Health TrialsbyHealthPanel

A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic 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 an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation and signature of informed consent form;

At least 18 years old, male or female;

Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;

Participants should have at least one evaluable or measurable tumor lesion;

Disqualifiers

Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;

Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;

Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening;

Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;

Trial design

Design model

Sequential

Treatments tested in this trial

  • SIM0609 for injection

    Drug

    Multiple dose levels of SIM0609 will be explored in dose escalation

  • dose expansion of SIM0609 in CRC

    Drug

    1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)

  • dose expansion of SIM0609 in GC/GEJC cohort

    Drug

    1\~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort

  • dose expansion of SIM0609 in PDAC cohort

    Drug

    1\~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort

  • dose expansion of SIM0609 in positive other solid tumors

    Drug

    1\~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort

Treatment groups

232 Participants
are divided into 5 treatment groups
Group A: A dose escalation of SIM0609Experimental treatment 1 intervention
Group B: A dose expansion of SIM0609 -CRC cohortExperimental treatment 1 intervention
Group C: A dose expansion of SIM0609-GC/GEJC cohortExperimental treatment 1 intervention
Group D: A dose expansion of SIM0609-PDAC cohortExperimental treatment 1 intervention
Group E: A dose expansion of SIM0609-positive other solid tumors cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose escalation:Dose -limiting toxicity (DLT)

Time frame
At the end of Cycle 1 (each cycle is 21/28days)
2

Dose escalation:Safety and Tolerability

Safety and tolerability: Incidence and severity of AEs and serious adverse events (SAEs) assessed by CTCAE v5.0, changes in laboratory values, vital signs, and ECGs. AE related dose interruptions, dose reduction and treatment discontinuation, dose intensity

Time frame
2 years
3

Dose escalation: 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
Apply now