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| Name | Class |
|---|---|
| 23andMe, Inc. | INDUSTRY |
| iTeos Therapeutics | INDUSTRY |
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This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving GSK6097608 monotherapy (Arm A) | Experimental | Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses. |
|
| Participants receiving GSK6097608 plus dostarlimab (Arm B) | Experimental | Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab. |
|
| Participants receiving dostarlimab monotherapy (Arm D) | Experimental | Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks). |
|
| Participants receiving dostarlimab plus belrestotug (Arm E) | Experimental | Participants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks. |
|
| Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F) | Experimental | Participants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK6097608 | Drug | GSK6097608 will be administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLTs) | Up to Day 21 | |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings | Up to 2 years | |
| Number of participants with dose reductions or delay | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Los Angeles | California | 90025 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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
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
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Participants will receive treatment in different dose escalation arms of the study.
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|
| Participants receiving dostarlimab plus cobolimab (Arm G) | Experimental | Participants will be administered an IV infusion of cobolimab followed by dostarlimab |
|
| Dostarlimab | Drug | Dostarlimab will be administered as an IV infusion. |
|
| Cobolimab | Drug | Cobolimab will be administered as an IV infusion. |
|
| Belrestotug | Drug | Belrestotug will be administered as an IV infusion. |
|
|
| Number of participants withdrawn due to AEs | Up to 2 years |
| Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Up to 2 years |
| Arms D, E, F, G: ORR based on modified Response Evaluation Criteria in Solid Tumors (iRECIST) | Up to 2 years |
| Arms D, E, F, G: Disease Control Rate (DCR) based on RECIST 1.1 | Up to 2 years |
| Arms D, E, F, G: DCR based on iRECIST | Up to 2 years |
| Arms D, E, F, G: Time to response (TTR) based on RECIST 1.1 | Up to 2 years |
| Arms D, E, F, G: TTR based on iRECIST | Up to 2 years |
| Arms D, E, F, G: Duration of response (DOR) based on RECIST 1.1 | Up to 2 years |
| Arms D, E, F, G: DOR based on iRECIST | Up to 2 years |
| Arms D, E, F, G: Progression-free survival (PFS) based on RECIST 1.1 | Up to 2 years |
| Arms D, E, F, G: PFS based on iRECIST | Up to 2 years |
| Arms A, B, F: Number of participants with positive anti-drug antibodies (ADAs) against GSK6097608 | Up to 2 years |
| Arms A, B, F: Titers of ADAs against GSK6097608 | Up to 2 years |
| Arms B, D, E, F, G: Number of participants with positive ADAs against dostarlimab | Up to 2 years |
| Arms B, D, E, F, G: Titers of ADAs against dostarlimab | Up to 2 years |
| Arms E, F: Number of participants with positive ADAs against belrestotug | Up to 2 years |
| Arms E, F: Titers of ADAs against belrestotug | Up to 2 years |
| Arm G: Number of participants with positive ADAs against cobolimab | Up to 2 years |
| Arm G: Titers of ADAs against cobolimab | Up to 2 years |
| Arms A, B, F: Maximum observed concentration (Cmax) for GSK6097608 | Up to 2 years |
| Arms A, B, F: Minimum observed concentration (Cmin) for GSK6097608 | Up to 2 years |
| Arms A, B, F: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for GSK6097608 | Up to 2 years |
| Arms A, B, F: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for GSK6097608 | Up to 2 years |
| Arms A, B, F: Apparent terminal phase half-life (t1/2) for GSK6097608 | Up to 2 years |
| Arms B, D, E, F, G: Cmax for dostarlimab | Up to 2 years |
| Arms B, D, E, F, G: Cmin for dostarlimab | Up to 2 years |
| Arms B, D, E, F, G: AUC(0-infinity) for dostarlimab | Up to 2 years |
| Arms B, D, E, F, G: AUC(0-t) for dostarlimab | Up to 2 years |
| Arms B, D, E, F, G: t1/2 for dostarlimab | Up to 2 years |
| Arms E, F: Cmax for belrestotug | Up to 2 years |
| Arms E, F: Cmin for belrestotug | Up to 2 years |
| Arms E, F: AUC(0-infinity) for belrestotug | Up to 2 years |
| Arms E, F: AUC(0-t) for belrestotug | Up to 2 years |
| Arms E, F: t1/2 for belrestotug | Up to 2 years |
| Arm G: Cmax for cobolimab | Up to 2 years |
| Arm G: Cmin for cobolimab | Up to 2 years |
| Arm G: AUC(0-infinity) for cobolimab | Up to 2 years |
| Arm G: AUC(0-t) for cobolimab | Up to 2 years |
| Arm G: t1/2 for cobolimab | Up to 2 years |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Houston | Texas | 77030-4009 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 1Z5 | Canada |
| GSK Investigational Site | Chiba | 277-8577 | Japan |
| GSK Investigational Site | Tokyo | 104-0045 | Japan |
| GSK Investigational Site | Seoul | 03080 | South Korea |
| GSK Investigational Site | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
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