A Phase I/II Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 in Combination with Anti-Cancer Agents in Participants with Advanced Solid Tumors.

Conditions

Tumours, Gynecological

Brief summary

Part A (Dose Exploration) •Percentage of participants with dose limiting toxicities (DLTs) per dose level •Frequency and severity of AEs, imAEs (dostarlimab Modules), AESIs and SAEs per dose level., Part B Dose Expansion •Clinical activity measured as confirmed ORR assessed by investigator according to RECIST 1.1

Detailed description

Part A (Dose Exploration) •Clinical activity measured as confirmed ORR, DoR, and PFS by dose level assessed by investigator according to RECIST v1.1., Part A (Dose Exploration) PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload) as data permit., Part A (Dose Exploration) •Incidence of ADA, nAb and ADA titers., Part A (Dose Exploration) •Changes in vital signs, laboratory measures, ECGs, and Eastern Cooperative Oncology Group Performance Status (ECOG PS) score., Part B Dose Expansion Clinical activity measured as DoR, PFS assessed by investigator according to RECIST 1.1 and OS, Part B Dose Expansion PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload), as data permit, Part B Dose Expansion •Incidence of ADA, nAb and ADA titers., Part B Dose Expansion •Frequency and severity of AEs, imAEs (dostarlimab Modules), AESIs and SAEs per dose level •Changes in vital signs, laboratory measures, ECGs, and ECOG PS score.

Related papers

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Interventions

DRUGCarboplatino Hikma 10 mg/ml soluzione per infusione

DRUGCisplatino Accord Healthcare Italia 1 mg/ml concentrato per soluzione per infusione

DRUGJEMPERLI 500 mg concentrate for solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A (Dose Exploration) •Percentage of participants with dose limiting toxicities (DLTs) per dose level •Frequency and severity of AEs, imAEs (dostarlimab Modules), AESIs and SAEs per dose level., Part B Dose Expansion •Clinical activity measured as confirmed ORR assessed by investigator according to RECIST 1.1	—

Secondary

Measure	Time frame
Part A (Dose Exploration) •Clinical activity measured as confirmed ORR, DoR, and PFS by dose level assessed by investigator according to RECIST v1.1., Part A (Dose Exploration) PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload) as data permit., Part A (Dose Exploration) •Incidence of ADA, nAb and ADA titers., Part A (Dose Exploration) •Changes in vital signs, laboratory measures, ECGs, and Eastern Cooperative Oncology Group Performance Status (ECOG PS) score., Part B Dose Expansion Clinical activity measured as DoR, PFS assessed by investigator according to RECIST 1.1 and OS, Part B Dose Expansion PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload), as data permit, Part B Dose Expansion •Incidence of ADA, nAb and ADA titers., Part B Dose Expansion •Frequency and severity of AEs, imAEs (dostarlimab Modules), AESIs and SAEs per dose level •Changes in vital signs, laboratory measures, ECGs,	—

Measure

Time frame

Part A (Dose Exploration) •Clinical activity measured as confirmed ORR, DoR, and PFS by dose level assessed by investigator according to RECIST v1.1., Part A (Dose Exploration) PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload) as data permit., Part A (Dose Exploration) •Incidence of ADA, nAb and ADA titers., Part A (Dose Exploration) •Changes in vital signs, laboratory measures, ECGs, and Eastern Cooperative Oncology Group Performance Status (ECOG PS) score., Part B Dose Expansion Clinical activity measured as DoR, PFS assessed by investigator according to RECIST 1.1 and OS, Part B Dose Expansion PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload), as data permit, Part B Dose Expansion •Incidence of ADA, nAb and ADA titers., Part B Dose Expansion •Frequency and severity of AEs, imAEs (dostarlimab Modules), AESIs and SAEs per dose level •Changes in vital signs, laboratory measures, ECGs,

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Countries

Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed