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New treatment option for Locally Advanced or Metastatic Malignant Solid Tumors
Official title A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
ClinicalTrials.gov ID: NCT07287995
What this study is testing
What is ASP2998?
ASP2998 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced or metastatic malignant solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For the ASP2998 monotherapy dose escalation (excluding urothelial and non-small cell lung cancer (NSCLC) tumor-specific backfill participants), the...
- Participant has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumors.
- Participant has progressed on, is ineligible for, or has refused all available standard therapies (no limit to the number of prior treatment...
- Prior exposure to TROP2, stimulator of interferon genes (STING) agonist or topoisomerase I (TopI) directed therapy is allowed.
- Participant must have one of the following malignancies: Urothelial carcinoma, NSCLC (nonsquamous cell histology), Gastric/ gastroesophageal junction...
You likely can't join if
- Participant weighs \< 40 kg during screening.
- Participant has known active central nervous system (CNS) metastases. NOTE: A participant with CNS metastases that have been treated with surgery...
- Participant has any of the following:
- Any history of recurrent Grade 3 AEs/ immune-related AEs (irAEs) or history of Grade 4 irAEs related to prior anticancer therapy.
- Recurrent Grade 3 or Grade 4 toxicities related to prior anticancer therapy not improved to Grade ≤ 1 or baseline per National Cancer Institute...
- Participant has active or prior autoimmune or inflammatory disorders requiring systemic anti-inflammatory or immunosuppressive therapy within the...
See the full eligibility criteria
Who can join
- For the ASP2998 monotherapy dose escalation (excluding urothelial and non-small cell lung cancer (NSCLC) tumor-specific backfill participants), the following criteria apply:
- Participant has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumors.
- Participant has progressed on, is ineligible for, or has refused all available standard therapies (no limit to the number of prior treatment regimens).
- Prior exposure to TROP2, stimulator of interferon genes (STING) agonist or topoisomerase I (TopI) directed therapy is allowed.
- Participant must have one of the following malignancies: Urothelial carcinoma, NSCLC (nonsquamous cell histology), Gastric/ gastroesophageal junction (GEJ) cancer, Breast cancer (human epidermal growth factor receptor 2...
- For all tumor types, any component of neuroendocrine histology is ineligible.
- For the ASP2998 NSCLC second line (2L)+ Monotherapy Dose Expansion Cohort(s) (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:
- Participant has locally advanced unresectable or metastatic NSCLC with known programmed cell death-1 (PD-L1) status, without actionable oncogenic alteration (AGA), according to local testing.
- Participant must have histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC that has progressed on or after receiving platinum-based chemotherapy and/or checkpoint...
- Participant is also eligible if there is disease progression within 12 months of receiving neoadjuvant or adjuvant therapy for resectable disease.
- Participant must be eligible to receive treatment in 2L+ setting.
- Participant must have had no more than 3 prior lines of therapy.
- No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.
- For the ASP2998 Urothelial Carcinoma Monotherapy Dose Expansion Cohort(s) (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:
- Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting...
- Participant is also eligible if there is disease progression within 12 months of receiving adjuvant or neoadjuvant therapy for resectable disease.
- Participant must be eligible to receive treatment in 2L+ setting.
- Participant must have had no more than 3 prior lines of therapy.
- No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.
- For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the NSCLC first line (1L) ASP2998 + Pembrolizumab +...
- Participant has locally advanced unresectable or metastatic NSCLC (adenocarcinoma only, no mixed histology allowed), with known PD-L1 status, without AGA, according to local testing.
- Participant is also eligible if there is disease progression \> 12 months after completing adjuvant or neoadjuvant therapy for resectable disease.
- Participant has not received prior therapy for metastatic disease.
- No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed in dose escalation or dose expansion.
- For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the Urothelial Carcinoma 1L ASP2998 + Pembrolizumab +...
- Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting...
- Participant is also eligible if there is disease progression \> 12 months after completing adjuvant or neoadjuvant therapy for resectable disease.
- Participant has not received prior therapy for metastatic disease.
- No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed in dose escalation or dose expansion.
- For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the NSCLC 2L+ ASP2998 + Pembrolizumab Dose Escalation...
- Participant has locally advanced unresectable or metastatic NSCLC with known PD-L1 status, without AGA, according to local testing.
- Participant has progressed on or after receiving platinum-based chemotherapy and/or checkpoint inhibitors according to local/regional standard of care.
- Participant is also eligible if there is disease progression within 12 months of receiving neoadjuvant or adjuvant therapy for resectable disease.
- Participant may be eligible to receive treatment in 2L+ setting.
- Participant must have had no more than 3 prior lines of therapy.
- Prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.
- For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the Urothelial Carcinoma 2L+ ASP2998 + Pembrolizumab...
- Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting...
- Participant is also eligible if there is disease progression within 12 months of receiving adjuvant or neoadjuvant therapy for resectable disease.
- Participant must be eligible to receive treatment in 2L+ setting.
- Participant must have had no more than 3 prior lines of therapy.
- Prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.
- For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the Urothelial Carcinoma 2L+ ASP2998 + Enfortumab...
- Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting...
- Participant is also eligible if there is disease progression within 12 months of receiving adjuvant or neoadjuvant therapy for resectable disease.
- Participant must be eligible to receive treatment in 2L+ setting.
- Participant must have had no more than 3 prior lines of therapy.
- Prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.
- Participant has a predicted life expectancy ≥ 12 weeks.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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...
- Participant's adverse events (AEs) (excluding alopecia) from prior anticancer therapy have improved to Grade 1 or baseline within 14 days prior to the first dose of study intervention.
- Participant has adequate organ function as indicated by laboratory values (If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 14 days after any blood transfusion.)
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who has a negative serum pregnancy test and confirmed not pregnant by medical interview at screening and agrees to follow the contraceptive guidance from the time of informed consent through 7 months after final...
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 7 months after final study intervention administration.
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 7 months after final study intervention administration.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 4 months after final study intervention...
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 4 months after final study intervention...
- Male participant must not donate sperm during the treatment period and for 4 months after final study intervention administration.
- Participant agrees not to participate in another treatment study while receiving study intervention in the present study/participating in the present study (participant who is currently in the follow-up period of an...
What rules you out
- Participant weighs \< 40 kg during screening.
- Participant has known active central nervous system (CNS) metastases. NOTE: A participant with CNS metastases that have been treated with surgery and/or radiation therapy, who is no longer taking pharmacologic doses of...
- Participant has any of the following:
- Any history of recurrent Grade 3 AEs/ immune-related AEs (irAEs) or history of Grade 4 irAEs related to prior anticancer therapy.
- Recurrent Grade 3 or Grade 4 toxicities related to prior anticancer therapy not improved to Grade ≤ 1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 or higher...
- Participant has active or prior autoimmune or inflammatory disorders requiring systemic anti-inflammatory or immunosuppressive therapy within the past 3 years. Participants with type 1 diabetes mellitus or...
- Participant has uncontrolled diabetes mellitus. For cohorts receiving enfortumab vedotin, uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) of ≥ 8% or HbA1c of 7% to \< 8% with associated diabetes symptoms...
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has a known additional malignancy that requires active treatment, with the exception of any of the following:
- Locally curable malignancies that have been apparently cured with no recurrence in the past 2 years.
- Adequately treated stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years.
- Any other cancer from which the participant has been disease-free for ≥ 5 years.
- Participant has a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study...
- Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus (HAV) immunoglobulin M (IgM) positive, but testing for hepatitis A viral load in screening is not...
- Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications. HIV testing will be conducted per local requirements.
- Participant has clinically significant cardiac disease, defined as any of the following:
- Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.
- Congenital long QT syndrome.
- corrected QT interval by Fridericia (QTcF) ≥ 470 msec at screening. Electrocardiograms (ECGs) will be performed in triplicate during screening; the average of the triplicate readings will be used in the calculation of...
- History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction (LVEF) measurement of \< 50% at baseline...
- Uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg that has been confirmed by 2 successive measurements, despite optimal medical management.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study intervention.
- Participant has a history of non-infectious interstitial lung disease (ILD)/pneumonitis, has current Grade ≥ 1 ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. Participant...
- Participant has inadequate pulmonary reserve due to pulmonary, heart or other disease.
- Participant has a confirmed oxygen saturation (SpO2) \< 92% at screening.
- Participant requires chronic oxygen supplementation therapy inclusive of noninvasive ventilation or bilevel positive airway pressure.
- Participant has evidence of structural compromise to the trachea for any reason, including underlying malignancy.
- Participant has had major surgery within 4 weeks prior to first dose of study intervention.
- Participant currently has or has a history of Grade 2 or higher eye disorder, as per NCI-CTCAE v5.0 or higher.
- Participant is at a significant risk of bleeding due to medical condition(s) or use of anticoagulants, or has a history of life-threatening bleeding (e.g., intracranial bleeding).
- Participant has current peripheral neuropathy Grade 2 or higher (specific for enfortumab vedotin or carboplatin-containing cohorts only).
- Participant has a history of Grade 2 or higher hearing loss (specific for the carboplatin-containing cohort only).
- Participant has received prior TROP2 targeting agents, STING agonists or TopI inhibitor (exception: dose escalation cohorts in monotherapy and 2L+ combination therapy).
- Participant has received prior immuno-oncology anticancer therapy within 6 weeks prior to the first dose of study intervention. Participant has received any other prior anticancer therapy within 28 days or 5 half-lives...
- Participant has received prior radiation therapy within 14 days of the first dose of study intervention. Participant must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week...
- Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.
- Participant is expected to require another form of anticancer therapy while on study intervention.
- Participant is receiving anticoagulants (vitamin K antagonists or direct oral anticoagulants) or antiplatelet agents. Low dose aspirin is allowed.
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study intervention.
- Participant has any condition that makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to study intervention or any components of the formulation used.
- Participant has history of life-threatening (anaphylaxis) hypersensitivity reactions to monoclonal antibodies, bispecifics, immunomodulatory drugs or antibody-drug conjugates (ADCs).
- Participant with severe or very severe COPD based on Global Initiative for Obstructive Lung Disease (GOLD) criteria.
- Participant with active hemoptysis within 4 weeks of study enrollment.
- Participant with an airway stent.
- Participant with endobronchial tumor or tumor involvement of the airways.
The study team makes the final eligibility decision.
Where it's taking place
- Hackensack, New Jersey, United States
- New Hyde Park, New York, United States
- Nashville, Tennessee, United States
- Fairfax, Virginia, United States
- Kashiwa-shi, Chiba, Japan
- Chuo-ku, Tokyo, Japan
- Koto-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hackensack, New Jersey, United States; New Hyde Park, New York, United States; Nashville, Tennessee, United States; Fairfax, Virginia, United States; Kashiwa-shi, Chiba, Japan; Chuo-ku, Tokyo, Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.