Clinical trial · Interventional

SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

NCT07622225CI-TRIAL-00113494not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study is a Phase Ib/II clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced 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
Advanced Solid Tumors	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Enlonstobart	Biological	—	UNRESOLVED
SYS6006	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
SYS6006 + Enlonstobart
description
Phase Ib Dose Escalation Cohort Dose level 1 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart. Dose level 2 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart. 1. If 0/3 participants experience a DLT, the next 3 participants can be enrolled to receive the same dose regimen, and escalation to the next dose group may proceed; 2. If 1/3 participants experience a DLT, an additional 3 participants will be enrolled to continue evaluation at the same dose regimen: If a final total of 1/6 participants experience a DLT, escalation to the next dose group may proceed; If ≥2 of the 6 evaluable participants experience a DLT, escalation will be stopped; 3. If ≥2/3 participants experience a DLT, escalation will be stopped. Phase II Investigational Treatment:The maximum safe dose of SYS6006 in combination Enlonstobart (as determined in the phase Ib cohort).
interventionNames
1. Biological: SYS6006
2. Biological: Enlonstobart
type
ACTIVE_COMPARATOR
label
Enlonstobart
description
Phase II Investigational Treatment:Enlonstobart Intravenous infusion
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 1\. Able to understand and voluntarily sign the written informed consent form (ICF);
* 2\. Male or female subjects aged over 18 years old (inclusive).
* 3\. Patients with solid tumor who have unresectable locally advanced or metastatic disease;
* 4\. At least one measurable lesion, as defined by RECIST 1.1 criteria;
* 5\. ECOG performance status of 0-2;
* 6\. Expected survival ≥ 3 months;
* 7\. Adequate function of major organs and bone marrow;
* 8\. Women or man of childbearing potential must use highly effective contraception.

Exclusion Criteria:

* 1\. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
* 2\. Patients with a history of autoimmune diseases;
* 3\. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
* 4\. Severe or uncontrolled cardiovascular disorder requiring treatment;
* 5\. Women who are pregnant or breastfeeding.

References

Publications (0)

Data not yet available

No reference posted for this study.