RecruitingPhase 1

A Study of SKB315 in Patients With Advanced Solid Tumors

China246 participantsStarted 2022-03-16

Plain-language summary

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18 to 80 years old (including boundary values);
✓. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction 3 positive CLDN18.2 expression in tumor tissue;

Exclusion criteria

✕. HER2 expression in tumor tissue is positive.
✕. Has a history of brain metastases.
✕. Additional malignancy within the five years prior to the first administration.
✕. Has an active autoimmune disease or a history of autoimmune disease.
✕. Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration.
✕. A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.
✕. In the investigator's judgment, the subjects has other factors that could have affected the study results or led to the forced termination of the study.

What they're measuring

Phase 1a: Dose Limiting Toxicities (DLT)

Timeframe: From data of initial dose until up to 21/28 days for treatment

Phase 1b: Objective Response Rate (ORR)

Timeframe: Up to 2 years

Trial details

NCT IDNCT05367635

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Yi Ba, Professor

022-23340123 bayi@tjmuch.com

View on ClinicalTrials.gov More Advanced Solid Tumors trials