Triple Negative Breast CancerPhase 1/2NCT05103917
A Study to Assess the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With TNBC
A Phase 1/2 study testing X4P-001 in people with Triple Negative Breast Cancer, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial 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: 1. To characterize the pharmacokinetics (PK) profile of X4P-001 alone or combined with toriplimab 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- X4P-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2021to 21 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Female, age 18 ~ 75 (including both ends, or other age range required by local regulations or IRB).
- 2. Patients must have histological confirmed locally advanced or metastatic TNBC:
- The primary or metastatic lesions were pathologically confirmed to be triple negative, that is, negative for ER, PR and HER-2. 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.
- 3. ECOG performance status 0~1 4. Life expectancy ≥ 12 weeks 5. 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
Show all 11Show fewer
- Hemoglobin (Hb) ≥90 g/L
- Total bilirubin (TBIL) ≤1.5×ULN
- Aspartate transaminase (AST) and alanine transaminase (ALT), ≤2.5 ×ULN (for the patient with liver metastasis in escalation part or patient in expansion part: AST and AST ≤5×ULN)
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50mL/min based on Cockcroft-Gault formula 6. Female patients of childbearing potential must agree to use effective methods of birth control during the study and for up to 6 months after the last dose of study drug. Non-surgically sterilized female patients of childbearing potential must be in non-lactation period, and have a negative β-HCG test result within 7 days before first administration.
- 7. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
Who cannot join
- 1. 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 2. 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).
- 3. 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. ).
- 4. 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.
- 5. 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.) 6. 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 7. 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).
Show all 14Show fewer
- 8. 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.
- 9. Patients with previous organ transplants 10. Patients with definite active infection or fever of unknown origin > 38.3 ℃ within 4 weeks before receiving the first study drug and were treated with oral or intravenous antibiotics.
- 11. Patients who had previously participated in other clinical studies were included in the original clinical study and less than 28 days after the first administration of the drug in this study.
- 12. Patients whose adverse events caused by previous antineoplastic therapy did not recover to ≤ grade 1 (CTCAE5.0) (except for alopecia, vitiligo, ≤ grade 2 neurotoxicity and other events that researchers believe do not affect the safety evaluation of patients and research drugs).
- 13. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within 6 months before administration of the study drug; b) Clinically significant cardiac arrhythmia requiring active therapy; c) Uncontrolled hypertension; d) Left ventricle ejection fraction<50%; e) Prolongation of QTcF (average of three times of examine, male > 450 ms, female > 470 ms) (Note: QTc interval corrected by Frederica's formula) at screening, and other ECG abnormalities with clinical significant by the judge of the investigator.
- 14. Patients with a history of interstitial pneumonia 15. Patients were positive for (HIV) antibody of human immunodeficiency virus, (HCV) antibody of hepatitis C virus and (TP) antibody of Treponema pallidum, and (HBV) surface antigen of hepatitis B virus was positive and HBVDNA ≥ 1000IU/ml. The subjects are in active stage of tuberculosis; (antiviral therapy is allowed during the trial of subjects with positive (HBV) surface antigen of hepatitis B virus).
- 16. Any other clinically significant comorbidities, such as respiratory, metabolic, congenital, endocrine or central nervous system disease, or any other medical conditions, mental disturbances or social determinants, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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
Read the detailed description
Exploratory Objectives:
- To explore selected biomarkers in peripheral blood and tumor samples that potentially correlate with clinical response to X4P-001 and toriplimab combination treatment
- 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)
- Conditions
- Triple Negative Breast Cancer
- Being tested
- X4P-001
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X4P-001Drug
Also called Toripalimab Injection
CXCR4 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| X4P-001-201 | Experimental | 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) Receives: Drug: X4P-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT
resist 1.1 evaluation
Measured: Screening
CT
resist 1.1 evaluation
Measured: C3D1 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start21 Jul 2021
- Primary completion24 Nov 2022 (estimated)
- Study completion21 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J L Zheng, Director, Study director, Abbisko Therapeutics Co, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103917
- Sponsor's protocol ID
- X4P-001-201
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05103917
- Acronym / sponsor ID
- X4P-001-201
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 24 Nov 2022 (estimated)
- Study completion
- 21 May 2023 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To explore selected biomarkers in peripheral blood and tumor samples that potentially correlate with clinical response to X4P-001 and toriplimab combination treatment
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X4P-001-201 | Experimental | Drug: X4P-001trial 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Female, age 18 ~ 75 (including both ends, or other age range required by local regulations or IRB).
- 3. ECOG performance status 0~1 4. Life expectancy ≥ 12 weeks 5. 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) :
- 7. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
Key exclusion criteria (14 listed)
- 1. 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 2. 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).
- 3. 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. ).
- 4. 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.
- 5. 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.) 6. 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:
- 8. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X4P-001Also: Toripalimab InjectionCXCR4 inhibitor | Drug | X4P-001-201 |
Primary outcome
CT
Time frame: Screening
resist 1.1 evaluation
CT
Time frame: C3D1 (12 weeks)
resist 1.1 evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
Related trials for Triple Negative Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J L Zheng, Director study director
Abbisko Therapeutics Co, Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing X4P-001 in people with Triple Negative Breast Cancer, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT (time frame: Screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.