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A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)

ConditionsSmall Cell Lung Cancer (SCLC)Large Cell Neuroendocrine Cancer (LCNEC)Neuroendocrine Prostate Cancer (NEPC)Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)Neuroendocrine Carcinomas (NEC)Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhanes Therapeutics

About this trial

This is a first-in-human, Phase 1/2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig (PT217) as a monotherapy and in combination with chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older and able to sign informed consent and comply with the protocol.

Measurable disease as defined by RECIST v1.1 criteria for solid tumors.

NECs that have transformed from NSCLC are not eligible.

Substudy C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment. SCLC patients who have relapsed on a 1L treatment (including platinum-based therapy with or without ICI) but remain platinum sensitive (defined as patients who experienced disease progression at least 90 days after their last platinum based chemotherapy) and are eligible for CE treatment rechallenge.

Disqualifiers

Women who are pregnant or lactating.

Women of child-bearing potential (WOCBP) who do not use adequate birth control.

Autoimmune disease requiring systemic treatment within the past twelve months.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Peluntamig (PT217)

    Drug

    A bispecific antibody (bsAb) against DLL3 and CD47.

  • Carboplatin + Etoposide

    Drug

    Administered per Standard of Care.

  • Paclitaxel.

    Drug

    Administered per Standard of Care.

  • Atezolizumab

    Drug

    Administered per Standard of Care.

  • Lurbinectedin

    Drug

    Administered per Standard of Care.

  • Irinotecan (drug)

    Drug

    Administered per Standard of Care.

  • Topotecan

    Drug

    Administered per Standard of Care.

Treatment groups

203 Participants
are divided into 4 treatment groups
Group A: Part A: Dose EscalationExperimental treatment 1 intervention
Group B: Part B: Dose ExpansionExperimental treatment 1 intervention
Group C: Part C: Chemotherapy Combination TherapyExperimental treatment 6 interventions
Group D: Part D: ICI Combination TherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

To determine recommended dose for expansion (RDE) of Peluntamig (PT217).

Time frame
Through study completion, up to approximately 3 years.
2

To evaluate the safety and tolerability of Peluntamig (PT217).

Time frame
Through study completion, up to approximately 3 years.
3

To evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments as assessed by ORR.

Time frame
Through study completion, up to approximately 3 years.

Secondary outcomes

1

To evaluate the pharmacokinetics of Peluntamig (PT217).

Time frame
Through study completion, up to approximately 3 years.
2

To evaluate the immunogenicity (ADA) of Peluntamig (PT217).

Time frame
Through study completion, up to approximately 3 years.
3

To further evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments

Time frame
Through study completion, up to approximately 3 years.

Other outcomes

Sponsors and contacts

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

Phanes Therapeutics

Lead sponsor

Hoffmann-La Roche

Collaborator

Source ClinicalTrials.gov
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