Clinical Trials/NCT06132217

NCT06132217

Not yet recruiting

Phase 1

A Phase I/II Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Simmitinib Plus SG001 in Patients With Advanced Solid Tumors

Shanghai Runshi Pharmaceutical Technology Co., Ltd1 site in 1 country168 target enrollmentJanuary 30, 2024

ConditionsAdvanced Solid Tumor

InterventionsSimmitinib SG001

Overview

Phase: Phase 1
Intervention: Simmitinib
Conditions: Advanced Solid Tumor
Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd
Enrollment: 168
Locations: 1
Primary Endpoint: Dose Escalation Phase: Dose Limited Toxicity (DLT)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I.

Registry

clinicaltrials.gov

Start Date

January 30, 2024

End Date

January 30, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have fully understood and voluntarily sign the ICF for this study;
•Age of 18-75 years (inclusive);
•Dose escalation phase: patients with histologically or cytologically confirmed inoperable or metastatic advanced solid tumors;
•Dose expansion phase: patients who have failed standard treatment (PD or intolerable toxicity after treatment), have no available standard treatment.According to the previous data, the specific tumor cohort was expanded.
•In the expansion phase, patients should agree to provide tissue specimens for detection of PD-L1 expression levels and/or MSI or dMMR status;
•At least one measurable lesion according to RECIST 1.1;
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
•Adequate organ function, defined as:
•Neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 100× 10\^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN; Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio(INR)≤1.5 × ULN; Thyroid Stimulating Hormone (TSH)≤ULN; Left ventricular ejection fraction (LVEF)≥50%; Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.

Exclusion Criteria

•Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
•Urine protein ≥ ++ and 24 h urine protein \> 1.0g at screening period;
•Symptomatic central nervous system (CNS) metastases or meningeal metastases;
•Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;
•History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma;
•Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;
•Patients with any active autoimmune disease requiring systemic therapy within 2 years prior to the first dose;
•Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;
•Presence of any severe and/or uncontrolled disease before starting treatment;
•Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;

Arms & Interventions

Dose Escalation Phase Cohort 1

Intervention: Simmitinib

Dose Escalation Phase Cohort 1

Intervention: SG001

Dose Escalation Phase Cohort 2

Intervention: Simmitinib

Dose Escalation Phase Cohort 2

Intervention: SG001

Dose Escalation Phase Cohort 3

Intervention: Simmitinib

Dose Escalation Phase Cohort 3

Intervention: SG001

Dose Expansion Phase Cohort A

Intervention: Simmitinib

Dose Expansion Phase Cohort A

Intervention: SG001

Dose Expansion Phase Cohort B

Intervention: Simmitinib

Dose Expansion Phase Cohort B

Intervention: SG001

Dose Expansion Phase Cohort C

Intervention: Simmitinib

Dose Expansion Phase Cohort C

Intervention: SG001

Outcomes

Primary Outcomes

Dose Escalation Phase: Dose Limited Toxicity (DLT)

Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)

Dose Expansion Phase - Objective Response Rate (ORR) evaluated by Independent Review Committee (IRC) or investigators in advanced solid tumor based on RECIST 1.1.

Time Frame: Up to approximately 3 years.

Dose Escalation Phase: Recommended Phase 2 Dose (RP2D)

Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)

Dose Escalation Phase: Maximum Tolerated Dose (MTD)

Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)

Dose Escalation Phase-Incidence rate of Adverse Event (AE).

Time Frame: From first dose to 30 days post the last dose, with approximately 3 years