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Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT07730021

A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors

A Phase 1/2 study testing ASP388B, Pembrolizumab and Carboplatin in people with Locally Advanced or Metastatic Solid Tumors, run by Astellas Pharma Global Development, Inc. at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an early development study of ASP388B in people with solid tumors. In this study, ASP388B will be given to people for the first time. It will be given by itself or together with standard cancer therapies. The main aims of the study are to check the safety of ASP388B and find the most suitable dose. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ASP388B, Pembrolizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
4 sitesin 2 countries
Study dates
2 Sep 2026to 31 May 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For the ASP388B monotherapy dose escalation (excluding the 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 B7-H3, STING agonist or TopI directed therapy is allowed.
  • Participant must have one of the following malignancies (for all tumor types, any compounds of neuroendocrine histology is ineligible): HNSCC, ESCC, mCRPC, sqNSCLC, SCLC
  • For mCRPC
Show all 54Show fewer
  • Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (including but not limited to abiraterone, enzalutamide and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen).
  • Participants must have undergone bilateral orchiectomy or must be on continuous ADT with a GnRH agonist or antagonist.
  • Total serum testosterone ≤ 50 ng/dL or 1.7 nmol/L
  • Evidence of progressive disease, defined as ≥ 1 PCWG3 criteria: PSA level ≥ 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart; Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications; Appearance of ≥ 2 new lesions in bone scan
  • Participants with mCRPC can be enrolled without measurable disease.
  • For sqNSCLC
  • Participants with known EGFR, ALK, ROS, BRAF or other actionable mutations are eligible if treated with mutation targeted therapy and have progressed, relapsed or discontinued treatment due to toxicity.
  • For SCLC
  • Metastatic or extensive stage (EC-SCLC)
  • For the ASP388B 2L+HNSCC monotherapy dose expansion (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:
  • Participant has histologically or cytologically confirmed HNSCC.
  • Tumors arising from the nasopharynx are excluded.
  • Known PD-1/PD-L1 status and any HPV status is eligible.
  • Participant has evidence of radiographic progression on or after the last regimen received.
  • Participant has locally advanced or metastatic disease that is not amenable to curative intent treatment.
  • Participant has progressed, relapsed or discontinued treatment due to toxicity after local guidelines/SOC regimen for locally advanced or metastatic disease, and has received ≤ 3 prior lines of anticancer therapy in the locally advanced or metastatic setting.
  • Neoadjuvant or adjuvant cytotoxic regimens will count as a prior regimen if relapsed or progressed ≤ 6 months after completion.
  • No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
  • For the ASP388B 2L+ESCC monotherapy dose expansion (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:
  • Participant has histologically or cytologically confirmed ESCC.
  • Known PD-1/PD-L1 status and any HER2 status is eligible.
  • Participant has evidence of radiographic progression on or after the last regimen received.
  • Participant has locally advanced or metastatic disease that is not amenable to curative intent treatment.
  • Participant has progressed, relapsed or discontinued treatment due to toxicity after local guidelines/SOC regimen for locally advanced or metastatic disease, and has received ≤ 3 prior lines of anticancer therapy in the locally advanced or metastatic setting.
  • Neoadjuvant or adjuvant cytotoxic regimens will count as a prior regimen if relapsed or progressed ≤ 6 months after completion.
  • No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
  • For the ASP388B 1L HNSCC (Excluding NPC and Salivary Gland Tumors) combination therapy dose escalation and expansion (including the tumor-specific backfill participants from combination therapy dose escalation), the following criteria apply: (ASP388B + Pembrolizumab + Carboplatin + 5-FU):
  • Participant has histologically or cytologically confirmed HNSCC excluding nasopharyngeal cancer (NPC) and salivary gland tumors.
  • Known PD-1/PD-L1 status and any HPV status is eligible
  • Participant has recurrent or metastatic disease that is incurable by local therapies.
  • Participant has had no prior systemic therapy administered with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment with curative intent for nonmetastatic disease stages.
  • No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
  • For the ASP388B 1L ESCC combination therapy dose escalation and expansion (including the tumor-specific backfill participants from combination therapy dose escalation), the following criteria apply: (ASP388B + Pembrolizumab + Oxaliplatin + 5-FU):
  • Participant has histologically or cytologically confirmed ESCC.
  • Known PD-1/PD-L1 status and any HER2 status is eligible
  • Participant has had no prior systemic therapy administered with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment with curative intent for nonmetastatic disease stages.
  • No prior exposure to B7-H3, STING agonist or TopI directed therapy is allowed.
  • For the ASP388B 1L ESCC combination therapy dose escalation and expansion
  • Participant has a predicted life expectancy ≥ 12 weeks.
  • Participant has at least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Participant has an ECOG performance status of 0 or 1.
  • 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 urine or serum pregnancy test at screening with a medical interview and agrees to follow the contraceptive guidance from the time of informed consent through at least 7 months after final study intervention administration or after at least 9 months for participants with 1L ESCC receiving combination therapy, or per local labeling requirements, whichever is longer.
  • Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (approximately 7 months after final study intervention administration or after at least 9 months for participants with 1L ESCC receiving combination therapy, or per local labeling requirements, whichever is longer).
  • 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 administration or after at least 9 months for participants with 1L ESCC receiving combination therapy, or per local labeling requirements, whichever is longer.
  • 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 administration or after at least 9 months for participants with 1L ESCC receiving combination therapy, or per local labeling requirements, whichever is longer.

Who cannot join

  • Participant weighs < 40 kg during screening.
  • Participant has known active central nervous system (CNS) metastases. NOTE: A participant with CNS metastases who has been treated with surgery and/or radiation therapy, who is no longer taking pharmacologic doses of glucocorticoids and is neurologically stable, is eligible. Prophylactic use of anticonvulsants is permitted.
  • Participant has any of the following:
  • Any history of recurrent Grade 3 immune-related AEs (irAEs) or history of Grade 4 irAEs related to prior anticancer therapy.
  • Participant has active or prior autoimmune or inflammatory disorders requiring systemic therapy within the past 2 years including inflammatory skin conditions, inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis or uveitis. The following are exceptions to this criterion:
  • Participant with type 1 diabetes mellitus
Show all 40Show fewer
  • Participant with vitiligo or alopecia
  • Participant with endocrinopathies stably maintained on appropriate replacement therapy
  • Participant with any chronic skin condition that does not require systemic therapy
  • 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:
  • Adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
  • 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 known history of HIV infection with 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 and ventricular arrhythmia, which are poorly controlled; cardiomyopathy or moderate or severe valvular disease. NOTE: Rate-controlled atrial fibrillation is permitted.
  • Congenital long QT syndrome.
  • QTcF ≥ 470 msec at screening. ECGs will be performed in triplicate during screening; the average of the triplicate readings will be used in the calculation of QTcF. If the QTcF is prolonged in a participant with a pacemaker or a right-sided bundle branch block, the participant may be enrolled in the study if confirmed by the sponsor's medical monitor. Participant with a left-sided bundle branch block will be excluded.
  • History of clinically significant cardiac disease or congestive heart failure greater than NYHA Class II or LVEF measurement of < 50% at baseline. Participant must not have had acute coronary syndrome, new-onset angina or coronary revascularization (PCI/CABG) within the past 12 months.
  • Uncontrolled hypertension, defined as systolic BP > 160 mmHg or diastolic BP > 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 the 3 months before start of study intervention.
  • Presence of cardiac injury syndromes: recent cardiac surgery, pacemaker/implantable cardioverter defibrillator insertion, ablation within 3 months prior to screening, recent PCI, blunt or penetrating chest trauma
  • Presence or history of pericarditis (acute, recurrent or restrictive), myocarditis or any pericardial effusion requiring drainage or other invasive procedures
  • History of pericardial tamponade, pericardial involvement associated with connective tissue diseases, sarcoidosis, vasculitis; congenital absence of defect of pericardium; aortic dissection with blood tracking into the pericardial space (hemopericardium/tamponade); iatrogenic hemopericardium (e.g., catheter perforation)
  • Significantly elevated cardiac biomarkers (troponins and NT-proBNP) that require cardiology referral at screening
  • Participant has a history of pleurodesis with impaired lung mechanics, recent (< 6 weeks) pleurodesis or pleural surgery (decortication, pleurectomy), drug-induced fibrosing ILD, trapped lung, complicated pleural effusion, uncontrolled malignant pleural effusion, idiopathic pulmonary fibrosis, pneumonectomy, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, noninfectious ILD/pneumonitis, fibrotic lung disease or connective tissue disorder with pulmonary involvement. Any participant with a history of radiation pneumonitis that required treatment (e.g., steroid) will be excluded, regardless of resolution. NOTE: Participant with previously diagnosed Grade 1 radiation pneumonitis is allowed to be screened for the study. However, radiation pneumonitis must be confined to the previously irradiated area of the lung and be completely resolved.
  • Participant has current Grade ≥ 1 ILD/pneumonitis, evidence of active pneumonitis on screening chest CT scan, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. NOTE: If participant requires intermittent use of bronchodilators, inhaled steroids or local steroid injections, they will not be excluded.
  • Participant has pericardial disease related to prior radiation therapy.
  • Participant has a confirmed SpO2 < 92% at screening.
  • Participant requires chronic oxygen supplementation therapy inclusive of noninvasive ventilation or bilevel positive airway pressure.
  • Participant has any lung or heart disease (e.g., asthma, COPD, congestive heart failure) with uncontrolled symptoms or recent exacerbation or which may confound pulmonary safety assessments.
  • Participant is at a significant risk of bleeding due to medical condition(s) or recent major bleeding (e.g., bleeding in critical site or requiring transfusions).
  • Participant has current peripheral neuropathy Grade ≥ 2 (specific for platinum-containing cohorts only).
  • Participant has a history of Grade ≥ 2 hearing loss (specific for platinum-containing cohorts only).
  • Participant has received any strong inhibitors of CYP3A and CYP1A2 within 1 week or 5 half-lives (whichever is longer) or strong inducers of CYP3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose of ASP388B.
  • Participant has received prior B7-H3 targeting agents, STING agonists or TopI inhibitor (exception: monotherapy dose escalation cohorts).
  • Participant has received prior radiation therapy within 2 weeks of the first dose of study intervention. Participant must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤ 3 weeks of radiotherapy) to non-CNS disease.
  • Participant is receiving anticoagulants (vitamin K antagonists or direct oral anticoagulants) or antiplatelet agents. Low dose aspirin is allowed.
  • 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, whichever is longer, of the first dose of study intervention.

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Astellas Pharma Global Development, Inc. contact

800-888-7704

Astellas.registration@astellas.com

4 sites in 2 countries

United States2 sites, 2 recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • START New York

    Lake Success, New York, 11042

    Recruiting

Other trials in United States

Japan2 sites, 2 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo

    Recruiting

Other trials in Japan

About this study

Official title: A Phase 1b/2 Study of ASP388B as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors

This is an early development study of ASP388B in people with solid tumors. In this study, ASP388B will be given to people for the first time. It will be given by itself or together with standard cancer therapies. The main aims of the study are to check the safety of ASP388B and find the most suitable dose.

This study will be in 2 parts. In Part 1, different small groups of people with solid tumors will receive lower to higher doses of ASP388B. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. Any medical problems will be recorded for each dose. This is to find suitable doses of ASP388B to use in Part 2 of the study, and to include the tumor types that responded well to ASP388B.

Read more

In Part 2, other different small groups of people with the specific tumor types (from Part 1) will receive the most suitable doses worked out from Part 1. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies.

In both parts of the study, ASP388B will be given once in 3-week cycles. The standard cancer therapies will be given according to their approved label. ASP388B and the standard cancer therapies will be given slowly through a tube into a vein. This is called an infusion.

In both parts of the study, health checks will be done at each visit, and the doctors will continue to check for medical problems throughout the study.

Keywords
ASP388B, Safety, Tolerability, Pembrolizumab, Carboplatin, 5-fluorouracil (5-FU), Oxaliplatin, Head and Neck Squamous Cell Carcinoma (HNSCC), Esophageal Squamous Cell Carcinoma (ESCC), Metastatic castration-resistant prostate cancer(mCRPC), Squamous non-small cell lung cancer (sqNSCLC), Small cell lung cancer (SCLC)
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07730021
Study groupRoleWhat they receive
ASP388B Monotherapy Dose EscalationExperimentalParticipants with head and neck squamous cell carcinoma (HNSCC) [including nasopharyngeal cancer (NPC)], esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer(mCRPC), squamous non-small cell lung cancer (sqNSCLC) or small cell lung cancer (SCLC) will receive the dose based on the assigned dose level of ASP388B in 21-day cycles.
Receives: Drug: ASP388B
ASP388B Monotherapy Dose Expansion (HNSCC)ExperimentalParticipants with HNSCC excluding NPC, will receive ASP388B in 21-day cycles with dose level(s) selected from dose escalation.
Receives: Drug: ASP388B
ASP388B Monotherapy Dose Expansion (ESCC)ExperimentalParticipants with ESCC will receive ASP388B in 21-day cycles with dose level(s) selected from dose escalation.
Receives: Drug: ASP388B
ASP388B Combination Therapy Dose Escalation (HNSCC)ExperimentalParticipants with HNSCC excluding NPC and salivary gland tumors will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
Receives: Drug: ASP388B; Drug: Pembrolizumab; Drug: Carboplatin; Drug: 5-fluorouracil
ASP388B Combination Therapy Dose Escalation (ESCC)ExperimentalParticipants with ESCC will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
Receives: Drug: ASP388B; Drug: Pembrolizumab; Drug: Oxaliplatin; Drug: 5-fluorouracil
ASP388B Combination Therapy Dose Expansion (HNSCC)ExperimentalParticipants with HNSCC excluding NPC and salivary gland tumors will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
Receives: Drug: ASP388B; Drug: Pembrolizumab; Drug: Carboplatin; Drug: 5-fluorouracil
ASP388B Combination Therapy Dose Expansion (ESCC)ExperimentalParticipants with ESCC will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
Receives: Drug: ASP388B; Drug: Pembrolizumab; Drug: Oxaliplatin; Drug: 5-fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1) that cannot clearly be attributed to a cause other than ASP388B administered in monotherapy or in combination with standard treatments.

    Measured: Up to 21 days after C1D1

  2. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    NOTE: 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 study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

    A TEAE is an AE with onset at any time from first dosing until last scheduled procedure.

    Measured: Up to 45 months

  3. Number of participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 45 months

  4. Number of participants with vital sign abnormalities and/or AEs

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 45 months

  5. Number of participants with electrocardiogram (ECG) abnormalities and/or AEs

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to 45 months

  6. Number of Participants with Physical Examination (PE) abnormalities and/or AEs

    Number of participants with potentially clinically significant PE values.

    Measured: Up to 45 months

  7. Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score

    The ECOG scale will be used to assess performance status. Scores range from 0 (fully active) to 5 (dead). Negative change scores represent an improvement. Positive scores represent a decline in performance.

    Measured: Up to 45 months

Secondary outcomes (12)

  1. Objective Response Rate (ORR) of ASP388B per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    ORR is defined as the proportion of participants whose best overall response with confirmation is rated as Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator. All tumor types except mCRPC.

    Measured: Up to 45 months

  2. Objective Response Rate (ORR) of ASP388B per Prostate Cancer Working Group 3 (PCWG3)

    ORR is defined as the proportion of participants whose best overall response with confirmation is rated as Complete Response (CR) or Partial Response (PR) per PCWG3 guidance as assessed by the investigator. mCRPC only.

    Measured: Up to 45 months

  3. Duration of Response (DOR) of ASP388B per RECIST v1.1

    DOR is for responders only. DOR is defined as the time from when the measurement criteria is first met for BOR rated as CR or PR (whichever is first recorded) until the first date of documented radiological disease progression by investigator per RECIST v1.1 or death in the absence of progression. All tumor types except mCRPC.

    Measured: Up to 45 months

  4. Duration of Response (DOR) of ASP388B per Prostate Cancer Working Group (PCWG3)

    DOR is for responders only. DOR is defined as the time from when the measurement criteria are first met for BOR rated as CR or PR (whichever is first recorded) until the first date of documented radiological disease progression by investigator per PCWG3 guidance or death in the absence of progression. mCRPC only.

    Measured: Up to 45 months

  5. Disease Control Rate (DCR) of ASP388B per RECIST v1.1

    DCR is defined as the proportion of participants whose best overall response (BOR) with confirmation is rated as CR, PR or stable disease (SD) per RECIST v1.1 as assessed by the investigator. All tumor types except mCRPC.

    Measured: Up to 45 months

  6. Disease Control Rate of ASP388B per Prostrate Cancer Working Group 3 (PCWG3)

    DCR is defined as the proportion of participants whose BOR with confirmation is rated as CR, PR or stable disease (SD) per PCWG3 guidance as assessed by the investigator. mCRPC only.

    Measured: Up to 45 months

  7. Pharmacokinetics (PK) of ASP388B Total Antibody (TAb) in plasma: area under the concentration-time curve at 21 days (AUC21d)

    AUC21d will be recorded from the PK plasma samples collected.

    Measured: Up to 12 months

  8. PK of ASP388B TAb in plasma: maximum concentration (Cmax)

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to 12 months

  9. PK of ASP388B TAb in plasma: trough concentration (Ctrough)

    Ctrough will be recorded from the PK plasma samples collected.

    Measured: Up to 12 months

  10. PK of ASP388B TAb in plasma: time of maximum concentration (tmax)

    tmax will be recorded from the PK plasma samples collected.

    Measured: Up to 12 months

  11. Change from baseline in CD8 T-cell lymphocytes

    CD8 T-cell lymphocytes will be measured from the tumor tissue samples collected.

    Measured: Baseline up to 18 months

  12. Number of Participants with Anti-drug Antibodies (ADA) against ASP388B

    ADA will be recorded from the serum samples collected.

    Measured: Up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start2 Sep 2026
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion31 May 2030 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
392 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07730021
Sponsor's protocol ID
388B-CL-0101
Other IDs
2026-525938-31-00
Status last verified
Oct 2026
First submitted
23 Jul 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASP388B, Pembrolizumab and Carboplatin in people with Locally Advanced or Metastatic Solid Tumors, run by Astellas Pharma Global Development, Inc. at 4 sites in 2 countries.

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 54 inclusion and 40 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Astellas Pharma Global Development, Inc. (800-888-7704, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 21 days after C1D1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07730021.

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 26 Oct 2026.

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