Clinical trial · Interventional

One Trial of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody in Patients With Malignant Solid Tumors

A Phase I/II Clinical Trial to Evaluate the Safety and Tolerability of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody IV Infusion in Patients With Malignant Solid Tumors

NCT06781125CI-TRIAL-00106289not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is an open-label, dose-escalation and dose-expansion Phase I /II clinical study divided into Phase I and Phase II to evaluate the safety and tolerability of JCXH-211 combined with anti-PD-1 antibody in patients with malignant solid tumors.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Solid Tumors	Malignant Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Phase Ia will be planned in 2 dose groups, Phase Ib will select the optimal dose based Phase Ia
interventionNames
1. Drug: JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion

Primary outcomes (1)

measure
Dose-limiting toxicity (DLT)
timeFrame
The DLT observation period is 28 days after first dose of JCXH-211 combined with anti-PD-1 antibody

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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);

References

Publications (0)

Data not yet available

No reference posted for this study.