A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors

NCT06431594 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2227302024-513860-25
• Study Type: interventional
• Target: 385
• Locations: 14 countries
• Sites: 47

Brief Summary

The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.

Conditions

Solid Tumors; Neoplasms

Keywords

Solid Tumors; GSK5733584

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of participants with dose limiting toxicity (DLT)

  Up to 21 days

• Part 2: Confirmed Objective Response Rate (ORR)

  ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  Up to approximately 28 months

Secondary Outcomes (39)

• Part 1 and 2: Maximum observed concentration (Cmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin

  Up to approximately 31 months

• Part 1 and 2: Time to reach Cmax (Tmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin

  Up to approximately 31 months

• Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin

  Up to approximately 31 months

• Part 1: Confirmed Objective Response Rate (ORR)

  Up to approximately 31 months

• Part 1 and 2: Duration of response (DoR)

  Up to approximately 31 months

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Participants with advanced solid tumors who are refractory or intolerant to established standard therapies

Drug: GSK5733584

Part 2: Dose Expansion

EXPERIMENTAL

Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)

Drug: GSK5733584

Interventions

GSK5733584 DRUG

GSK5733584 will be administered

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 years or older (≥18 years).
• Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
• PROC cohort
• Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
• Must have received or are intolerant to 1 but no more than 3 lines of prior systemic therapy.
• Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.
• Must have had prior bevacizumab if the participant was considered a candidate for this regimen and the regimen is locally available.
• Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtasine if the participants was considered a candidate for this regimen and the regimen is locally available.
• Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the participant was considered a candidate for this regimen and the regimen is locally available.
• Endometrial cancer cohort
• Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer.
• Must have received or are intolerant to 1 but no more than 3 lines of prior systemic therapy.
• Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if considered a candidate for this regimen and the regimen is locally available.
• All epithelial histologies are permitted including carcinosarcoma.
• Participants have at least one target lesion as assessed per the RECIST 1.1

You may not qualify if:

• Have received any of B7-H4-targeted therapies.
• Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
• Have 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 treatment.
• Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
• Major surgery within 28 days prior to the first dose of study treatment.
• Evidence of brain metastasis unless asymptomatic.
• Has inadequate bone marrow reserve or hepatic/renal functions.
• Mean Fridericia-corrected QT interval (QTcF) \> 470 millisecond (msec) on resting ECG.
• Evidence of current clinically significant arrhythmias or ECG abnormalities
• Risk factors of prolonged QTc or arrhythmia events,
• Left ventricular ejection fraction (LVEF) \< 50%.
• Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
• Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
• Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)
• PROC

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (47)

GSK Investigational Site

Lake Mary, Florida, 32746, United States

RECRUITING

GSK Investigational Site

Fairway, Kansas, 66205, United States

RECRUITING

GSK Investigational Site

Boston, Massachusetts, 02114, United States

RECRUITING

GSK Investigational Site

Boston, Massachusetts, 02215, United States

RECRUITING

GSK Investigational Site

Detroit, Michigan, 48201, United States

RECRUITING

GSK Investigational Site

Grand Rapids, Michigan, 49546, United States

RECRUITING

GSK Investigational Site

Nashville, Tennessee, 37203, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75230, United States

RECRUITING

GSK Investigational Site

West Valley City, Utah, 84119, United States

RECRUITING

GSK Investigational Site

Cipoletti Rio Negro, R8324CVE, Argentina

RECRUITING

GSK Investigational Site

Ciudad de Buenos Aires, 1118, Argentina

RECRUITING

GSK Investigational Site

Rosario, S2002, Argentina

RECRUITING

GSK Investigational Site

Blacktown, New South Wales, 2148, Australia

RECRUITING

GSK Investigational Site

Macquarie University, New South Wales, 2109, Australia

RECRUITING

GSK Investigational Site

Leuven, 3000, Belgium

RECRUITING

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

GSK Investigational Site

Helsinki, 00180, Finland

RECRUITING

GSK Investigational Site

Helsinki, 00290, Finland

RECRUITING

GSK Investigational Site

Tampere, 33520, Finland

RECRUITING

GSK Investigational Site

Lyon, 69373, France

RECRUITING

GSK Investigational Site

Saint-Herblain, 44805, France

RECRUITING

GSK Investigational Site

Villejuif, 94805, France

RECRUITING

GSK Investigational Site

Roma, 00168, Italy

RECRUITING

GSK Investigational Site

Rozzano MI, 20089, Italy

RECRUITING

GSK Investigational Site

Saitama, 350-1298, Japan

RECRUITING

GSK Investigational Site

Shizuoka, 411-8777, Japan

RECRUITING

GSK Investigational Site

Tokyo, 135-8550, Japan

RECRUITING

GSK Investigational Site

Amsterdam, 1066 CX, Netherlands

RECRUITING

GSK Investigational Site

Gyeonggi-do, 10408, South Korea

RECRUITING

GSK Investigational Site

Seoul, 03080, South Korea

RECRUITING

GSK Investigational Site

Seoul, 03722, South Korea

RECRUITING

GSK Investigational Site

Seoul, 06351, South Korea

RECRUITING

GSK Investigational Site

Barcelona, 08035, Spain

RECRUITING

GSK Investigational Site

Córdoba, 14004, Spain

RECRUITING

GSK Investigational Site

Girona, 17007, Spain

RECRUITING

GSK Investigational Site

Madrid, 28027, Spain

RECRUITING

GSK Investigational Site

Madrid, 28034, Spain

RECRUITING

GSK Investigational Site

Madrid, 28040, Spain

RECRUITING

GSK Investigational Site

Madrid, 28046, Spain

RECRUITING

GSK Investigational Site

Pozuelo de AlarcOn Madr, 28223, Spain

RECRUITING

GSK Investigational Site

Stockholm, 17164, Sweden

RECRUITING

GSK Investigational Site

Uppsala, SE-751 85, Sweden

RECRUITING

GSK Investigational Site

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

GSK Investigational Site

London, NW1 2PG, United Kingdom

RECRUITING

GSK Investigational Site

London, W1G 6AD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

ES (8); SE (2); GB (3); FI (3); AU (2); IT (2); JP (3); AR (3); CA (3); BE (1); US (9); FR (3); NL (1); KR (4)