DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

Conditions

• Breast Cancer
• Non-small Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab deruxtecan (DS-8201a) — DRUG
  Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab.
• Trastuzumab deruxtecan (DS-8201a) — DRUG
  Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab. Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin.
• Pembrolizumab — DRUG
  All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.

Study Details

This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

Key Dates

Start date

Feb 10, 2020

Status verified

Nov 2025

Primary completion

Jul 21, 2025

Completion

Mar 31, 2027

Study Design

Enrollment

115 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 (Dose Escalation)
  HER2-positive breast cancer, HER2-low expressing breast cancer, HER2-expressing NSCLC, and HER2-mutant NSCLC participants who received escalating doses of DS8201a (initial dose 3.2 mg/kg Q3W) and pembrolizumab 200 mg.
• Experimental: HER2-positive breast cancer (Part 2 Dose Expansion)
  HER2-positive breast cancer participants with prior ado-trastuzumab emtansine (T-DM1) with disease progression and who received DS8201a at the RDE in combination with pembrolizumab 200 mg.
• Experimental: HER2-low breast cancer (Part 2 Dose Expansion)
  HER2 low breast cancer participants with prior failed standard treatments who received DS8201a at the RDE in combination with pembrolizumab 200 mg.
• Experimental: HER2-expressing NSCLC (Part 2 Dose Expansion)
  HER2-expressing NSCLC participants who had not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents and received DS8201a at the RDE in combination with pembrolizumab 200 mg.
• Experimental: HER2-mutant NSCLC (Part 2 Dose Expansion)
  HER2-mutant NSCLC participants who had not received any prior treatment with anti-PD-1, anti-PD-L1, or HER2 agents and received DS8201a at the RDE in combination with pembrolizumab 200 mg.

Primary Outcome Measure

Dose-limiting toxicities (DLTs), Part 1 [ Time Frame: Within two 3-week cycles (6 weeks) ]

Locations (10)

Find similar trials in San Francisco, CA

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