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A Phase 1, open-label, multicenter study of GSK5533524 alone or in combination with other anti-cancer agents, in adult participants with selected advanced solid tumors

FTIH study to investigate the safety and preliminary activity of GSK5533524 alone or in combination in adult participants with advanced solid tumors

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Pending

Mar. 31, 2026

Interventional

single arm study

open(masking not used)

dose comparison control

single assignment

treatment purpose

-Is at least 18 years of age or the legal age of consent
-Has histologically or cytologically confirmed advanced/metastatic solid tumor that is refractory to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care therapies.
-Has documented disease progression based on radiologic imaging, during or after most recent line of treatment.
-Has at least one target lesion per RECIST 1.1 (participants in Part 1a backfill and Part 1b).
-Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and no deterioration in the 2 weeks before enrollment.
-Has adequate organ function.

-Has a history of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure or clinically significant arrhythmia not controlled by Standard of care therapy.
-Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion.
-Has untreated brain or central nervous system metastases or metastases that have progressed
-Has a Grade >-2 corneal epithelial condition.
-Has any active renal condition
-Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
-Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to <-Grade 1 or to the baseline status preceding prior therapy.
-Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis.
-Has a lung-specific intercurrent clinically significant illness
-Has FEV1 <50% predicted
-Has chronic enteritis or inflammatory bowel disease or any history of clinically significant bleeding of gastrointestinal tract or clinically significant obstruction and/or perforation and/or fistulae of GI tract.
-Has a known hypersensitivity to any component of GSK5533524 or its excipients.
-Has history of severe allergies, or severe infusion related reactions, or idiosyncrasy to recombinant humanized proteins.
-Has received any MUC16 targeted therapies.
-Has received prior therapy with TOPO1i or TOPO1i ADCs.
-Has received any cytotoxic chemotherapy drugs, or other anti-tumor drugs within 28 days prior to the first dose of study drug.
-Has received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study intervention.
-Has received immunosuppressive agents or required long-term glucocorticoid therapy within 30 days prior to first dose of study treatment.
-Has corrected QT interval by Fridericia formula (QTcF) >450 msec or QTcF >480 msec for participants with bundle branch block.
-Has a left ventricular ejection fraction (LVEF) < 50%.

Both

Part1a: Platinum-resistant ovarian cancer
Part1b: Endometrial Cancer, Lung adenocarcinoma

Part1a: GSK5533524 monotherapy will be administered intravenously at different dose levels every 21 days based on the dose-escalation study design.
Part1b: Dose of GSK5533524 monotherapy determined by Part1a results intravenously every 21 days.

Part1a:
-Incidence of dose-limiting toxicities per dose level
-Incidence and severity of AEs and SAEs per dose level

Part1b:
-ORR assessed by investigator according to RECIST 1.1

Part1a:
-Incidence and severity of AEs, SAEs, TEAEs, AESIs, and AEs leading to dose modifications and treatment discontinuation
-ORR and DoR assessed by investigator according to RECIST 1.1
-PK concentrations up to and including Cycle 3 for GSK5533524 and its components: conjugated antibody, total antibody, and payload
-Incidence of ADA and ADA titers

Part1b:
-Incidence and severity of AEs, SAEs, TEAEs, AESIs, and AEs leading to dose modifications, and treatment discontinuation
-DoR assessed by investigator according to RECIST 1.1
-PK concentrations up to and including Cycle 3 of GSK5533524 and its components: conjugated antibody, total antibody, and payload
-Incidence of ADA and ADA titers

No

US/Canada/France/Spain/UK/Finland/Denmark