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Monoclonal Antibodies

CAN1012 for Solid Tumors

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test a new injection to see if it helps people with advanced solid tumors who can't have standard treatment.

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.Check my eligibility
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.See study design
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
Select...
My blood tests and kidney function are within the required ranges, and I can care for myself.
Select...
My cancer has spread or worsened despite treatment, with no effective standard options left.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Safety and Tolerability
Secondary outcome measures
PK characterization - Cmax
PK characterization - tmax
tumor size in injected lesions and non-injected lesions

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAN1012 single agentExperimental Treatment1 Intervention
CAN1012 intratumoral injection given alone

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Who is running the clinical trial?

CanWell Pharma Inc.Lead Sponsor
~7 spots leftby Dec 2024
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