Solid TumorPhase 1NCT04987112
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors
A Phase 1 study testing CAN1012 in people with Solid Tumor and Cancer Metastatic, run by CanWell Pharma Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Cancer Metastatic
- 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
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jan 2022to 30 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Providence Cancer Institute
Portland, Oregon, 97213
Brendan D Curti, MD
- Recruiting
CanWellPharma
Woburn, Massachusetts, 02466
Rongchu Chen, rongchu.chen@canwellbiotech.com
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(Selective TLR7 agonist) when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.
Read the detailed description
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.
- Conditions
- Solid Tumor, Cancer Metastatic
- Being tested
- CAN1012
- Medical subject headings
- Neoplasm Metastasis
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 group | Role | What they receive |
|---|---|---|
| CAN1012 single agent | Experimental | CAN1012 intratumoral injection given alone Receives: Drug: CAN1012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: 12 months
Secondary outcomes (3)
PK characterization - Cmax
Maximum observed plasma and tumor concentration of CAN1012 after IT administration.
Measured: 12 months
PK characterization - tmax
Time to reach maximum plasma and tumor concentration of CAN1012 after IT administration.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start20 Jan 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanWell Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987112
- Sponsor's protocol ID
- CAN1012
- Status last verified
- Dec 2023
- First submitted
- 9 Jul 2021
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN1012 in Subjects With Unresectable or Metastatic Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04987112
- Acronym / sponsor ID
- CAN1012
- Conditions
- Solid Tumor, Cancer Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- CanWell Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAN1012 single agent | Experimental | Drug: CAN1012CAN1012 intratumoral injection given alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAN1012CAN1012 IT injection (once every 4 weeks) | Drug | CAN1012 single agent |
Primary outcome
Safety and Tolerability
Time frame: 12 months
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.
Recommended Phase 2 Dose (RP2D)
Time frame: 12 months
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)
Maximum Tolerated Dose (MTD)
Time frame: 12 months
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).
3 secondary outcomes
PK characterization - Cmax
Time frame: 12 months
PK characterization - tmax
Time frame: 12 months
tumor size in injected lesions and non-injected lesions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAN1012 in people with Solid Tumor and Cancer Metastatic, run by CanWell Pharma Inc. at 2 sites in United States.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongchu Chen (+8613265001060, rongchu.chen@canwellbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2023.