Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

NCT06682611 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2024-11-12

No results posted yet for this study

Summary

This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.

Conditions

  • Unresectable Locally Advanced or Metastatic Solid Tumors

Interventions

DRUG

SYHA1813

In accordance with the protocol

DRUG

SG001

In accordance with the protocol

DRUG

HB1801

In accordance with the protocol

DRUG

Carboplatin

In accordance with the protocol

DRUG

Cisplatin

In accordance with the protocol

DRUG

Paclitaxel

In accordance with the protocol

DRUG

Etoposide

In accordance with the protocol

DRUG

Everolimus

In accordance with the protocol

DRUG

Regorafenib

In accordance with the protocol

Sponsors & Collaborators

  • Shanghai Runshi Pharmaceutical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2026-11-13
Completion
2027-11-13

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682611 on ClinicalTrials.gov