Health TrialsbyHealthPanel

SIM0613 in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.

About this trial

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent (ICF) is obtained prior to any of the specified procedures required for the study

≥18 years of age

Histologically or cytologically confirmed locally advanced/metastatic solid tumors

Have at least one measurable disease per RECIST Version 1.1 criteria

Disqualifiers

Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast)

Participants with symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery), or CNS metastases requiring corticosteroids therapy within 2 weeks of first dose of study treatment.

History of bowel obstruction within 3 months prior to the first dose of study treatment.

Known psychiatric disorder or drug abuse that would interfere the study requirements

Trial design

Design model

Sequential

Treatments tested in this trial

  • SIM0613

    Drug

    Administered as an intravenous infusion in dosing cycles

  • SIM0613

    Drug

    Administered as an intravenous infusion in dosing cycles

Treatment groups

294 Participants
are divided into 2 treatment groups
Group A: A dose escalation of SIM0613Experimental treatment 1 intervention
Group B: A dose expansion of SIM0613 in several different solid tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose escalation: Safety and tolerability

Safety and tolerability：Number of participants with treatment-related adverse events as assessed by CTCAE v6.0，including laboratory values, vital signs, and electrocardiograms (ECGs), etc；AE related dose modifications(interruption, reduction and discontinuation) , etc

Time frame
2 years
2

Dose escalation：Dose -limiting toxicity (DLT)

Time frame
The first 21 days after the first dose of study treatment
3

Dose expansion：Objective response rate(ORR)

Proportion of subjects who have a complete or partial response assessed by investigator per RECIST 1.1

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Jiangsu Simcere Pharmaceutical Co., Ltd.

Lead sponsor

Shanghai Xianwei Medical Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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