Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Dostarlimab

GSK4381562

GSK4428859A

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Pamela N. Munster

Antoinette Tan

Debra L. Richardson

Anthony J Olszanski

Reva Elaine Schneider

Drew W Rasco

Vaia Florou

Samantha Bowyer

John Hilton

Lillian Siu

Ye Guo

Francois Ghiringhelli

Loic Lebellec

Toshihiko Doi

Noboru Yamamoto

Dong-Wan Kim

Byoung Chul Cho

Elena Garralda Cabanas

Victor Moreno Garcia

María José de Miguel Luken

Javier García Corbacho

Natalie Cook

Johann S De Bono

GSK Clinical Trials

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of GSK4381562 in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

3 Dose Escalation arms (Arm A: GSK4381562 alone; Arm B: GSK4381562 plus dostarlimab; Arm C: GSK4381562 plus dostarlimab plus GSK4428859A) and 1 new arm, Arm D (dostarlimab plus GSK4428859A). Additional participants may be enrolled in any study arms A, B or C in PK/Pharmacodynamic (PD) cohorts at putative recommended Phase 2 dose (RP2D) level and/or at previously cleared dose levels (up to 15 participants).

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

IPD for this study will be made available via the Clinical Study Data Request site.

Number of participants with adverse events leading to permanent discontinuation of study treatment or withdrawal from study by overall frequency will be assessed.

Overall response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.

GlaxoSmithKline

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Participants will receive \[68Ga\]Ga-DPI-4452, a single dose on Day 1.

Participants will receive a single dose of \[68Ga\]Ga-DPI-4452, at screening then escalating doses of \[177Lu\]Lu-DPI-4452, on Day 1 of each 28-cycle and RP2D will be determined.

Participants will receive a single dose of \[68Ga\]Ga-DPI-4452, at screening and RP2D dose of \[177Lu\]Lu-DPI-4452, on Day 1 of each 28-day cycle during the treatment period.

\[68Ga\]Ga-DPI-4452, administered as IV injection.

[68Ga]Ga-DPI-4452

\[177Lu\]Lu-DPI-4452, administered as IV infusion.

[177Lu]Lu-DPI-4452

Debiopharm International S.A

The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \[68Ga\]Ga-DPI-4452; Part B: is to determine the recommended phase 2 dose (RP2D) \[maximum tolerated dose (MTD) or lower dose\] for \[177Lu\]Lu-DPI-4452 for each tumor type; Part C: is to evaluate the preliminary antitumor activity of \[177Lu\]Lu-DPI-4452 as monotherapy.

A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

A Multicenter, Open-Label, Non-Randomized Phase 1/2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors

Pharmacokinetics (PK) will be evaluated in blood for radioactivity of \[68Ga\]Ga-DPI-4452.

PK will be evaluated in blood and plasma for radioactivity of \[177Lu\]Lu-DPI-4452.

PK will be evaluated in urine for radioactivity of \[68Ga\]Ga-DPI-4452 and \[177Lu\]Lu-DPI-4452.

Whole body effective dose will be calculated using the PET scan.

Debiopharm International SA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors	NCT05277051	Neoplasms	GSK4381562 Dostarlimab GSK4428859A	18 Years -	GlaxoSmithKline
A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors	NCT05706129	Clear Cell Rena... Pancreatic Duct... Colorectal Canc...	[68Ga]Ga-DPI-44... [177Lu]Lu-DPI-4...	18 Years -	Debiopharm International SA
A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors	NCT05706129	Clear Cell Rena... Pancreatic Duct... Colorectal Canc...	[68Ga]Ga-DPI-44... [177Lu]Lu-DPI-4...	18 Years -	Debiopharm International SA

Spots Global Cancer Trial Database for clear cell renal cell cancer (ccrcc)