Locally Advanced (Unresectable) or Metastatic Solid Tumor MalignanciesPhase 1NCT04094506
Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors
A Phase 1 study testing ASP1948 in people with Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The primary purpose of this study is to evaluate the tolerability, safety and pharmacokinetic profile of ASP1948 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors. This study will also evaluate the antitumor effect of ASP1948. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies
- What is being tested?
- ASP1948
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteJapan
- Study dates
- 30 Oct 2019to 2 Feb 2022
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has locally advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy (if needed) and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit for his/her specific tumor type.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days prior to initiation of investigational product (IP) administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive non-small cell lung cancer (NSCLC) is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor therapy until 4 days prior to initiation of IP administration.
- Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to initiation of IP administration.
- Subject with metastatic castration resistant prostate cancer (mCRPC) (positive bone scan and/or soft tissue disease documented by computed tomography [CT]/magnetic resonance imaging [MRI]) meets both of the following:
- Subject has serum testosterone ≤ 50 ng/dL at Screening.
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- Subject has had an orchiectomy or plans to continue androgen deprivation therapy (ADT) for the duration of study treatment.
- Subject has adequate organ function as indicated by laboratory values within 7 days prior to initiation of IP administration. (If a subject has received a recent blood transfusion, the laboratory tests must be obtained ≥ 28 days after any blood transfusion.) Note: Growth factors, colony stimulating factors are not permitted in the screening period.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent throughout the treatment period and for at least 6 months after the final study treatment administration.
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study treatment administration.
- Female subject must not donate ova starting at first dose of IP and throughout the study period, and for 6 months after the final study treatment administration.
- Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for at least 6 months after the final study treatment administration.
- Male subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.
- Male subject with a pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 6 months after the final study treatment administration.
- Subject agrees not to participate in another interventional study while receiving study treatment in the present study (subjects who are currently in the follow-up period of an interventional clinical study are allowed).
Who cannot join
- Subject weighs < 45 kg at Screening.
- Subject has received investigational therapy within 21 days prior to start of IP. (A subject with EGFR activating mutations or a subject with an ALK mutation is allowed to remain on an investigational EGFR TKI or ALK inhibitor until 4 days prior to initiation of IP administration.)
- Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to IP administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone or up to 10 mg per day of rednisone) are allowed. Note: corticosteroids for prophylaxis (e.g., contrast dye allergy) or for brief treatment of conditions not related to study treatment (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is also allowed.
- Subject has symptomatic central nervous system (CNS) metastases or subject has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Subjects with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 28 days prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone, > 2 mg per day of dexamethasone or > 10 mg per day of prednisone or equivalent) for longer than 14 days.
- Subject has leptomeningeal disease as a manifestation of the current malignancy.
- Subject has an active autoimmune disease. Subjects with type 1 diabetes mellitus, stable endocrinopathies maintained on appropriate replacement therapy and skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.
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- Subject was discontinued from prior immunomodulatory therapy due to a Grade ≥ 3 toxicity that was mechanistically related (e.g., immune-related) to the agent.
- Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP1948 or severe hypersensitivity reaction to treatment with another monoclonal antibody.
- Subject is positive for Hepatitis B virus (HBV) antibodies and surface antigen (including acute HBV or chronic HBV) or Hepatitis C virus ([HCV] ribonucleic acid [RNA]). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody testing. HBV antibodies are not required in subjects with negative Hepatitis B surface antigen (HBsAg).
- Subject has received a live vaccine against infectious diseases within 28 days prior to initiation of study treatment.
- Subject has a history of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis.
- Subject has an active infection requiring systemic therapy (e.g., intravenous antibiotics) within 14 days prior to IP treatment.
- Subject is expected to require another form of antineoplastic therapy while on study treatment.
- Subject has an uncontrolled intercurrent illness including, but not limited to cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject's AEs (excluding alopecia) from prior therapy have not improved to Grade 1 or baseline within 14 days prior to start of study treatment.
- Subject has significant cardiovascular disease including:
- Subject has inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
- Subject has a history of myocardial infarction or unstable angina within 6 months prior to Cycle 1 Day 1.
- Subject has New York Heart Association Class II or greater chronic heart failure.
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study treatment.
- Subject has significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study treatment.
- Subject has a history of hemoptysis (bright red blood of 2 mL or more per episode) within 12 weeks prior to study treatment.
- Subject has evidence of a bleeding diathesis or significant coagulopathy.
- Subject has inadequate recovery from prior surgical procedure or has had a major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment, or anticipates the need for a major surgical procedure during the course of the study or minor surgery within 7 days of starting study treatment.
- Subject has initiated new treatment with medications that affect the coagulation cascade with international normalized ratio (INR) ≥ 2 such as vitamin K antagonists, heparins and direct thrombin inhibitors or the use of factor Xa inhibitors within 28 days prior to the start of study treatment. Note: If the subject started receiving such medications more than 28 days prior to the start of study treatment and needs to continue, this is allowed. However, new anticoagulation may not be initiated within 28 days prior to the start of study treatment.
- Subject has any condition that makes the subject unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors
The primary purpose of this study is to evaluate the tolerability, safety and pharmacokinetic profile of ASP1948 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors.
This study will also evaluate the antitumor effect of ASP1948.
Read the detailed description
This study consists of 3 dose levels (1200 milligrams [mg], 2000 mg and 3000 mg) and enrollment of subjects into dose level 1200 mg will take place first. Dose level 2000 mg would only be opened if dose level 1200 mg is deemed tolerable. Dose level 3000 mg would only be opened if dose level 2000 mg is deemed tolerable.
- Being tested
- ASP1948
- Keywords
- safety, ASP1948, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1948Drug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| ASP1948 1200 mg | Experimental | Participants received 1200 mg ASP1948 intravenously, on day 1 of cycle 1 and 2 followed by once every 2 weeks (Q2W) until discontinuation criteria or up to 2 years. Each cycle duration was 14 days. Receives: Drug: ASP1948 |
| ASP1948 2000 mg | Experimental | Participants received 2000 mg ASP1948 intravenously, on day 1 of cycle 1 and 2 followed by once Q2W until discontinuation criteria or up to 2 years. Each cycle duration was 14 days. Receives: Drug: ASP1948 |
| ASP1948 3000 mg | Experimental | Participants received 3000 mg ASP1948 intravenously, on day 1 of cycle 1 followed by once every 3 weeks until discontinuation criteria or up to 2 years. Each cycle duration was 21 days. Receives: Drug: ASP1948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicity (DLT) for Dose level 1200 mg and 2000 mg
DLT is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. The DLT observation period may be increased if deemed appropriate by Dose Escalation and Safety Committee.
Measured: Up to 28 days
Number of participants with DLT for Dose level 3000 mg
DLT is graded using NCI-CTCAE Version 4.03. The DLT observation period may be increased if deemed appropriate by Dose Escalation and Safety Committee.
Measured: Up to 21 days
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject administered an investigational product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with immune-related AEs (irAEs)
Number of participants with potentially clinically significant irAEs. irAEs observed with currently approved checkpoint inhibitors (CPIs) include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis and endocrinopathies (hypophysitis, hypothyroidism, hyperthyroidism, adrenal insufficiency and Type 1 diabetes mellitus).
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with infusion-related reactions (IRRs)
Number of participants with potentially clinically significant IRRs. The majority of IRRs to monoclonal antibodies represent "standard" infusion reactions, and the most common manifestations of these standard infusion reactions include: fever and/or shaking/chills; flushing and/or itching; changes in heart rate and blood pressure; shortness of breath or chest discomfort; pain in back or abdomen; nausea, vomiting and/or diarrhea and skin rash (various types). Fever and muscle pain suggest that the reaction is a standard infusion reaction.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with serious AEs (SAEs)
Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
Number of participants with complete blood count (CBC) value abnormalities and/or AEs
Number of participants with potentially clinically significant CBC values.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with serum chemistry value abnormalities and/or AEs
Number of participants with potentially clinically significant serum chemistry values.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with urinalysis value abnormalities and/or AEs
Number of participants with potentially clinically significant urinalysis values.
Measured: Up to end of treatment period (a maximum of 104 weeks)
Number of participants with prothrombin time/international normalized ratio (PT/INR) value abnormalities and/or AEs
Number of participants with potentially clinically significant PT/INR values.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with activated partial thromboplastin time (aPTT) value abnormalities and/or AEs
Number of participants with potentially clinically significant aPTT values.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with thyroid stimulating hormone (TSH) value abnormalities and/or AEs
Number of participants with potentially clinically significant TSH values.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with free thyroxine (free T4) value abnormalities and/or AEs
Number of participants with potentially clinically significant free T4 values.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Measured: Up to end of treatment period (a maximum of 104 weeks)
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
Number of participants with physical exams abnormalities and/or AEs
Number of participants with potentially clinically significant physical exams values.
Measured: Up to end of treatment period (a maximum of 104 weeks)
Eastern Cooperative Oncology Group (ECOG) performance status score
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 4 (completely disabled). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Measured: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Pharmacokinetics (PK) of ASP1948 in serum: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: AUC from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: Percentage of AUCinf due to extrapolation from the last measurable concentration to time infinity (AUCinf(%extrap))
AUCinf(%extrap) will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: AUC from the time of dosing to the start of next dosing interval (AUCtau)
AUCtau will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: maximum concentration (Cmax)
Cmax will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: dosing time of maximum concentration (tmax)
tmax will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum:dosing: terminal elimination half-life (t1/2)
t1/2 will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: time of last measurable concentration (tlast)
tlast will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: total clearance after intravenous dosing (CL)
CL will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
PK of ASP1948 in serum: volume of distribution after intravenous dosing (V)
V will be recorded from the PK serum samples collected.
Measured: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
Secondary outcomes (2)
Percent change in tumor size from baseline
Tumor size is defined as the sum of the diameters of all target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percent change from baseline in tumor size will be calculated for subjects with target lesions at baseline. The best percent change in tumor size is the maximum percent reduction from baseline, or if the subject has no reduction in size, the minimum percent increase from baseline.
Measured: Up to end of treatment period (a maximum of 104 weeks)
Number of participants with best overall response (BOR)per RECIST 1.1 and 'immune' Response Evaluation Criteria in Solid Tumors (iRECIST)
BOR is defined as the best response recorded from the start of the study treatment until the end of treatment.
Measured: Up to end of treatment period (a maximum of 104 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start30 Oct 2019
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced (Unresectable) or Metastatic Solid Tumor MalignanciesStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094506
- Sponsor's protocol ID
- 1948-CL-0102
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2019
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04094506
- Acronym / sponsor ID
- 1948-CL-0102
- Keywords
- safety, ASP1948, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 19 Sep 2019 (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.
The primary purpose of this study is to evaluate the tolerability, safety and pharmacokinetic profile of ASP1948 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors.
This study will also evaluate the antitumor effect of ASP1948.
Detailed description
This study consists of 3 dose levels (1200 milligrams [mg], 2000 mg and 3000 mg) and enrollment of subjects into dose level 1200 mg will take place first. Dose level 2000 mg would only be opened if dose level 1200 mg is deemed tolerable. Dose level 3000 mg would only be opened if dose level 2000 mg is deemed tolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP1948 1200 mg | Experimental | Drug: ASP1948Participants received 1200 mg ASP1948 intravenously, on day 1 of cycle 1 and 2 followed by once every 2 weeks (Q2W) until discontinuation criteria or up to 2 years. Each cycle duration was 14 days. |
| ASP1948 2000 mg | Experimental | Drug: ASP1948Participants received 2000 mg ASP1948 intravenously, on day 1 of cycle 1 and 2 followed by once Q2W until discontinuation criteria or up to 2 years. Each cycle duration was 14 days. |
| ASP1948 3000 mg | Experimental | Drug: ASP1948Participants received 3000 mg ASP1948 intravenously, on day 1 of cycle 1 followed by once every 3 weeks until discontinuation criteria or up to 2 years. Each cycle duration was 21 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject has locally advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy (if needed) and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit for his/her specific tumor type.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days prior to initiation of investigational product (IP) administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive non-small cell lung cancer (NSCLC) is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor therapy until 4 days prior to initiation of IP administration.
- Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to initiation of IP administration.
- Subject with metastatic castration resistant prostate cancer (mCRPC) (positive bone scan and/or soft tissue disease documented by computed tomography [CT]/magnetic resonance imaging [MRI]) meets both of the following:
Key exclusion criteria (26 listed)
- Subject weighs < 45 kg at Screening.
- Subject has received investigational therapy within 21 days prior to start of IP. (A subject with EGFR activating mutations or a subject with an ALK mutation is allowed to remain on an investigational EGFR TKI or ALK inhibitor until 4 days prior to initiation of IP administration.)
- Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to IP administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone or up to 10 mg per day of rednisone) are allowed. Note: corticosteroids for prophylaxis (e.g., contrast dye allergy) or for brief treatment of conditions not related to study treatment (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is also allowed.
- Subject has symptomatic central nervous system (CNS) metastases or subject has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Subjects with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 28 days prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone, > 2 mg per day of dexamethasone or > 10 mg per day of prednisone or equivalent) for longer than 14 days.
- Subject has leptomeningeal disease as a manifestation of the current malignancy.
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 |
|---|---|---|
| ASP1948Intravenous | Drug | ASP1948 1200 mg, ASP1948 2000 mg, ASP1948 3000 mg |
Primary outcome
Number of participants with Dose Limiting Toxicity (DLT) for Dose level 1200 mg and 2000 mg
Time frame: Up to 28 days
DLT is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. The DLT observation period may be increased if deemed appropriate by Dose Escalation and Safety Committee.
Number of participants with DLT for Dose level 3000 mg
Time frame: Up to 21 days
DLT is graded using NCI-CTCAE Version 4.03. The DLT observation period may be increased if deemed appropriate by Dose Escalation and Safety Committee.
Number of participants with Adverse Events (AEs)
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
An AE is any untoward medical occurrence in a subject administered an investigational product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Number of participants with immune-related AEs (irAEs)
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant irAEs. irAEs observed with currently approved checkpoint inhibitors (CPIs) include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis and endocrinopathies (hypophysitis, hypothyroidism, hyperthyroidism, adrenal insufficiency and Type 1 diabetes mellitus).
Number of participants with infusion-related reactions (IRRs)
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant IRRs. The majority of IRRs to monoclonal antibodies represent "standard" infusion reactions, and the most common manifestations of these standard infusion reactions include: fever and/or shaking/chills; flushing and/or itching; changes in heart rate and blood pressure; shortness of breath or chest discomfort; pain in back or abdomen; nausea, vomiting and/or diarrhea and skin rash (various types). Fever and muscle pain suggest that the reaction is a standard infusion reaction.
Number of participants with serious AEs (SAEs)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Number of participants with complete blood count (CBC) value abnormalities and/or AEs
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant CBC values.
Number of participants with serum chemistry value abnormalities and/or AEs
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant serum chemistry values.
Number of participants with urinalysis value abnormalities and/or AEs
Time frame: Up to end of treatment period (a maximum of 104 weeks)
Number of participants with potentially clinically significant urinalysis values.
Number of participants with prothrombin time/international normalized ratio (PT/INR) value abnormalities and/or AEs
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant PT/INR values.
Number of participants with activated partial thromboplastin time (aPTT) value abnormalities and/or AEs
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant aPTT values.
Number of participants with thyroid stimulating hormone (TSH) value abnormalities and/or AEs
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant TSH values.
Number of participants with free thyroxine (free T4) value abnormalities and/or AEs
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
Number of participants with potentially clinically significant free T4 values.
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to end of treatment period (a maximum of 104 weeks)
Number of participants with potentially clinically significant ECG values.
Number of participants with vital sign abnormalities and/or AEs
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
Number of participants with potentially clinically significant vital sign values.
Number of participants with physical exams abnormalities and/or AEs
Time frame: Up to end of treatment period (a maximum of 104 weeks)
Number of participants with potentially clinically significant physical exams values.
Eastern Cooperative Oncology Group (ECOG) performance status score
Time frame: Up to 30 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 108 weeks)
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 4 (completely disabled). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Pharmacokinetics (PK) of ASP1948 in serum: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
AUClast will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: AUC from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
AUCinf will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: Percentage of AUCinf due to extrapolation from the last measurable concentration to time infinity (AUCinf(%extrap))
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
AUCinf(%extrap) will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: AUC from the time of dosing to the start of next dosing interval (AUCtau)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
AUCtau will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: maximum concentration (Cmax)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
Cmax will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
Ctrough will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: dosing time of maximum concentration (tmax)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
tmax will be recorded from the PK serum samples collected.
PK of ASP1948 in serum:dosing: terminal elimination half-life (t1/2)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
t1/2 will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: time of last measurable concentration (tlast)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
tlast will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: total clearance after intravenous dosing (CL)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
CL will be recorded from the PK serum samples collected.
PK of ASP1948 in serum: volume of distribution after intravenous dosing (V)
Time frame: Up to 90 days after the final IP administration or initiation of a new anticancer treatment, whichever comes first (a maximum of 116 weeks)
V will be recorded from the PK serum samples collected.
2 secondary outcomes
Percent change in tumor size from baseline
Time frame: Up to end of treatment period (a maximum of 104 weeks)
Number of participants with best overall response (BOR)per RECIST 1.1 and 'immune' Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: Up to end of treatment period (a maximum of 104 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Central Contact study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP1948 in people with Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies, run by Astellas Pharma Inc at 1 site in Japan.
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 17 inclusion and 26 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: finished, as of the sponsor's last update on 1 Nov 2024. 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 Japan. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with Dose Limiting Toxicity (DLT) for Dose level 1200 mg and 2000 mg (time frame: Up to 28 days). The study lists 28 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 1 Nov 2024.