Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors

Sponsor
Byondis B.V.
Study ID
NCT04235101
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYD985 + Niraparib — DRUG
    SYD985 powder for concentrate for solution for infusion Niraparib 100 mg per hard capsule

Study Details

SYD985.004 is a two-part phase I study with the antibody-drug conjugate SYD985 in combination with niraparib aimed at evaluating safety, pharmacokinetics and efficacy in patients with HER2-expressing locally advanced or metastatic solid tumours.

Key Dates

Start date
Jun 22, 2020
Status verified
Jan 2024
Primary completion
Apr 24, 2023
Completion
Apr 24, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SYD985 + Niraparib
    SYD985, Intravenous, every 3 weeks (Q3W) Niraparib taken orally and either 100 mg, 200 mg or 300 mg once daily for either 1, 2 or 3 weeks.

Primary Outcome Measure

Incidence of dose-limiting toxicities [ Time Frame: 21 days ]

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