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Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer

ConditionsAdvanced Urothelial CancerMetastatic Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenerate Biomedicines

About this trial

The purpose of this study is to evaluate the safety and tolerability of an investigational drug called GB-4362 when it is given together with enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. GB-4362 is a monoclonal antibody designed to bind and neutralize free monomethyl auristatin E (MMAE), a chemotherapy payload released from enfortumab vedotin that is associated with side effects such as peripheral neuropathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Planned to receive standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg/kg) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer.

Age ≥18 years.

ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion).

Weight ≥50 kg at screening.

Disqualifiers

Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).

Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV/pembrolizumab.

Uncontrolled diabetes.

CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GB-4362

    Drug

    GB-4362 is an investigational monoclonal antibody

  • enfortumab vedotin (EV)

    Drug

    Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4 that delivers the cytotoxic payload monomethyl auristatin E (MMAE).

  • Pembrolizumab

    Drug

    Pembrolizumab is a programmed death-1 (PD-1) immune checkpoint inhibitor administered as standard-of-care therapy for advanced urothelial cancer.

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: GB-4362 in Combination With Enfortumab Vedotin and PembrolizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of AEs and SAEs

Time frame
From first dose of GB-4362 through 18 weeks after the last dose of GB-4362 (or prior to initiation of subsequent anti-cancer therapy, whichever occurs first).

Secondary outcomes

1

Pharmacokinetics of GB-4362

Maximum plasma concentration (Cmax) of GB-4362 following administration with enfortumab vedotin and pembrolizumab.

Time frame
From first dose of GB-4362 through 18 weeks after the last dose of GB-4362 (or prior to initiation of subsequent anti-cancer therapy, whichever occurs first).
2

Reduction of Free MMAE Levels

Time frame
From first dose of GB-4362 through 18 weeks after the last dose of GB-4362 (or prior to initiation of subsequent anti-cancer therapy, whichever occurs first).
3

Immunogenicity of GB-4362

Incidence of treatment emergent anti-drug antibody against GB-4362

Time frame
From first dose of GB-4362 through 18 weeks after the last dose of GB-4362 (or prior to initiation of subsequent anti-cancer therapy, whichever occurs first).

Other outcomes

Sponsors and contacts

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Generate Biomedicines

Lead sponsor

Source ClinicalTrials.gov
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