Clinical Trials List
Protocol Number1951-CL-0101
2020-09-01 - 2023-09-20
Phase I
Recruiting3
A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
-
Trial Applicant
ICON Clinical Research Pte Ltd
-
Sponsor
Astellas Pharma Global Development Inc. (APGD)
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Yu-Fang Huang 未分科
- Wen-Pin Su 未分科
- Shang-Yin Wu 未分科
- Yu-Min Yeh 未分科
- Po-Lan Su 未分科
- Chun-Hui Lee 未分科
- Jui-Hung Tsai 未分科
- Chien-Chung Lin 未分科
- Chia-Jui Yen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳盛裕 未分科
- Tien-Hua Chen 未分科
- Muh-Hwa Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ching Yun Hsieh Division of Hematology & Oncology
- Te-Chun Hsia Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Chih-Yen Tu Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
- Li-Yuan Bai Division of Hematology & Oncology
- Tao-Wei Ke Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
4 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
Primary Objectives:
To evaluate the tolerability and safety profile of ASP1951 when administered as a single agent
and in combination with pembrolizumab in subjects with locally advanced (unresectable) or
metastatic solid tumors
To characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and
in combination with pembrolizumab
To determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated
dose (MTD) when administered as a single agent and in combination with pembrolizumab
Test Drug
ASP1951
Active Ingredient
ASP1951
Dosage Form
靜脈輸注（IV）
Dosage
25 mg/mL (250 mg/10 mL)
Endpoints
Variable that pertains to the efficacy or safety evaluations of a study.
Note: Not all endpoints are themselves assessments since certain endpoints
might apply to populations or emerge from analysis of results. That is,
endpoints might be facts about assessments (e.g., prolongation of survival).
Note: Not all endpoints are themselves assessments since certain endpoints
might apply to populations or emerge from analysis of results. That is,
endpoints might be facts about assessments (e.g., prolongation of survival).
Inclution Criteria
1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written
informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for
US sites) must be obtained from the subject prior to any study-related procedures (including
withdrawal of prohibited medication, if applicable).
2. The subject is at least 18 years of age and legally an adult according to local regulation at the time
of signing the informed consent form (ICF).
3. 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 as well as the following:
a) Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit in the opinion of the treating investigator for his/her specific tumor type.
OR
b) Subject in an expansion cohort has received at least 1 standard therapy for his/her specific tumor type.
4. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
5. Subject’s last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or
5 half-lives, whichever is shorter, prior to initiation of study drug administration. A subject with
epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutationpositive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor
therapy until 4 days prior to the start of study drug administration.
6. Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks
prior to study drug administration.
7. Subject’s AEs (excluding alopecia) from prior therapy have improved to grade 1
or baseline within 2 weeks prior to start of study treatment.
8. 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.
Subject has had a bilateral orchiectomy or plans to continue androgen deprivation therapy
(ADT) for the duration of study treatment.
9. Subject has adequate organ function prior to start of study treatment as indicated by the following
laboratory values. If a subject has received a recent blood transfusion, the laboratory tests must be
obtained ≥ 4 weeks after any blood transfusion.
10. A female subject is eligible to participate if she is not pregnant [see Appendix 12.3 Contraception
Requirements] and at least 1 of the following conditions applies:
a) Not a woman of childbearing potential (WOCBP) as defined in [Appendix 12.3
Contraception Requirements]
OR
b) WOCBP who agrees to follow the contraceptive guidance as defined in [Appendix 12.3
Contraception Requirements] throughout the treatment period and for at least 6 months after
the final study drug administration.
11. Female subject must agree not to breastfeed starting at Screening and throughout the study
treatment, and for 6 months after the final study drug administration.
12. Female subject must not donate ova starting at Screening and throughout the study treatment, and
for 6 months after the final study drug administration.
13. A male subject with female partner(s) of childbearing potential must agree to use contraception as
detailed in [Appendix 12.3 Contraception Requirements] during the treatment period and for at
least 6 months after the final study drug administration.
14. A male subject must not donate sperm during the treatment period and for at least 6 months after
the final study drug administration.
15. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a
condom for the duration of the pregnancy or time partner is breastfeeding throughout the study
period and for 6 months after the final study drug administration.
16. Subject agrees not to participate in another interventional study while receiving study drug
(Subjects who are currently in the Follow-up Period of an interventional clinical trial are
allowed).
informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for
US sites) must be obtained from the subject prior to any study-related procedures (including
withdrawal of prohibited medication, if applicable).
2. The subject is at least 18 years of age and legally an adult according to local regulation at the time
of signing the informed consent form (ICF).
3. 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 as well as the following:
a) Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit in the opinion of the treating investigator for his/her specific tumor type.
OR
b) Subject in an expansion cohort has received at least 1 standard therapy for his/her specific tumor type.
4. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
5. Subject’s last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or
5 half-lives, whichever is shorter, prior to initiation of study drug administration. A subject with
epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutationpositive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor
therapy until 4 days prior to the start of study drug administration.
6. Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks
prior to study drug administration.
7. Subject’s AEs (excluding alopecia) from prior therapy have improved to grade 1
or baseline within 2 weeks prior to start of study treatment.
8. 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.
Subject has had a bilateral orchiectomy or plans to continue androgen deprivation therapy
(ADT) for the duration of study treatment.
9. Subject has adequate organ function prior to start of study treatment as indicated by the following
laboratory values. If a subject has received a recent blood transfusion, the laboratory tests must be
obtained ≥ 4 weeks after any blood transfusion.
10. A female subject is eligible to participate if she is not pregnant [see Appendix 12.3 Contraception
Requirements] and at least 1 of the following conditions applies:
a) Not a woman of childbearing potential (WOCBP) as defined in [Appendix 12.3
Contraception Requirements]
OR
b) WOCBP who agrees to follow the contraceptive guidance as defined in [Appendix 12.3
Contraception Requirements] throughout the treatment period and for at least 6 months after
the final study drug administration.
11. Female subject must agree not to breastfeed starting at Screening and throughout the study
treatment, and for 6 months after the final study drug administration.
12. Female subject must not donate ova starting at Screening and throughout the study treatment, and
for 6 months after the final study drug administration.
13. A male subject with female partner(s) of childbearing potential must agree to use contraception as
detailed in [Appendix 12.3 Contraception Requirements] during the treatment period and for at
least 6 months after the final study drug administration.
14. A male subject must not donate sperm during the treatment period and for at least 6 months after
the final study drug administration.
15. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a
condom for the duration of the pregnancy or time partner is breastfeeding throughout the study
period and for 6 months after the final study drug administration.
16. Subject agrees not to participate in another interventional study while receiving study drug
(Subjects who are currently in the Follow-up Period of an interventional clinical trial are
allowed).
Exclusion Criteria
1. Subject weighs < 45 kg.
2. Subject has received investigational therapy (other than an investigational EGFR TKI in a subject
with EGFR activating mutations or ALK inhibitor in a subject with an ALK mutation) within
21 days or 5 half-lives, whichever is shorter, prior to start of study drug.
3. Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy
within 14 days prior to study drug 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 prednisone) are allowed.
4. 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 4 weeks 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
2 weeks.
5. Subject has leptomeningeal disease as a manifestation of the current malignancy.
6. Subject has an active autoimmune disease that has required systemic treatment in the past 2 years.
Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate
replacement therapy, and skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring
systemic treatment are allowed.
7. Subject was discontinued from prior immunomodulatory therapy due to a grade ≥ 3 toxicity
that was mechanistically related (e.g., immune related) to the agent in the judgment of the
investigator.
8. Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP1951
or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal
antibody.
9. Subject with positive Hepatitis B virus (HBV) antibodies and surface antigen (indicating acute
HBV or chronic HBV) or Hepatitis C ([HCV]; ribonucleic acid [RNA] detected by qualitative
assay). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody
testing. HBV antibodies are not required in subjects with negative HBV surface antigen.
10. Subject has received a live vaccine against infectious diseases within 4 weeks prior to initiation of
study treatment.
11. Subject has a history of drug-induced pneumonitis (interstitial lung disease), a history of
(non-infectious) pneumonitis that required steroids, radiation pneumonitis or currently has
pneumonitis.
12. Subject has an infection requiring systemic therapy within 2 weeks prior to study drug
administration.
13. Subject has received a prior allogeneic bone marrow or solid organ transplant.
14. Subject is expected to require another form of antineoplastic therapy while on study treatment.
15. Subject has had a myocardial infarction or unstable angina within 6 months prior to the start of
study treatment or currently has an uncontrolled illness including, but not limited to symptomatic
congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with study
requirements.
16. Subject has received prior treatment with an anti-GITR antibody.
17. Subject has had a major surgical procedure and has not completely recovered within 28 days prior
to the start of study treatment.
18. Subject has any condition, which in the investigator’s opinion, makes the subject unsuitable for
study participation.
2. Subject has received investigational therapy (other than an investigational EGFR TKI in a subject
with EGFR activating mutations or ALK inhibitor in a subject with an ALK mutation) within
21 days or 5 half-lives, whichever is shorter, prior to start of study drug.
3. Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy
within 14 days prior to study drug 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 prednisone) are allowed.
4. 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 4 weeks 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
2 weeks.
5. Subject has leptomeningeal disease as a manifestation of the current malignancy.
6. Subject has an active autoimmune disease that has required systemic treatment in the past 2 years.
Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate
replacement therapy, and skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring
systemic treatment are allowed.
7. Subject was discontinued from prior immunomodulatory therapy due to a grade ≥ 3 toxicity
that was mechanistically related (e.g., immune related) to the agent in the judgment of the
investigator.
8. Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP1951
or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal
antibody.
9. Subject with positive Hepatitis B virus (HBV) antibodies and surface antigen (indicating acute
HBV or chronic HBV) or Hepatitis C ([HCV]; ribonucleic acid [RNA] detected by qualitative
assay). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody
testing. HBV antibodies are not required in subjects with negative HBV surface antigen.
10. Subject has received a live vaccine against infectious diseases within 4 weeks prior to initiation of
study treatment.
11. Subject has a history of drug-induced pneumonitis (interstitial lung disease), a history of
(non-infectious) pneumonitis that required steroids, radiation pneumonitis or currently has
pneumonitis.
12. Subject has an infection requiring systemic therapy within 2 weeks prior to study drug
administration.
13. Subject has received a prior allogeneic bone marrow or solid organ transplant.
14. Subject is expected to require another form of antineoplastic therapy while on study treatment.
15. Subject has had a myocardial infarction or unstable angina within 6 months prior to the start of
study treatment or currently has an uncontrolled illness including, but not limited to symptomatic
congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with study
requirements.
16. Subject has received prior treatment with an anti-GITR antibody.
17. Subject has had a major surgical procedure and has not completely recovered within 28 days prior
to the start of study treatment.
18. Subject has any condition, which in the investigator’s opinion, makes the subject unsuitable for
study participation.
The Estimated Number of Participants
-
Taiwan
10 participants
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Global
435 participants
