A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

JRCT ID: jRCT2031220414

Registered date:26/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced Solid Tumors
• Date of first enrollment: 25/11/2022
• Target sample size: 26
• Countries of recruitment: China,Japan,Korea,Japan
• Study type: Interventional

Intervention(s)

In dose Escalation: SHR-A2009 will be administered intravenously. Nine doselevels are preset.
In dose Expansion: 3 to 4 dose cohorts will be selected for dose expansionstage.
In indication Expansion: 1 to 2 dose cohorts may be selected for indication expansion stage.

Outcome(s)

Primary Outcome

1.Maximum tolerated dose (MTD) or maximum administered dose (MAD). [Time Frame: From Day 1 to Day 21 ] Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A2009 treatment.
2.Recommended Phase 2 dose (RP2D) [ Time Frame: From Day 1 to 90 days after last dose ] RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and doseexpansion stages.
3. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0) [ Time Frame: From Day 1to 90 days after last dose ]
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1.Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which isrelapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicablecurrently;
2.Have at least one measurable tumor lesion per RECIST v1.1 (patients with only non-target lesions are allowed to beenrolled in dose escalation stage);
3.ECOG performance status of 0-1;
4.Life expectancy >=12 weeks;
5.Adequate bone marrow and organ function .
6.Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclude criteria

1.Patients with untreated or active central nervous system (CNS) metastasis. Patients with a history of meningeal metastasis or current meningeal metastasis.
2.Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
3.Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
4.History of serious cardiovascular and cerebrovascular diseases;
5.Severe infection within 4 weeks prior to the first dose;
6.Adverse reactions of previous anti-tumor treatment have not recovered to Grade=< 1 per NCI-CTCAE v5.0.

Related Information

• Primary Sponsor: Shi Wei
• Secondary ID(s): NCT05114759