An Open Label, Phase Ib/II Trial to Study the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With Toripalimab in Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

Abbisko Therapeutics Co, Ltd1 site in 1 country24 target enrollmentJuly 21, 2021

ConditionsTriple Negative Breast Cancer

InterventionsX4P-001

DrugsX4P-001

Overview

Phase: Phase 1
Intervention: X4P-001
Conditions: Triple Negative Breast Cancer
Sponsor: Abbisko Therapeutics Co, Ltd
Enrollment: 24
Locations: 1
Primary Endpoint: CT
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Objectives Phase 1b

Primary Objectives:

To evaluate the safety and tolerability of X4P-001 combined with toriplimab in patients with locally advanced or metastatic TNBC

Secondary Objectives:

To characterize the pharmacokinetics (PK) profile of X4P-001 alone or combined with toriplimab
To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to RECIST 1.1)
To characterize the overall survival of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC
To characterize the immunogenicity of toriplimab when administrated in combination with X4P-001

Detailed Description

Exploratory Objectives: 1. To explore selected biomarkers in peripheral blood and tumor samples that potentially correlate with clinical response to X4P-001 and toriplimab combination treatment 2. To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to iRECIST 1.1)

Registry

clinicaltrials.gov

Start Date

July 21, 2021

End Date

May 21, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Abbisko Therapeutics Co, Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female, age 18 \~ 75 (including both ends, or other age range required by local regulations or IRB).
•Patients must have histological confirmed locally advanced or metastatic TNBC:
•a) The primary or metastatic lesions were pathologically confirmed to be triple negative, that is, negative for ER, PR and HER-
•Negative ER and PR are defined as ER \< 1% positive and PR \< 1% positive. HER-2 negative is defined as: immunohistochemical detection of HER-2 (-) or (1 +), HER-2 (2 +) must be tested for FISH and the result is negative, HER-2 (1 +) can be selected for FISH test and the result is negative, and metastatic pathology is preferred b) Patient must have at least 1 measurable lesion (by RECIST V1.1) c) Patient must progress after first-line and not more than second-line systematic treatment d) Patient must agree to undergo a tumor biopsy in the study e) Previous tumor tissue samples that meet the requirements should be provided during the screening period, or tumor biopsies should be performed before the first treatment.
•ECOG performance status 0\~1
•Life expectancy ≥ 12 weeks
•Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days before the first dose of study drug (without blood transfusion or medication with stimulation factors within 14 days before 1st dose) :
•Absolute neutrophil count (ANC) ≥1.5×109/L
•Platelet count (PLT) ≥100×109/L
•Hemoglobin (Hb) ≥90 g/L

Exclusion Criteria

•Patients who are known to be allergic to any component of X4P-001 or triplizumab or have previously developed severe allergic reactions, rapid allergic reactions or other hypersensitivity to peptides, chimeric or humanized antibodies, fusion proteins
•Patients who suffer from other malignant tumors within 5 years before enrollment (except: radical cervical carcinoma in situ or non-melanoma skin cancer; second primary cancer that has been cured and has no recurrence within five years; the researchers believe that both primary cancers can benefit from this study; the researchers have clearly confirmed which primary tumor source the metastatic focus belongs to).
•Patients with primary central nervous system malignant tumor; patients with central nervous system metastasis who failed local treatment; (patients with asymptomatic brain metastasis, or patients with stable clinical symptoms and without steroids and other treatment for brain metastasis for more than 28 days can be included in the group. ).
•Patients who use cytochrome P450 (CYP) 3A4, strong 2D6 inhibitors or inducers (see 12.4, including prohibited foods) and antacids before the first use, and the last use is less than 14 days or 5 half-lives from the first use, whichever is the shorter.
•Patient who RANKL ligand inhibitors were used within 1 month before the first administration of the study drug or are expected to be used during the study period (e.g. deschumab, etc.)
•Patients who systemic immunosuppressive drugs (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, etc.) are used within 2 weeks prior to the first administration of research drugs, or systemic immunosuppressive drugs are known to be required in the course of research treatment, unless:
•Patients who receive short-term, low-dose systemic immunosuppressive drugs or patients who receive one-time systemic immunosuppressive drug pulse therapy (such as corticosteroids for 48 hours for the treatment of contrast medium allergic reactions, single use of cyclophosphamide during induction of tumor therapeutic vaccine)
•Patients who receive corticosteroids in the treatment of chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids in the treatment of orthostatic hypotension or adrenal insufficiency are allowed to enter the group
•Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \>30%);routine chemotherapy, targeted therapy, immunotherapy is less than 4 weeks (chemotherapy with nitrosourea or mitomycin \<6 weeks); endocrine therapy within ≤ 5 half-life or ≤ 14 days (whichever is shorter).
•Patients who are unable to take oral drugs or there are factors that significantly affect oral drug absorption, such as gastric remnant dysfunction after previous total gastrectomy or subtotal gastrectomy, short bowel syndrome after small bowel resection, active diarrhea or irritable bowel syndrome requiring drug treatment, etc.

Arms & Interventions

X4P-001-201

trial to Study the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination with Toripalimab in Patients with Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

Intervention: X4P-001