GSK3901961 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
GSK Investigational Site, Amsterdam, Netherlands
GSK3901961 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a type of white blood cell may help treat cancer.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether GSK3901961 will improve 4 primary outcomes and 14 secondary outcomes in patients with Cancer. Measurement will happen over the course of Until disease progression (up to 4 years).

Year 4
Substudy 1 and 2: Area under the concentration/persistence time curve from zero to time t (AUC[0-t])
Substudy 1 and 2: Duration of response (DOR)
Substudy 1 and 2: Frequency of dose limiting toxicities (DLTs) according to severity.
Substudy 1 and 2: Maximum expansion/persistence (Cmax)
Substudy 1 and 2: Overall response rate (ORR)
Substudy 1 and 2: Phenotype of transduced T cells
Substudy 1 and 2: Time to Cmax (Tmax)
Substudy 1 and 2:Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity
Substudy 1, 2 and 3 : Time to Cmax (Tmax)
Substudy 1, 2 and 3: Area under the concentration/persistence time curve from zero to time t (AUC[0-t])
Substudy 1, 2 and 3: Duration of response (DOR)
Substudy 1, 2 and 3: Frequency of dose limiting toxicities (DLTs)
Substudy 1, 2 and 3: Maximum expansion/persistence (Cmax)
Substudy 1, 2 and 3: Overall response rate (ORR)
Substudy 1, 2 and 3:Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity
Substudy 2: Disease control rate (DCR)
Substudy 2: Progression free survival (PFS)
Substudy 2: Time to response

Trial Safety

Safety Estimate

1 of 3

Trial Design

7 Treatment Groups

No Control Group
Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS

This trial requires 50 total participants across 7 different treatment groups

This trial involves 7 different treatments. GSK3901961 is the primary treatment being studied. Participants will be divided into 7 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Substudy 3: GSK4427296 in previously treated advanced SS or MRCLSEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLSEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy.
Substudy 2: GSK3845097 in previously treated advanced SS or MRCLSEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy.
Substudy 1: GSK3901961 in previously treated advanced SSEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy.
Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLCEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy.
Substudy 2: GSK3845097 in previously treated advanced SSEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as a single IV infusion after completing lymphodepleting chemotherapy.
Substudy 1: GSK3901961 in previously treated metastatic NSCLCEligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as a single IV infusion after completing lymphodepleting chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until disease progression (up to 4 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly until disease progression (up to 4 years) for reporting.

Closest Location

GSK Investigational Site - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must have adequate organ function and blood cell counts 7 days prior to leukapheresis. show original
You are 18 years of age or older. show original
Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles
Participant's tumor must have tested positive for NY-ESO-1/ LAGE-1a expression by a GSK designated laboratory
You have performance status of 0-1. show original
Participant must have measurable disease according to RECIST v1.1.
Participant has advanced (metastatic or unresectable) synovial sarcoma or MRCLS confirmed by local histopathology with evidence of disease-specific translocation
Participant has received/completed treatment with anthracycline or with ifosfamide if intolerant to anthracycline for advanced (metastatic or unresectable) disease and progressed
Participant has Stage IV NSCLC as confirmed by histology or cytology
Participant has been previously treated with or is intolerant to programmed death receptor-1 (PD)-1/Programmed death ligand 1 (PD-L1) checkpoint blockade therapy. For NSCLC that harbors an actionable genetic aberration (BRAF, anaplastic lymphoma kinase [ALK]/ c-ros oncogene 1 [ROS1]) per National Comprehensive Cancer Network (NCCN) guidelines, participant has also been previously treated with or is intolerant to the standard of care targeted therapy as recommended by NCCN or equivalent country-level guidelines (European Society for Medical Oncology [ESMO], National Institute for Health & Care Excellence [NICE])

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cancer?

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What are the specific causes of cancer? The most important factors include genetic predisposition, environmental exposures such as ionizing radiation from radiation therapy, viral, bacterial or parasitic infection, and cigarette smoking. Tobacco smoking is the number one cause of cancer worldwide, responsible for approximately 36% of deaths in developed countries and 50-60% of cancer cases in developing countries. In 2012 about 16.7 million cancer deaths (about 3.8 million cancer related deaths) were reported to the World Health Organization. This means about one person dies of cancer every minute, and about 870,000 people in the United States will have cancer the year they die, making cancer the most frequent cause of death. There are many types of cancer.

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How many people get cancer a year in the United States?

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An estimated 2 million cases of cancer are diagnosed each year. The majority (70%) are non-melanoma skin cancers. Nearly half (42%) of all cancer diagnoses, and one-third of all cancer deaths are attributed to cigarette smoking, the second most common single modifiable risk factor after diet and alcohol. In the US in 2006 (the most recent year for which data are available), the age-adjusted rate per 100,000 population of cancer is as follows: lung cancer, 2.1; colon cancer, 8.4; prostate cancer, 12.4; breast cancer, 16.6; and other cancers, 26.7.

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What are the signs of cancer?

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Sometimes the symptoms are so strong that they interfere with daily activities. For instance, unexplained weight loss can be an early warning sign for cancer. Other signs include itchiness (scabies), night sweats, swollen lymph nodes, swelling in the neck (gland cancer), bleeding into a wound or nose (cancer of the esophagus or nasopharynx) and a red swelling behind the ear (cancer of the thyroid or cancer of the parathyroid gland).

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What is cancer?

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Cancer is a complex disease that has many possible causes. In America, cancer is now the leading cause of death in young adults and children and the number of new cases of cancer is increasing. People must be aware that early detection, treatment, and recovery can prevent many of the complications of cancer.

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Can cancer be cured?

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There is no known cure for cancer. Treatment can produce some degree of remission, long-term symptom control and stabilization. A small number of patients with metastatic cancer may have a prolonged response to palliative treatment.

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What are common treatments for cancer?

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Chemotherapy therapy, hormonal therapy, radiotherapy, and targeted therapy are common cancer therapies.\n\nThere is still no cure available and treatment is typically aimed at slowing symptoms and improving quality of life.\n\n- Cancers and the environment\n- Medical tourism\n- Cancer and the aging community"

"Neoscleroporthe\n\nNeoscleroporthe is a genus of fungi in the Meliolaceae family; according to the 2007 Outline of Ascomycota, the placement in this family is uncertain.

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What are the latest developments in gsk3901961 for therapeutic use?

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GSK3901961 has shown promise as a new therapeutic agent of osteosarcoma (OP) in a recent phase I study in patients with advanced, previously treated OP. The therapeutic role of GSK390260 in this subset was assessed in phase II clinical trial for OP, in combination with the glucosamine glucosamine sulfate (GSN) and high-dose ascorbic acid (vitamin C) (DAVA). The safety, pharmacology, and tolerability of GSK390260 in OS are being explored. A Phase III GSK390260 study for OS was completed in December 2016. It is expected that results will be available in late 2019 or early 2020.

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What is the primary cause of cancer?

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A multitude of biological factors exist, but no single mechanism. Rather, multiple factors act together in conjunction. The primary factor in cancer is uncontrolled proliferation. Cancer cells are able to replicate in a fast and massive manner, which is caused by increased proliferation pathways. This includes a high metabolism rate and the ability to survive in harsh environments. When the cells divide rapidly, the result is a large tumor.

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Who should consider clinical trials for cancer?

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Clinical trials can help people with cancer to make well-informed medical decisions. Although a medical team can do this part of the trial, patients can benefit from talking freely with an oncologist about treatment options of their disease, regardless of the status of trials.

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What does gsk3901961 usually treat?

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The anti-cancer efficacy of gsk3901961 was demonstrated in preclinical models of breast cancer/leukemia. Results from a recent paper identify a therapeutic strategy for combinatorial cancer therapy that involves the inhibition of the PI3K/AKT/mTOR pathway and warrants clinical evaluation.

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Have there been other clinical trials involving gsk3901961?

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Clinical trials of gsk3901961 for the treatment of adult patients with relapsed or refractory B-cell lymphoma have been terminated. This is because of unacceptably high toxicity in a subset of patients who were treated with the agent. Clinical trials using gsk3901961 in patients with metastatic renal cell carcinoma are ongoing. The safety profile of gsk3901961 in the treatment of these patients remains to be determined.

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Is gsk3901961 typically used in combination with any other treatments?

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Doses of gsk3901961 given within the context of this trial of three weekly doses ranged from 400 mg to 800 mg, in doses of 4 to 16 mg/kg. Subjects who were receiving combination therapy with docetaxel had a dose requirement of 8 mg/kg every two weeks instead of the 6 mg/kg dose required by those receiving the drug as monotherapy.

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