Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer

Sponsor
Adlai Nortye Biopharma Co., Ltd.
Study ID
NCT05519059
Phase
PHASE1
Status
Completed

Conditions

  • Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pelareorep — DRUG
    Pelareorep at 1.5×10\^10 TCID50, 3×10\^10 TCID50, 4.5×10\^10 TCID50 on Day 1/2/8/9/15/16 with Paclitaxel at 80 mg/m\^2 on Day 1/8/15 per cycle

Study Details

This ia a multicenter, Single-Arm, Open-Label Phase I Clinical Study Evaluating the Safety and Tolerability of Pelareorep Combined with Paclitaxel Injection and the Intracorporal Process of Pelareorep in Chinese Patients with Advanced or Metastatic Breast Cancer.

Key Dates

Start date
Oct 11, 2021
Status verified
Aug 2022
Primary completion
Sep 29, 2022
Completion
May 30, 2023

Study Design

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

Arms

  • Experimental: Patients With Advanced or Metastatic Breast Cancer
    Patients will receive Pelareorep with Paclitaxel for 8 cycles (28 days/cycle).

Primary Outcome Measure

Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 4 Weeks ]

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