Brief Title: Dose Escalation Study of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin’s Lymphoma

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary Outcome 1 - Timeframe: Up to 30 months

Primary Outcome 2 - Measure: Part 1: Number of Participants Withdrawn Due to AEs

Primary Outcome 2 - Timeframe: Up to 30 months

Primary Outcome 3 - Measure: Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Primary Outcome 3 - Timeframe: Up to 21 days

Primary Outcome 4 - Measure: Part 1: Number of Participants With Dose Modifications of GSK3326595

Primary Outcome 4 - Timeframe: Up to 30 months

Primary Outcome 5 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters

Primary Outcome 5 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 6 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters

Primary Outcome 6 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 7 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters

Primary Outcome 7 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 8 - Measure: Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters

Primary Outcome 8 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 9 - Measure: Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH)

Primary Outcome 9 - Timeframe: Baseline (Day 1) and up to week 132

Primary Outcome 10 - Measure: Part 1: Changes From Baseline in Urine Specific Gravity

Primary Outcome 10 - Timeframe: Baseline (Day 1) and up to week 132

Primary Outcome 11 - Measure: Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs

Primary Outcome 11 - Timeframe: Baseline (Day 1) and up to 30 months

Primary Outcome 12 - Measure: Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary Outcome 12 - Timeframe: Up to 10 months

Primary Outcome 13 - Measure: Part 3: Number of Participants Withdrawn Due to AEs

Primary Outcome 13 - Timeframe: Up to 10 months

Primary Outcome 14 - Measure: Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab

Primary Outcome 14 - Timeframe: Up to 10 months

Primary Outcome 15 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters

Primary Outcome 15 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 16 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters

Primary Outcome 16 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 17 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters

Primary Outcome 17 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 18 - Measure: Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters

Primary Outcome 18 - Timeframe: Baseline (Day 1) and up to 10 months

Primary Outcome 19 - Measure: Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH)

Primary Outcome 19 - Timeframe: Baseline (Day 1) and up to Week 42

Primary Outcome 20 - Measure: Part 3: Changes From Baseline in Urine Specific Gravity

Primary Outcome 20 - Timeframe: Baseline (Day 1) and up to Week 42

Primary Outcome 21 - Measure: Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs

Primary Outcome 21 - Timeframe: Baseline (Day 1) and up to 10 months

CONDITION

• Neoplasms

ELIGIBILITY

Inclusion criteria:
* Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained)

- * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2

- * Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL

- * Presence of evaluable disease

- * Adequate organ function (as defined in the protocol)

- * Reproductive criteria (as defined in the protocol).
Exclusion Criteria:
* Malignancy attributed to prior solid organ transplant

- * Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example [e.g.], for symptomatic disease)

- * History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years

- * Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator

- * Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.

- * Select cardiac abnormalities (as defined in the protocol)

- * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

- * History of optic nerve neuropathy or neuritis.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: GSK Clinical Trials

Role: Study Director

Affiliation: GlaxoSmithKline

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION