Combining CAN1012 with PD-1 for treating advanced solid tumors

A Phase Ib/IIa, Dose Escalation, Open-Label Study of Intratumoral CAN1012 Combined With PD-1 in Patients With Unresectable or Metastatic Advanced Solid Tumors

This study is testing a new treatment combining CAN1012 with PD-1 for patients with advanced solid tumors that can't be surgically removed and who have run out of other treatment options.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Canwell Biotech Limited (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06410703 on ClinicalTrials.gov

What this trial studies

This is a Phase Ia/IIb, open-label, multicenter study evaluating the safety and efficacy of intratumoral CAN1012 combined with PD-1 in patients with unresectable or metastatic advanced solid tumors. The study focuses on patients who have exhausted standard treatment options and aims to assess the pharmacokinetics, pharmacodynamics, and potential biomarkers associated with this combination therapy. Participants will receive the treatment in a single-arm, dose escalation format to determine the optimal dosing and safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced solid tumors that are refractory or intolerant to standard therapies.

Not a fit: Patients with unresolved toxicities from prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have no remaining standard care options.

How similar studies have performed: While this approach is novel, similar combination therapies have shown promise in other studies, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent and willing to comply with the study's requirements.
2. Male or female age ≥ 18 years at screening.
3. 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.
4. 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
5. Performance status of 0-1 on the ECOG Performance Scale.

Exclusion Criteria:

1. 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.
2. Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
3. Has an active infection requiring systemic therapy.
4. Unstable/inadequate cardiac function defined as follows:

   1. New York Heart Association Class 3 or 4 congestive heart failure
   2. uncontrolled hypertension
   3. acute coronary syndrome within 6 months
   4. clinical important cardiac arrhythmia
   5. mean corrected QT (QTc) interval corrected for heart rate \>450msec（male），\>470msec（female）.
5. A history of interstitial lung disease.
6. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
7. Participated in a clinical study of an investigational agent within 30 days of screening.
8. 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.
9. Is pregnant or breastfeeding.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-Sen University Sun Yat-Sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Herui Yao, MD

Conditions Advanced Solid Tumor