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A Study of Simmitinib Plus SG001 in Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Simmitinib

    Drug

    Patients will oral administration according to study protocol until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.

  • SG001

    Drug

    Patients will receive intravenous infusion of SG001 according to study protocol until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.

Treatment groups

168 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Dose Escalation Phase Cohort 1Experimental treatment 2 interventions
Group B: Dose Escalation Phase Cohort 2Experimental treatment 2 interventions
Group C: Dose Escalation Phase Cohort 3Experimental treatment 2 interventions
Group D: Dose Expansion Phase Cohort AExperimental treatment 2 interventions
Group E: Dose Expansion Phase Cohort BExperimental treatment 2 interventions
Group F: Dose Expansion Phase Cohort CExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation Phase: Dose Limited Toxicity (DLT)

Time frame
From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)
2

Dose Escalation Phase: Maximum Tolerated Dose (MTD)

Time frame
From Cycle 1 Day 1 to Cycle 1 Day 28(each cycle is 28 days)
3

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)
4

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

Secondary outcomes

1

Plasma Concentration of simmitinib .

Time frame
Up to approximately 3 years.
2

Plasma Concentration of SG001

Time frame
Up to approximately 3 years.
3

Immunogenicity Assessments for Anti-drug Antibody

Time frame
Up to approximately 3 years.
4

Dose Escalation Phase: ORR

Time frame
Up to approximately 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: