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NeoplasmsPhase 1NCT04446351

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

A Phase 1 study testing GSK6097608, Dostarlimab and Cobolimab in people with Neoplasms, run by GlaxoSmithKline at 11 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
GSK6097608, Dostarlimab and Cobolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
11 sitesin 4 countries
Study dates
25 Jun 2020to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults 18 years of age or older (or >=20 years of age in Arm-A Japan, Arm-D Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan)
  • Female participants of childbearing potential must agree to use a highly effective form of contraception
  • Histological or cytological documentation of locally advanced, recurrent, or metastatic solid malignancy. Enrollment in PK/PD cohorts will be restricted to participants with histologically or cytologically confirmed diagnosis of 1 or more of the following: non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer (EC), colorectal cancer (CRC) (including specified molecular subtypes of these) or an alternative immunogenic tumor type with medical monitor approval
  • Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists
  • Participants in a PK/PD cohort (Arms A, B, E and F) must provide fresh tumor biopsies. Biopsies are not required from participants enrolled in Arm D, Arm E, (non-PK/PD cohorts only), Arm F (non-PK/PD cohort only), Arm G or any participant enrolled in mainland China
  • Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1
Show all 12Show fewer
  • Life expectancy of at least 12 weeks
  • Adequate organ function as determined by laboratory assessments
  • Adequate cardiac ejection fraction as measured by echocardiogram
  • Arm A-Japan, Arm D-Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan only: lives in Japan and is racially Japanese, defined as all biological grandparents being Japanese
  • Arm A-China, Arm B-China, Arm D-China, Arm E-China and Arm F-China only (excluding PK/PD cohorts in Arm E and Arm F): is of Chinese descent and lives in China
  • Arm D, Arm E, Arm F, and Arm G only: has been deemed suitable for assigned treatment based on assessment by the investigator

Who cannot join

  • Prior anti-cancer treatment including investigational agents, immune checkpoint inhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeks or 5 half-lives of the drug, whichever is shorter
  • Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation
  • Toxicity from previous anticancer treatment, including; greater than or equal to (>=) Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or toxicity related to prior treatment that has not resolved; or history of myocarditis of any grade during a previous treatment with immunotherapy
  • Known additional malignancy that progressed or required active treatment within the last 2 years
  • Uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years
Show all 20Show fewer
  • Concurrent medical condition requiring the use of systemic immunosuppressive treatment
  • Cirrhosis or current unstable liver or biliary disease per investigator assessment
  • Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
  • Prolonged QT as measured by electrocardiogram
  • Allergen desensitization therapy within 4 weeks of starting study intervention
  • History of hypersensitivity to any of the study interventions or their excipients
  • Has a history or evidence of cardiac abnormalities within the 6 months prior to enrolment
  • Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions
  • History of idiopathic pulmonary fibrosis; interstitial lung disease; organizing pneumonia; noninfectious pneumonitis that required steroids, or evidence of active, noninfectious pneumonitis
  • Pregnant or lactating woman
  • Receipt of live vaccine within 30 days of the start of study intervention
  • Receipt of transfusion of blood products or administration of colony-stimulating factors within 14 days before the first dose of study intervention
  • Major surgery less than 4 weeks before the first dose of study intervention
  • Known drug or alcohol abuse

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

United States5 sites

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Houston, Texas, 77030-4009

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    San Antonio, Texas, 78229

Other trials in United States

Canada2 sites

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Japan2 sites

  • GSK Investigational Site

    Chiba, 277-8577

  • GSK Investigational Site

    Tokyo, 104-0045

Other trials in Japan

South Korea2 sites

  • GSK Investigational Site

    Seoul, 03080

  • GSK Investigational Site

    Seoul, 06351

Other trials in South Korea

About this study

Official title: A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.

Conditions
Neoplasms
Being tested
GSK6097608, Dostarlimab, Cobolimab, Belrestotug
Keywords
GSK6097608, dostarlimab, Dose escalation, Pharmacokinetics, Pharmacodynamics, Advanced solid tumors, First-time-in-human, GSK4428859A, EOS884448, cobolimab, belrestotug
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK6097608Drug

    GSK6097608 will be administered as an IV infusion.

  • DostarlimabDrug

    Dostarlimab will be administered as an IV infusion.

  • CobolimabDrug

    Cobolimab will be administered as an IV infusion.

  • BelrestotugDrug

    Also called GSK4428859A, EOS884448

    Belrestotug will be administered as an IV infusion.

Study groups in NCT04446351
Study groupRoleWhat they receive
Participants receiving GSK6097608 monotherapy (Arm A)ExperimentalParticipants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.
Receives: Drug: GSK6097608
Participants receiving GSK6097608 plus dostarlimab (Arm B)ExperimentalParticipants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.
Receives: Drug: GSK6097608; Drug: Dostarlimab
Participants receiving dostarlimab monotherapy (Arm D)ExperimentalParticipants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).
Receives: Drug: Dostarlimab
Participants receiving dostarlimab plus belrestotug (Arm E)ExperimentalParticipants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks.
Receives: Drug: Dostarlimab; Drug: Belrestotug
Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)ExperimentalParticipants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks.
Receives: Drug: GSK6097608; Drug: Dostarlimab; Drug: Belrestotug
Participants receiving dostarlimab plus cobolimab (Arm G)ExperimentalParticipants will be administered an IV infusion of cobolimab followed by dostarlimab
Receives: Drug: Dostarlimab; Drug: Cobolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with dose-limiting toxicities (DLTs)

    Measured: Up to Day 21

  2. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Measured: Up to 2 years

Secondary outcomes (41)

  1. Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings

    Measured: Up to 2 years

  2. Number of participants with dose reductions or delay

    Measured: Up to 2 years

  3. Number of participants withdrawn due to AEs

    Measured: Up to 2 years

  4. Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 2 years

  5. Arms D, E, F, G: ORR based on modified Response Evaluation Criteria in Solid Tumors (iRECIST)

    Measured: Up to 2 years

  6. Arms D, E, F, G: Disease Control Rate (DCR) based on RECIST 1.1

    Measured: Up to 2 years

  7. Arms D, E, F, G: DCR based on iRECIST

    Measured: Up to 2 years

  8. Arms D, E, F, G: Time to response (TTR) based on RECIST 1.1

    Measured: Up to 2 years

  9. Arms D, E, F, G: TTR based on iRECIST

    Measured: Up to 2 years

  10. Arms D, E, F, G: Duration of response (DOR) based on RECIST 1.1

    Measured: Up to 2 years

  11. Arms D, E, F, G: DOR based on iRECIST

    Measured: Up to 2 years

  12. Arms D, E, F, G: Progression-free survival (PFS) based on RECIST 1.1

    Measured: Up to 2 years

  13. Arms D, E, F, G: PFS based on iRECIST

    Measured: Up to 2 years

  14. Arms A, B, F: Number of participants with positive anti-drug antibodies (ADAs) against GSK6097608

    Measured: Up to 2 years

  15. Arms A, B, F: Titers of ADAs against GSK6097608

    Measured: Up to 2 years

  16. Arms B, D, E, F, G: Number of participants with positive ADAs against dostarlimab

    Measured: Up to 2 years

  17. Arms B, D, E, F, G: Titers of ADAs against dostarlimab

    Measured: Up to 2 years

  18. Arms E, F: Number of participants with positive ADAs against belrestotug

    Measured: Up to 2 years

  19. Arms E, F: Titers of ADAs against belrestotug

    Measured: Up to 2 years

  20. Arm G: Number of participants with positive ADAs against cobolimab

    Measured: Up to 2 years

  21. Arm G: Titers of ADAs against cobolimab

    Measured: Up to 2 years

  22. Arms A, B, F: Maximum observed concentration (Cmax) for GSK6097608

    Measured: Up to 2 years

  23. Arms A, B, F: Minimum observed concentration (Cmin) for GSK6097608

    Measured: Up to 2 years

  24. Arms A, B, F: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for GSK6097608

    Measured: Up to 2 years

  25. Arms A, B, F: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for GSK6097608

    Measured: Up to 2 years

  26. Arms A, B, F: Apparent terminal phase half-life (t1/2) for GSK6097608

    Measured: Up to 2 years

  27. Arms B, D, E, F, G: Cmax for dostarlimab

    Measured: Up to 2 years

  28. Arms B, D, E, F, G: Cmin for dostarlimab

    Measured: Up to 2 years

  29. Arms B, D, E, F, G: AUC(0-infinity) for dostarlimab

    Measured: Up to 2 years

  30. Arms B, D, E, F, G: AUC(0-t) for dostarlimab

    Measured: Up to 2 years

  31. Arms B, D, E, F, G: t1/2 for dostarlimab

    Measured: Up to 2 years

  32. Arms E, F: Cmax for belrestotug

    Measured: Up to 2 years

  33. Arms E, F: Cmin for belrestotug

    Measured: Up to 2 years

  34. Arms E, F: AUC(0-infinity) for belrestotug

    Measured: Up to 2 years

  35. Arms E, F: AUC(0-t) for belrestotug

    Measured: Up to 2 years

  36. Arms E, F: t1/2 for belrestotug

    Measured: Up to 2 years

  37. Arm G: Cmax for cobolimab

    Measured: Up to 2 years

  38. Arm G: Cmin for cobolimab

    Measured: Up to 2 years

  39. Arm G: AUC(0-infinity) for cobolimab

    Measured: Up to 2 years

  40. Arm G: AUC(0-t) for cobolimab

    Measured: Up to 2 years

  41. Arm G: t1/2 for cobolimab

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2020
  2. Study start25 Jun 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Participants will receive treatment in different dose escalation arms of the study.
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04446351
Sponsor's protocol ID
212214
Status last verified
Oct 2025
First submitted
22 Jun 2020
Last updated
27 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK6097608, Dostarlimab and Cobolimab in people with Neoplasms, run by GlaxoSmithKline at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose-limiting toxicities (DLTs) (time frame: Up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04446351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.

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