A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

Conditions

• Neuroendocrine Carcinoma
• Small-Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gocatamig — BIOLOGICAL
  IV infusion
• Atezolizumab — BIOLOGICAL
  IV infusion
• Ifinatamab Deruxtecan (I-DXd) — BIOLOGICAL
  IV infusion

Study Details

This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3).

Key Dates

Start date

Dec 14, 2020

Status verified

Feb 2026

Primary completion

Jan 28, 2028

Completion

Jan 28, 2028

Study Design

Enrollment

232 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Gocatamig monotherapy dose escalation with 1 week dosing interval
  Participants will receive gocatamig once weekly (Q1W) via intravenous (IV) infusion during each 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation or the Sponsor decides to stop enrollment.
• Experimental: Gocatamig monotherapy dose escalation with 2 week dosing interval
  Participants will receive gocatamig via IV infusion once every 2 weeks (Q2W) of a 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
• Experimental: Gocatamig monotherapy dose escalation with 3 week dosing interval
  Participants will receive gocatamig via IV infusion once every 3 weeks (Q3W) of a 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
• Experimental: Gocatamig dose escalation with atezolizumab
  Small cell lung cancer (SCLC) participants will receive gocatamig via IV infusion Q2W during each 28-day cycle and Atezolizumab via IV infusion every 4 weeks (Q4W) on Day 1 of each 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
• Experimental: Gocatamig dose escalation in combination with I-DXd
  SCLC participants will receive gocatamig via IV infusion Q2W during each 42-day cycle and I-DXd via IV infusion Q3W on Day 1 and Day 22 of each 42-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.

Primary Outcome Measure

Percentage of participants who experience an adverse event [ Time Frame: Up to ~4 years ]

Locations (11)

Find similar trials in Los Angeles, CA

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