A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

ConditionNeoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.

Has adequate organ function.

Has histologically confirmed unresectable adenocarcinoma or unresectable metastatic adenocarcinoma of the colon or rectum. (Cohort A)

Histologically or cytologically confirmed adenocarcinoma of the prostate (Cohort B)

Disqualifiers

Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of disease.

Has had any major surgery within 28 days prior to first dose.

Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.

Has serious infection within 4 weeks prior to the first dose,

Trial design

Design model

Sequential

Treatments tested in this trial

  • GSK5764227

    Drug

    Participants will receive GSK5764227.

  • Bevacizumab

    Drug

    Participants will receive bevacizumab.

  • Fluorouracil

    Drug

    Participants will receive fluorouracil.

  • leucovorin

    Drug

    Participants will receive leucovorin.

  • Enzalutamide

    Drug

    Participants will receive enzalutamide.

Treatment groups

83 Participants
are divided into 3 treatment groups
Group A: Metastatic colorectal cancer (mCRC) cohort A1Experimental treatment 2 interventions
Group B: Metastatic colorectal cancer (mCRC) cohort A2Experimental treatment 4 interventions
Group C: Metastatic castration-resistant prostate cancer (mCRPC) cohort BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications

Time frame
Up to approximately 31 weeks
2

Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity

Time frame
Up to approximately 31 weeks
3

Number of participants with dose limiting toxicities (DLTs)

Time frame
Up to approximately 31 weeks
4

Number of participants with clinically significant changes in Vital Signs, Body Weight, Laboratory Tests [Hematology, Clinical Chemistry, Urinalysis], Cardiac Function [ECG], and Eastern Cooperative Oncology Group (ECOG) performance status

Time frame
Up to approximately 31 weeks

Secondary outcomes

1

Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810)

Time frame
Up to approximately 112 weeks
2

Number of participants with anti-drug antibody (ADA) against GSK5764227

Time frame
Up to approximately 112 weeks
3

Number of participants with neutralising antibody (NAb) against GSK5764227

Time frame
Up to approximately 112 weeks
4

Titer of ADA against GSK5764227

Time frame
Up to approximately 112 weeks

Other outcomes

Sponsors and contacts

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