A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-13

Study Completion Date

2026-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK4418959 alone or in combination with a PD-1 inhibitor agent can decrease tumor size, is safe, well-tolerated, and how amounts of the study drug decrease in the body over time.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

NCT06077877

Neoplasms

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Phase II Trial of HM781-36B in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of or Unfit for Platinum-containing Therapy

NCT02216916

HNSCC

UNKNOWN PHASE2

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

NCT01064479

Metastatic Squamous Cell Carcinoma of the Hypopharynx Metastatic Squamous Cell Carcinoma of the Larynx Metastatic Squamous Cell Carcinoma of the Oral Cavity +21 more

COMPLETED PHASE2

Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer

NCT06997094

Human Papillomavirus-Negative Neck Squamous Cell Carcinoma Resectable Head and Neck Squamous Cell Carcinoma Resectable Human Papillomavirus-Independent Head and Neck Mucosal Squamous Cell Carcinoma +2 more

RECRUITING PHASE1

Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer

NCT00770874

Cervical Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms, Colorectal Solid Tumor Colon Cancer Rectal Cancer Endometrial Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1: Dose escalation of GSK4418959 monotherapy

Participants will receive GSK4418959 as monotherapy.

Group Type EXPERIMENTAL

GSK4418959

Intervention Type DRUG

GSK4418959 will be administered.

Part 2: Dose expansion of GSK4418959 monotherapy

Participants will receive GSK4418959 as monotherapy.

Group Type EXPERIMENTAL

GSK4418959

Intervention Type DRUG

GSK4418959 will be administered.

Part 3: Dose escalation of GSK4418959 plus PD-1 inhibitor

Participants will receive GSK4418959 plus PD-1 inhibitor.

Group Type EXPERIMENTAL

GSK4418959

Intervention Type DRUG

GSK4418959 will be administered.

PD-1 inhibitor

Intervention Type BIOLOGICAL

PD-1 inhibitor will be administered.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GSK4418959

GSK4418959 will be administered.

Intervention Type DRUG

PD-1 inhibitor

PD-1 inhibitor will be administered.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor
* Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) status at the time of Pre-screening and MMR/MSI status will be determined by central reference laboratory
* Provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample
* Intends to receive GSK4418959 (alone or in combination with PD-1 inhibitor, as determined between Investigator and sponsor) as next line of treatment
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Is expected to have a minimum of 3 months life expectancy
* Has adequate organ function, as defined in the protocol

• Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options

* Has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC)
* Has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy
* Has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator

Exclusion Criteria

* Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced AEs
* Has received prior treatment with a WRN inhibitor
* Is unable to swallow and retain orally administered study treatment
* Has symptomatic uncontrolled brain or leptomeningeal metastases
* Has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer that is considered to be low risk for progression by the investigator
* Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs
* Has severe liver fibrosis
* Has cirrhosis or current unstable liver or biliary disease
* Has known hypersensitivity to any of the study interventions or any of their excipients
* Has known WRN syndrome
* Has an active autoimmune disease that has required systemic treatment in the past 2 years

* Has experienced any of the following with prior immunotherapy: any immune mediated adverse events (imAE) of Grade ≥3, immune-related severe neurologic events of any grade, exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug rash with eosinophilia and systemic signs syndrome \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary
* Has any history of interstitial lung disease or pneumonitis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No