A Study of ASP1570 taken by itself or with pembrolizumab in adults with solid tumors
- Conditions
- ocally advanced or metastatic solid tumors
- Registration Number
- JPRN-jRCT2031220527
- Lead Sponsor
- Sue Lee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 266
1. Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy which is confirmed by available pathology records or current biopsy.
2. Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
3)Monotherapy and Combination Escalation Cohorts:
a) Participant has progressed on standard therapies, is no longer eligible for standard therapies or has refused standard approved therapies
- Monotherapy Expansion Cohorts:
b) Participant has progressed on standard therapies, is no longer eligible for standard therapy or has refused standard approved therapies.
Participant has histologically or cytologically confirmed diagnosis of NSCLC or melanoma (for the respective RP2D Expansion Cohort to which the participant is to be enrolled into), or the tumor type in which confirmed response is observed and a Response-triggered Expansion Cohort is open (for Response-triggered Expansion Cohorts).
c) For participants in the NSCLC monotherapy expansion cohort: participant has no actionable driver mutation (e.g., epidermal growth factor receptor [EGFR], anaplastic lymphomas kinase [ALK], neurotropic receptor tyrosine kinase [NTRK]).
d) For participants in the NSCLC monotherapy expansion cohort: participant has progressed after receiving a checkpoint inhibitor (as monotherapy or in combination with chemotherapy) as the first-line therapy in the advanced setting.
- Monotherapy Dose Optimization Cohorts:
e)Participant has progressed on standard therapies, is no longer eligible for standard therapies or has refused standard approved therapies and has the tumor type selected by the sponsor from the response triggered/RP2D expansion cohorts that meets the criteria for Stage 2 (for Dose Optimization). The initiation of dose optimization will depend upon the observed safety and efficacy.
- Combination Therapy Dose Expansion Cohorts:
f) Participant has histologically or cytologically confirmed diagnosis of NSCLC and
o Stage IV
o programmed cell death protein 1(PD-L1) expression positive (tumor proportion score [TPS] >= 50% measured by 22C3 assay)
o negative for actionable molecular markers
o has not received prior systemic therapy for their locally advanced or metastatic NSCLC
o no contraindications to PD-1 or PD-L1 inhibitors. Contraindications for treatment of PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents which would predict lack of benefit.
4. Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5. (Monotherapy cohorts and combination dose escalation cohorts only): Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days prior to the first dose of Investigational Product (IP) administration. A participant with solid tumors that have NTRK gene fusion without a known acquired resistance mutation or EGFR or ALK mutation-positive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI), ALK inhibitor therapy or NTRK inhibitor therapy until 4 days prior to the first dose of IP.
6. Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to the first dose of IP.
7. Pa
1. Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to the first dose of ASP1570 or 4 weeks prior to the first dose of pembrolizumab.
- Participants may continue the following therapies until 4 days prior to the start of study intervention administration:
a) An EGFR TKI in a participant with EGFR-activating mutations (not applicable to NSCLC monotherapy expansion cohort),
b) ALK inhibitor in a participant with an ALK mutation (not applicable to NSCLC monotherapy expansion cohort) or,
c) NTRK inhibitor in a participant with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation (not applicable to NSCLC monotherapy expansion cohort).
2. Participant requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of IP. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone and up to 10 mg prednisone) are allowed.
3. Participant has received and requires strong or moderate CYP2D6 inhibitors (e.g., bupropion, fluoxetine, paroxetine, duloxetine, abiraterone) during the study.
4. Participant has symptomatic central nervous system (CNS) metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants 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 or > 10 mg per day of prednisone or equivalent) for no longer than 2 weeks.
5. Participant has an active autoimmune disease. Participants with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
6. Participant was discontinued from prior immunomodulatory therapy due to a Grade >= 3 toxicity that was mechanistically related (e.g., immune related) to the agent.
7. Participant has a known history of human immunodeficiency virus (HIV) infection. However, participants with HIV with cluster of differentiation 4 (CD4)+ T-cell counts >= 350 cells/microliters and no history of AIDS-defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for HIV infection should be conducted per local requirements.
8. Participant has any of the following per screening serology test:
o Hepatitis A virus antibodies (immunoglobulin M [IgM])
o Positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B DNA. Participants with negative HBsAg, positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antibody (anti-HBs) are eligible if hepatitis B DNA is undetectable
o Hepatitis C virus (HCV) antibodies unless HCV RNA is undetectable
9. Participant has received a live or live attenuated vaccine against infectious diseases within 28 days prior to the first dose of IP.
10. Participant has a history of pneumonitis (interstitial lung disease), currently has pneumonitis or noninfectious pneumonitis requiring high-dose glucocorticoids.
11. Participant has an infection requiring systemic therapy within 14 days prior to the first dose of IP.
12. Participant has received prior
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method