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First in Human Study of SIM0610 in Solid Tumors

ConditionsAdvanced Solid TumoursNon-Small Cell Lung CancerColorectal CancerHead and Neck Squamous Cell CarcinomaHepatocellular Carcinoma
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, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate and sign the informed consent form

At least 18 years old, male or female

Subjects with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;

Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or other local treatments cannot be used as target lesions unless there is clear progression of the lesion)

Disqualifiers

A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of recurrence as assessed by the investigator.

Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local therapy (e.g., radiotherapy or surgery) for CNS metastases; or requirement for corticosteroid therapy for CNS metastases.

A history of non-infectious interstitial lung disease (ILD)/pulmonary inflammation requiring corticosteroid treatment; current ILD/pulmonary inflammation; or suspected ILD/pulmonary inflammation that cannot be ruled out by screening imaging.

Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SIM0610 for Injection

    Drug

    intravenous infusion

  • SIM0610 for Injection

    Drug

    intravenous infusion

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Dose escalationExperimental treatment 1 intervention
Group B: Cohort expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity (DLT)

Time frame
From time of first dose of SIM0610 to end of DLT period (approximately 21 days)
2

Safety and Tolerability

Time frame
From time of Informed Consent to 28 days post last dose of SIM0610
3

Objective response rate (ORR)

Objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
From date of first dose of SIM0610 up until progression, or the last evaluable assessment in the absence of progression (approximately 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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