Health Trials

A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)

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

About this trial

The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227. The study will also see how the levels of Ris-Rez will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, dostarlimab

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants at least 18 years of age (≥18 years)

Participants with advanced/metastatic solid tumors.

For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.

For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting

Disqualifiers

Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.

Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.

Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal/brainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).

Has QT interval, corrected for heart rate (QTc) >450 msec or QTc >480 msec for participants with bundle branch block.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ris-Rez

    Biological/Vaccine

    Ris-Rez will be administered

  • Cisplatin

    Drug

    Cisplatin will be administered

  • Carboplatin

    Drug

    Carboplatin will be administered

  • Atezolizumab

    Biological/Vaccine

    Atezolizumab will be administered

  • Pembrolizumab

    Biological/Vaccine

    Pembrolizumab will be administered

  • Durvalumab

    Biological/Vaccine

    Durvalumab will be administered

  • Cetuximab

    Biological/Vaccine

    Cetuximab will be administered

  • Bevacizumab

    Biological/Vaccine

    Bevacizumab will be administered

  • Tarlatamab

    Biological/Vaccine

    Tarlatamab will be administered

  • Dostarlimab

    Biological/Vaccine

    Dostarlimab will be administered

Treatment groups

845 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Phase 1a- Dose escalation- MonotherapyExperimental treatment 1 intervention
Group B: Phase 1a- Dose escalation- Combination therapyExperimental treatment 10 interventions
Group C: Phase 1b- Dose optimisation- MonotherapyExperimental treatment 1 intervention
Group D: Phase 1b- Dose optimisation- Combination therapyExperimental treatment 3 interventions
Group E: Phase 1b- Dose expansion- MonotherapyExperimental treatment 1 intervention
Group F: Phase 1b- Dose expansion- Combination therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1a: Number of participants with Adverse Events (AEs)

Time frame
Up to approximately 28 months
2

Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs)

Time frame
Up to 21 days
3

Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity

Time frame
Up to approximately 30 months
4

Phase 1a: Number of participants with AEs leading to dose modifications

Time frame
Up to approximately 28 months

Secondary outcomes

1

Phase 1a and Phase 1b: Maximum concentration (Cmax) of Ris-Rez

Time frame
Up to approximately 28 months
2

Phase 1a and Phase 1b: Time to reach maximum concentration (Tmax) of Ris-Rez

Time frame
Up to approximately 28 months
3

Phase 1a and Phase 1b: Area under the curve (AUC) of Ris-Rez

Time frame
Up to approximately 28 months
4

Phase 1a and Phase 1b: Trough concentration (Ctrough) of Ris-Rez (conjugated antibody)

Time frame
Up to approximately 28 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
Apply now