JCXH-211 injections with anti-PD-1 therapy for malignant solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-phase study starting with dose-escalation to find safe JCXH-211 doses when given with an anti-PD-1 antibody, followed by dose expansion to further evaluate safety and early signals of activity. Phase I uses two dose groups to assess safety and determine the recommended dose. Phase II expands to 1–2 tumor types with 15–30 patients per cohort to explore safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy, guided by RECIST 1.1 and iRECIST criteria. All participants are monitored for safety and survival, with a data cut-off six months after the last enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients, aged 18 to 75 years;
2. patients with malignant solid tumors confirmed by pathology and/or cytology who have progressed or are intolerant to standard treatment (except best supportive care); Including patients who have received prior anti-PD-1 antibody therapy; patients who have been approved as eligible for Toripalimab:
3. General condition score ECOG 0 \~ 1;
4. Expected survival of more than 3 months;

Exclusion Criteria:

1. Known or suspected allergy to the ingredients of the study drug or its analogues; allergic history to another monoclonal antibody;
2. patients who have previously received IL-12 therapy (alone or as part of a treatment regimen), except those who have participated in tolerance to a single intratumoral injection;
3. patients who have previously received treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or have received treatment directed at another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), and discontinued treatment due to Grade 3 or higher immune-related adverse events (irAEs);

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: RuiHua Xu — Sun Yat-Sen University Cancer Center
• Study coordinator: RuiHua Xu
• Email: xurh@sysucc.org.cn
• Phone: 86-20-87343468

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.