Clinical trial · Interventional
A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Decision
Summary
Brief summary (as posted)
This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dostarlimab | Drug | Dostarlimab | ALIAS |
| GSK3745417 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort
- interventionNames
- Drug: GSK3745417
- type
- EXPERIMENTAL
- label
- Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort
- interventionNames
- Drug: GSK3745417
- Drug: Dostarlimab
Primary outcomes (7)
- measure
- Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)
- timeFrame
- Up to 21 Days
- description
- AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must be more than or equal to (\>=)18 years of age. * Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established. * Histological or cytological documentation of an advanced solid tumor. * Participants must provide a fresh biopsy. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Adequate organ function per protocol specifications. * Male or female participants. * Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception. * Capable of giving signed informed consent. Exclusion Criteria: * Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years. * Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment. * Current unstable liver or biliary disease. * History of vasculitis at any time prior to study treatment. * Evidence or history of significant active bleeding or coagulation disorder. * Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C. * QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (\>)450 milliseconds (msec) or QTcF \>480 msec for participants with bundle branch block. * Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. * Recent history of allergen desensitization therapy within 4 weeks of starting study treatment. * History or evidence of cardiovascular (CV) risk * Recent (within the past 6 months) history of symptomatic pericarditis. * History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis. * History of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions. * Prior treatment with the following agents: 1. Stimulator of Interferon Genes (STING) agonist at any time. 2. Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter. 3. Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days. 4. Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. * Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed. * Receipt of any live vaccine within 30 days of the start of study treatment. * Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. * Major surgery less than or equal to (\<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment. * Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry. * Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.
References
Publications (0)
Data not yet available