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Solid TumorPhase 1NCT05580991

Intratumoral CAN1012(selective TLR7 Agonist) in Subjects with Solid Tumors

A Phase 1 study testing CAN1012 in people with Solid Tumor, run by Canwell Biotech Limited at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate CAN1012 when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
CAN1012
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
9 Sep 2022to 30 Jun 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • At least one measurable lesion (RECIST 1.1)
  • At least one lesion that can receive intratumor injection multiple times
  • Performance status of 0 or 1 on the ECOG Performance Scale.
  • Life expectancy >12 weeks at Baseline.
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  • 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 × 10^9/L； Platelets >=100 × 10^9/L；Hemoglobin >=9 g/dL;
  • 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."
  • 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.
  • Able and willing to provide written informed consent and willing to comply with the study's requirements.

Who cannot join

  • Have a history of allergies in the past, and known to be allergic to CAN1012 injection or any of its components.
  • Have received TLR7/8 agonists in the past (except for topical dermal medications).
  • A history of another malignancy within the past 3 years that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone curative therapy, or in situ cervical cancer.
  • "4. Unstable/inadequate cardiac function defined as follows:
  • New York Heart Association Class 3 or 4 congestive heart failure
  • uncontrolled hypertension
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  • acute coronary syndrome within 6 months
  • clinical important cardiac arrhythmia
  • mean corrected QT (QTc) interval corrected for heart rate > 450 msec (m) or > 470 msec (md)." 5. Has known active infection with the human immunodeficiency virus, Hepatitis B(e.g., hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected), or active coronavirus disease 2019(COVID-19) infection. Note: Subjects who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate inthe study.
  • 6. Participated in a clinical study of an investigational agent within 4 weeks of screening.
  • 7. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor therapy within 4 weeks before the first administration of the research drug [among them, the following provisions are: nitrosourea (such as carmustine, lomustine, etc.) or mitomycin C is within 6 weeks before the first administration of the research drug; Oral fluorouracil, small molecule targeted drugs are 5 half-lives (whichever is longer) for 2 weeks before the first administration of the study drug or the known drug; Traditional Chinese medicines with antitumor indications are within 2 weeks before the first administration of the study drug].
  • 8. Has an active infection requiring systemic therapy within 4 weeks before the first dose of the drug under study, including but not limited to complications of infection that require hospitalization, bacteremia, severe pneumonia, etc.
  • 9. Patients with symptoms or who have undergone radiation therapy or surgery within 3 months prior to the first administration of the study (those with brain metastases and instability shall not be included).
  • 10. Injections of primary or metastatic lesions should be avoided in the central nervous system, thoracic cavity, heart and large blood vessels, liver, lungs, spleen and pancreas.
  • 11. Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
  • 12. Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
  • 13. Uncontrolled concurrent illness 14. Patients with clinically significant lung diseases in the past, including but not limited to interstitial lung disease, pulmonary fibrosis and severe radiation pneumonitis.
  • 15. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
  • 16. Concomitant or planned use of sensitive substrates of major cytochrome P450 enzymes (see Appendix 4).
  • 17. 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.
  • 18. Persons with a known history of alcohol or drug dependence. 19. Is pregnant or breastfeeding. 20. The investigator believes that the subject is unsuitable for other reasons to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Canwell Biotech Limited

    Guangzhou, Guangdong, 510535

Other trials in China

About this study

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

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

Conditions
Solid Tumor
Being tested
CAN1012

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAN1012Drug

    CAN1012 IT injection (once every 4 weeks)

Study groups in NCT05580991
Study groupRoleWhat they receive
CAN1012ExperimentalCAN1012 intratumoral injection given alone
Receives: Drug: CAN1012

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as determined by assessment of dose limiting toxicities per protocol of CAN1012 with cancers.

    Safety as determined by assessment of dose limiting toxicities per protocol of CAN1012 with cancers.

    Measured: 12 months

  2. Tolerability as determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN 1012 with cancers.

    Tolerability as determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN 1012 with cancers.

    Measured: 12 months

  3. 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 5.0)

    Measured: 12 months

  4. 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 5.0).

    Measured: 12 months

  5. PK characterization - Cmax

    Maximum observed plasma and tumor concentration of CAN1012 after IT administration.

    Measured: 12 months

  6. PK characterization - tmax

    Time to reach maximum plasma and tumor concentration of CAN1012 after IT administration.

    Measured: 12 months

  7. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start9 Sep 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580991
Sponsor's protocol ID
KW-CAN1012-101
Status last verified
Feb 2025
First submitted
10 Oct 2022
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAN1012 in people with Solid Tumor, run by Canwell Biotech Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as determined by assessment of dose limiting toxicities per protocol of CAN1012 with cancers. (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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