CAN1012 Combined With PD-1 in Patients With Solid Tumors
- Registration Number
- NCT06410703
- Lead Sponsor
- Canwell Biotech Limited
- Brief Summary
This is a Phase Ia/IIb, open-label, first-in-human, multicenter, single-arm, dose escalation study of intratumoral CAN1012 combined with PD-1 in patients with Unresectable or Metastatic Advanced Solid Tumors who have exhausted options for standard of care therapy.
- Detailed Description
The scope of the study is to evaluate the safety of the combination therapy of CAN1012 and PD-1 in human, study its efficacy and pharmacokinetics profiles, as well as explore its pharmacodynamic effects and biomarkers.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 71
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Able and willing to provide written informed consent and willing to comply with the study's requirements.
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Male or female age ≥ 18 years at screening.
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Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists.
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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
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Performance status of 0-1 on the ECOG Performance Scale.
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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.
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Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
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Has an active infection requiring systemic therapy.
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Unstable/inadequate cardiac function defined as follows:
- New York Heart Association Class 3 or 4 congestive heart failure
- uncontrolled hypertension
- acute coronary syndrome within 6 months
- clinical important cardiac arrhythmia
- mean corrected QT (QTc) interval corrected for heart rate >450msec（male），>470msec（female）.
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A history of interstitial lung disease.
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A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
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Participated in a clinical study of an investigational agent within 30 days of screening.
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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.
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Is pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CAN1012(0.01mg)+Toripalimab(240mg) CAN1012 CAN1012(0.01mg)+Toripalimab(240mg) CAN1012(0.017mg)+Toripalimab(240mg) CAN1012 CAN1012(0.017mg)+Toripalimab(240mg)
- Primary Outcome Measures
Name Time Method Safety and tolerability 1 year Safety and tolerability as determined by assessing dose limiting toxicities, the maximum tolerated dose or maximal assessed dose per protocol in combination with toripalimab (anti-PD-1) with patients.
- Secondary Outcome Measures
Name Time Method To determine the MTD and or RP2D of CAN1012 Combined with PD-1 Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate. Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate.
To determine the Pharmacokinetics of CAN1012 Combined with PD-1 1 year Determine CAN1012 concentrations in plasma after IT administration.
Trial Locations
- Locations (1)
Sun Yat-Sen University Sun Yat-Sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China