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ASP1570 + Pembrolizumab for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant's adverse events from prior therapy have improved to grade 1 or baseline at least 14 days prior to the first dose of IP
Participant has no actionable driver mutation (e.g., EGFR, ALK, NTRK) for NSCLC monotherapy expansion cohort
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights
Study Summary
This trial is testing a new potential treatment, ASP1570, for people with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors, including NSCLC or melanoma, who have worsened after standard therapy or can't receive it. They must have at least one measurable tumor lesion and be in good physical condition (ECOG 0-1). Participants should not have had recent major surgery, known allergies to the drugs being tested, uncontrolled illnesses, certain infections like HIV/HBV/HCV, or received other treatments that could interfere with the trial.Check my eligibility
What is being tested?
The study tests ASP1570 alone or combined with pembrolizumab on adults with advanced solid tumors. Part 1 determines the best dose of ASP1570; participants take increasing doses unless significant issues arise. In Part 2, they continue with the established best dose from Part 1. Pembrolizumab is given every six weeks for some patients.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to T-cell activation (like inflammation in various organs), infusion reactions from pembrolizumab administration, fatigue, possible digestive disturbances and changes in blood counts which may increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous treatments have mostly gone away.
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My lung cancer does not have mutations like EGFR, ALK, or NTRK.
Select...
My condition worsened after standard treatments, or I can't or won't use them.
Select...
My cancer (NSCLC or melanoma) diagnosis is confirmed by lab tests.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My NSCLC worsened after first-line checkpoint inhibitor therapy.
Select...
My organs are functioning well enough for treatment, based on recent tests.
Select...
My cancer is advanced and cannot be removed by surgery.
Select...
My lung cancer is stage IV, PD-L1 positive, and lacks specific gene changes.
Select...
I am not pregnant and follow the required birth control measures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to 45 days after End of Treatment (EOT) in laboratory values
Incidence of Dose Limiting Toxicities (DLTs) for ASP1570 Single Agent
Number of Participants with Adverse Events (AEs)
+2 moreSecondary outcome measures
Changes in tumor infiltration with CD4/CD8 cells
Disease Control Rate (DCR) of ASP1570 per RECIST 1.1
Disease Control Rate (DCR) of ASP1570 per iRECIST
+9 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
10Treatment groups
Experimental Treatment
Group I: ASP1570 Monotherapy Tumor Specific Dose Expansion - Response-triggered Tumor (Part 2)Experimental Treatment1 Intervention
Participants will receive ASP1570 in a 21-day cycle in tumor-specific cohort if dose escalation cohort had partial response (PR) or complete response (CR) in same tumor type at a dose that has been cleared and deemed tolerable.
Group II: ASP1570 Monotherapy Dose Expansion - Stepwise dosing (Part 2)Experimental Treatment1 Intervention
Participants will receive ASP1570 administered by intra-subject dose escalation with gradual multiple dose steps (e.g., 3 steps) and increased dose up to RP2D in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
Group III: ASP1570 Monotherapy Dose Expansion - Prophylactic Steriods (Part 2)Experimental Treatment1 Intervention
Participants will receive RP2D of ASP1570 along with the prophylactic steroids in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
Group IV: ASP1570 Monotherapy Dose Expansion - Non-Small Cell Lung Carcinoma (NSCLC) (Part 2)Experimental Treatment1 Intervention
Participants who have NSCLC will receive RP2D of ASP1570 daily in a 21-day cycle.
Group V: ASP1570 Monotherapy Dose Expansion - Melanoma (Part 2)Experimental Treatment1 Intervention
Participants who have melanoma will receive recommended Phase 2 dose (RP2D) of ASP1570 in a 21-day cycle.
Group VI: ASP1570 Monotherapy Dose Expansion - Intermittent dosing (Part 2)Experimental Treatment1 Intervention
Participants will receive RP2D of ASP1570 with some periodical drug holiday in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
Group VII: ASP1570 Monotherapy Dose Expansion - Food Effect (Part 2)Experimental Treatment1 Intervention
Participants will receive RP2D of ASP1570 after the meal in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
Group VIII: ASP1570 Monotherapy Dose Escalation (Part 1)Experimental Treatment1 Intervention
Participants will receive daily dose of ASP1570 in a 21-day cycle.
Group IX: ASP1570 + Pembrolizumab Combination therapy Dose Expansion - NSCLC (Part 2)Experimental Treatment2 Interventions
Participants who have NSCLC will receive RP2D of ASP1570 daily in a 21-day cycle. Pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle.
Group X: ASP1570 + Pembrolizumab Combination therapy Dose Escalation (Part 1)Experimental Treatment2 Interventions
Participants will receive daily dose of ASP1570 in a 21-day cycle. Pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,341 Total Patients Enrolled
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,756 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,410 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of unusual bleeding.I am allergic to ASP1570 or pembrolizumab.My side effects from previous treatments have mostly gone away.My lung cancer does not have mutations like EGFR, ALK, or NTRK.I have taken steroids or other immune-weakening medicines in the last 14 days.I had radiotherapy less than 2 weeks ago or have had radiation pneumonitis.I have not taken medication for an infection in the last 14 days.I had major surgery less than 4 weeks before starting the treatment.I've had lung radiation therapy of more than 30 Gy in the last 6 months.I have had a stem cell or organ transplant.I will need additional cancer treatment while on this study.I have symptoms from cancer spread to my brain or it's unstable.My condition worsened after standard treatments, or I can't or won't use them.I need to take strong or moderate drugs that affect liver enzyme CYP2D6 during the study.I have had or currently have pneumonitis that needed strong steroids.My cancer (NSCLC or melanoma) diagnosis is confirmed by lab tests.I agree to use contraception with my partner who can become pregnant.I haven't taken any experimental drugs within the last 21 days or before the half-life period prior to starting ASP1570 or pembrolizumab.I am fully active or restricted in physically strenuous activity but can do light work.My NSCLC worsened after first-line checkpoint inhibitor therapy.My cancer has not responded to standard treatments, or I am not eligible for or have refused them.My organs are functioning well enough for treatment, based on recent tests.I am HIV-positive and have had Kaposi sarcoma or Multicentric Castleman Disease.I have not had any cancer except for certain types in the last 2 years.I finished my radiotherapy at least 2 weeks ago.I stopped my previous immune therapy due to severe side effects.My cancer is advanced and cannot be removed by surgery.I need blood-thinning medication.My lung cancer is stage IV, PD-L1 positive, and lacks specific gene changes.I am not pregnant and follow the required birth control measures.My last cancer treatment was over 3 weeks ago.I had a heart attack or unstable chest pain within the last 6 months.I have at least one tumor that can be measured according to RECIST v1.1.My high blood pressure is not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: ASP1570 Monotherapy Dose Escalation (Part 1)
- Group 2: ASP1570 Monotherapy Dose Expansion - Melanoma (Part 2)
- Group 3: ASP1570 Monotherapy Tumor Specific Dose Expansion - Response-triggered Tumor (Part 2)
- Group 4: ASP1570 Monotherapy Dose Expansion - Non-Small Cell Lung Carcinoma (NSCLC) (Part 2)
- Group 5: ASP1570 Monotherapy Dose Expansion - Stepwise dosing (Part 2)
- Group 6: ASP1570 + Pembrolizumab Combination therapy Dose Escalation (Part 1)
- Group 7: ASP1570 Monotherapy Dose Expansion - Prophylactic Steriods (Part 2)
- Group 8: ASP1570 + Pembrolizumab Combination therapy Dose Expansion - NSCLC (Part 2)
- Group 9: ASP1570 Monotherapy Dose Expansion - Food Effect (Part 2)
- Group 10: ASP1570 Monotherapy Dose Expansion - Intermittent dosing (Part 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many centers are actively overseeing this research?
"Currently, 11 trial sites are operational. These centres are situated in Nashville, Chicago and Lexington with the other 8 being dispersed around the USA. Potential participants should select a clinic closest to them for their own convenience."
Answered by AI
What purpose is this medical experiment attempting to fulfill?
"The principal purpose of this research, to be examined over a period extending up to 27 months, is gauging the number of patients exhibiting vital sign deficiencies and/or adverse events. Supplementary outcomes include measuring pharmacokinetic concentrations in plasma (AUCtau), variations in tumor infiltration with CD4/CD8 cells, and Drug Control Rate (DCR) per Response Evaluation Criteria In Solid Tumors 1.1."
Answered by AI
What is the cap on enrollment for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting and was initially posted on October 19th 2021. The most recent update was made on November 18 2022 and the trial is looking for 168 participants across 11 different sites."
Answered by AI
Is this clinical research currently enrolling participants?
"According to the records on clinicaltrials.gov, this trial is currently enrolling patients with an initial posting date of October 19th 2021 and a recent update made in November 18th 2022."
Answered by AI
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