Solid TumorPhase 1NCT06332430
Intratumoral CAN2109 in Subjects With Solid Tumors
A Phase 1 study testing CAN2109 in people with Solid Tumor and Lymphoma, run by Canwell Biotech Limited at 1 site in China.
Trial summary
A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- CAN2109
- 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
- 28 May 2024to 30 May 2026
- 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
- 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. Preferred tumor types include the following:
- Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer
- Performance status of 0-1 on the ECOG Performance Scale.
Who cannot join
- 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.
- Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
- Has an active infection requiring systemic therapy.
- Unstable/inadequate cardiac function defined as follows:
- New York Heart Association Class 3 or 4 congestive heart failure
- uncontrolled hypertension
Show all 14Show fewer
- acute coronary syndrome within 6 months
- clinical important cardiac arrhythmia
- mean corrected QT (QTc) interval corrected for heart rate > 480 ms.
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510535
Herui Yao, Professor
About this study
Official title: A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN2109 in Subjects With Unresectable or Metastatic Advanced Solid Tumors.
A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.
Read the detailed description
The scope of the study is to evaluate the safety of CAN2109 in humans, explore its safety, efficacy and collect data on the pharmacokinetics, as well as on the pharmacodynamic effect of the drug on the immune system locally and systemically, and on tumor markers.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- CAN2109
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN2109Drug
CAN2109 IT injection (once every 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| CAN2109 | Experimental | CAN2109 IT injection every three weeks (Q3W) Receives: Drug: CAN2109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers.
Measured: 12 months
Recommended Phase 2 Dose (RP2D)
To determine a recommended phase 2 dose of CAN21909 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
tolerability
determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers.
Measured: 12 months
Secondary outcomes (2)
To determine the efficacy of CAN2109
Proportion of patients experiencing a tumor response or a stable disease according to RECIST 1.1 or iRECIST 1.1 as appropriate.
Measured: 12 months
To evaluate the pharmacodynamics of CAN2109
Maximum observed plasma and tumor concentration of CAN2109 after IT administration.
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 posted27 Mar 2024
- Study start28 May 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2026 (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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canwell Biotech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332430
- Sponsor's protocol ID
- CW-202
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. 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 CAN2109 in Subjects With Unresectable or Metastatic Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06332430
- Acronym / sponsor ID
- CW-202
- Conditions
- Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Canwell Biotech LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 27 Mar 2024 (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.
A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.
Detailed description
The scope of the study is to evaluate the safety of CAN2109 in humans, explore its safety, efficacy and collect data on the pharmacokinetics, as well as on the pharmacodynamic effect of the drug on the immune system locally and systemically, and on tumor markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAN2109 | Experimental | Drug: CAN2109CAN2109 IT injection every three weeks (Q3W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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. Preferred tumor types include the following:
- Performance status of 0-1 on the ECOG Performance Scale.
Key exclusion criteria (14 listed)
- 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.
- Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
- Has an active infection requiring systemic therapy.
- Unstable/inadequate cardiac function defined as follows:
- A history of interstitial lung disease.
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 |
|---|---|---|
| CAN2109CAN2109 IT injection (once every 3 weeks) | Drug | CAN2109 |
Primary outcome
Safety
Time frame: 12 months
determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers.
Recommended Phase 2 Dose (RP2D)
Time frame: 12 months
To determine a recommended phase 2 dose of CAN21909 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).
tolerability
Time frame: 12 months
determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers.
2 secondary outcomes
To determine the efficacy of CAN2109
Time frame: 12 months
To evaluate the pharmacodynamics of CAN2109
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAN2109 in people with Solid Tumor and Lymphoma, 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. 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?
Contact Herui Yao, MD (+86 020-34070412, yaoherui@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (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 19 Dec 2024.