A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer

Conditions

• HER2-negative Metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DAN-222 — DRUG
  Administered IV every week to subjects
• Niraparib — DRUG
  Administered orally once daily

Study Details

This was an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib: * Part A is dose escalation of single agent DAN-222 * Part B is dose escalation of DAN-222 in combination with niraparib

Key Dates

Start date

Feb 2, 2022

Status verified

Dec 2023

Primary completion

Sep 13, 2023

Completion

Oct 11, 2023

Study Design

Enrollment

30 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation (DAN-222)
  The starting dose of DAN-222 will be administered IV every week (QW) to subjects in the first cohort.
• Experimental: Dose Escalation (DAN-222 + niraparib)
  The starting dose of DAN-222 will be administered IV every week (QW), in combination with daily oral niraparib.

Primary Outcome Measure

Incidence and nature of Dose Limiting Toxicities (DLTs) [ Time Frame: 3 years ]

Locations (9)

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