exist?

Promising novel alternatives to CAN1012 for solid tumor patients in 2024 include: <ol> <li>Chimeric Antigen Receptor (CAR)-T cell therapies, which are being tested in various solid tumors.</li> <li></li> </ol> Combination therapies involving immune checkpoint inhibitors such as nivolumab and ipilimumab, which have shown efficacy in multiple cancer types. 3. Experimental immunotherapies like nivolumab-relatlimab, which are being evaluated for their potential benefits in solid tumors. 4. Targeted therapies like cabozantinib in combination with atezolizumab, which have shown promising results in clinical trials for advanced renal cell carcinoma and other solid tumors.

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Monoclonal Antibodies

CAN1012 Injections for Cancer

Phase 1

Recruiting

Research Sponsored by CanWell Pharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Demonstrate adequate organ function as defined below. All screening laboratory assessments should be performed within 14 days of treatment initiation and include the following: Absolute neutrophil count (ANC) ≥1.5 × 109/L； Platelets ≥100 × 109/L；Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Measured or calculated creatinine clearance (CrCl) ≥ 60 mL/min Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for subjects with total bilirubin levels > 1.5× ULN； Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN OR ≤5 × ULN for subjects with liver metastases. Performance status of 0 or 1 on the ECOG Performance Scale.

Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy.

Must not have

Has an active infection requiring systemic therapy.

Has known active infection with the human immunodeficiency virus,

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests CAN1012, a drug that activates the immune system, in patients with advanced cancer who can't use standard treatments. The drug works by stimulating the immune system to fight cancer cells.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors that have worsened or don't respond to standard treatments. They must not be pregnant, agree to use contraception, and have good organ function. People with bleeding disorders, certain mental health issues, active infections including HIV, recent investigational drug use, or those on systemic steroids can't join.

What is being tested?

The study tests CAN1012 (a Selective TLR7 Agonist) given by injection directly into the tumor in patients who lack effective standard therapy options. It aims to assess its safety and how well it works against various solid tumors.

What are the potential side effects?

Potential side effects of CAN1012 are not specified here but may include typical reactions at the injection site such as pain or swelling, immune-related responses due to TLR7 activation which could affect different organs and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood tests and kidney function are within the required ranges, and I can care for myself.

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My cancer has spread or worsened despite treatment, with no effective standard options left.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have an active HIV infection.

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I am not taking drugs that are highly affected by liver enzymes.

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I have a bleeding disorder that causes uncontrolled bleeding.

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I have previously been treated with TLR7/8 agonists, not including creams or ointments.

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My brain or spinal cord cancer has not been treated or is not under control.

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I have a history of lung scarring or fibrosis.

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My heart function is stable and adequate.

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I have been treated with interferon alfa before joining this study.

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I will be getting other cancer treatments along with the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Safety and Tolerability

Secondary study objectives

PK characterization - Cmax

PK characterization - tmax

tumor size in injected lesions and non-injected lesions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CAN1012 single agentExperimental Treatment1 Intervention

CAN1012 intratumoral injection given alone

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy works by killing rapidly dividing cells, while targeted therapy blocks specific molecules involved in tumor growth and progression. Immunotherapy, such as checkpoint inhibitors and TLR agonists like CAN1012, enhances the body's immune response against cancer cells. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, leading to cell death. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment, managing expectations, and anticipating potential side effects.