Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06410703

CAN1012 Combined With PD-1 in Patients With Solid Tumors

Led by Canwell Biotech Limited · Updated on 2024-10-31

71

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CAN1012 Combined With PD-1 in Patients With Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide written informed consent and comply with study requirements
  • Male or female age 18 years or older at screening
  • Histologically and cytologically confirmed locally advanced or metastatic solid tumors refractory or intolerant to standard therapies or without standard therapy
  • Metastatic or locally advanced solid tumor progressed on, refractory to, or with no efficacious standard therapy; preferred tumor types include skin carcinoma, melanoma, Merkel cell carcinoma, breast cancer, head and neck squamous cell carcinoma, sarcoma, cervical carcinoma, and colorectal cancer
  • Performance status of 0-1 on the ECOG Performance Scale
Not Eligible

You will not qualify if you...

  • Unresolved toxicities from prior therapy not resolved to CTCAE v5.0 Grade 0 or 1 except endocrinopathies, alopecia, and vitiligo
  • Treatment with systemic corticosteroids exceeding 10 mg/day prednisone or equivalent
  • Active infection requiring systemic therapy
  • Unstable or inadequate cardiac function including NYHA Class 3 or 4 heart failure, uncontrolled hypertension, acute coronary syndrome within 6 months, important cardiac arrhythmias, or QTc interval >450 msec (male) or >470 msec (female)
  • History of interstitial lung disease
  • History of coagulopathy causing uncontrolled bleeding or other bleeding disorders
  • Participation in another investigational agent clinical study within 30 days of screening
  • Known psychiatric, substance abuse, or other disorders interfering with study cooperation
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 1 location

1

Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China, 510535

Actively Recruiting

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Research Team

H

Herui Yao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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CAN1012 Combined With PD-1 in Patients With Solid Tumors | DecenTrialz