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Advanced Solid MalignanciesPhase 1ICONICNCT07782346

Liposomal Irinotecan Plus Cisplatin in Patients With Advanced or Metastatic Solid Malignancies

A Phase 1 study testing Liposomal Irinotecan Plus Cisplatin in people with Advanced Solid Malignancies, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Phase I trial, Multiple centers, open-label, non-randomized single-arm study Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Advanced Solid Malignancies
What is being tested?
Liposomal Irinotecan Plus Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
6 sitesTaiwan
Study dates
1 Dec 2026to 31 Dec 2032
Phase
Phase 1
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 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients with age 20-85 years old.
  • 2. Cytologically or histologically confirmed solid malignancies which are locally advanced, recurrent or metastatic diseases. The disease cannot be cured by surgical intervention or local therapies.
  • 3. The malignancies are refractory to standard systemic therapy or there is no available systemic therapy.
  • 4. Followings are the diseases entities which are limited in each part:
  • a. Dose escalation phase (cohort 1): non-small cell lung cancer, small cell lung cancer, gastric cancer, neuroendocrine carcinoma, biliary tract cancer (including intrahepatic cholangiocarcinoma [CCA], extrahepatic CCA, gallbladder cancer, ampullary cancer), ovarian cancer, esophageal cancer, thymoma or thymic carcinoma.
  • b. Dose expansion phase (cohort 2): only thymic carcinoma.
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  • 5. Radiologically measurable disease as defined by RECIST v1.1.
  • 6. Baseline ECOG performance status score 0-1.
  • 7. Life expectancy of at least 12 weeks.
  • 8. Adequate hematologic parameters, and hepatic and renal functions defined as
  • a. Absolute neutrophil count ≥ 1500 /μL (without growth factor support at least 7 days).
  • b. Platelets ≥ 90000 /μL (evaluated at least 7 days after last platelet transfusion).
  • c. Hemoglobin ≥ 9 g/dL (evaluated at least 14 days after last RBC transfusion).
  • d. Total bilirubin ≤ 1.5X ULN.
  • e. AST/ALT ≤ 2.5X ULN (≤ 5X ULN if attributable to liver metastases).
  • f. serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 50 mL/min (calculated by Cockcroft-Gault formula [CCr={((140-age) x weight [kg])/(72x serum creatinine [mg/dL])}x 0.85 (if female)] or 24-hour urine collection).
  • 9. Normal ECG or ECG without any clinical significant findings.
  • 10. Able to understand and sign an informed consent (or have a legal representative who is able to do so).
  • 11. Women or men of reproductive potential should agree to use an effective contraceptive method.

Who cannot join

  • 1. Patients who have major surgery, radiotherapy or other systemic chemotherapy or immunotherapy within 3 weeks are not eligible. Patients who have palliative radiotherapy will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
  • 2. Patient with history of severe allergy to liposomal irinotecan (nal-IRI; ONIVYDE®) or cisplatin.
  • 3. Significant cardiovascular impairment: (1) history of congestive heart failure greater than New York Heart Association (NYHA) Class II, left ventricular ejection fraction< 50%; or (2) unstable angina, myocardial infarction or stroke within 6 months; or (3) uncontrolled cardiac arrhythmia.
  • 4. Patients with electrolyte abnormalities that have not been corrected.
  • 5. Patients with active metastatic lesions in central nervous system, or need prednisolone ≥ 10 mg/day to control related symptoms
  • 6. Patients with active bacterial, fungal, tuberculosis or human immunodeficiency virus infection
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  • 7. Patients with positive hepatitis B surface antigen (HBsAg) but not receiving anti-hepatitis B drug. Patients who have positive HBsAg, positive anti-HBc, or positive anti-HCV are eligible if the corresponding HBV-DNA or HCV-RNA are undetectable.
  • 8. Subjects who have not recovered adequately from any toxicity from other anti-cancer treatment regimens and/or complications from major surgery prior to starting therapy.
  • 9. Patients who have peripheral neuropathy > grade I of any etiology.
  • 10. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, or other condition that in the opinion of the investigator would preclude the subject's participation in the study.
  • 11. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma or basal cell carcinoma of skin, or any malignancy which remains disease-free for 3 or more years after curative treatment.
  • 12. Females who are breastfeeding or pregnant at screening or baseline.
  • 13. Patients with psychiatric illness which would preclude study compliance.
  • 13. Patients with psychiatric illness which would preclude study compliance.
  • 14. Patients who have received any prior treatment with ONIVYDE® (liposomal irinotecan) or irinotecan-containing regimens

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Li-Yaun Bai, MD, PhD, contact

886+975-680928

lybai6@gmail.com

Wei-Li Ma, MD, PhD, contact

886-0972653425

excellent0667@gmail.com

6 sites in 1 country

Taiwan6 sites

  • China Medical University Hospital

    Taichung

    Li-Yuan Bai, MD,PhD

  • Taichung Veterans General Hospital

    Taichung

    Huey-En Tzeng, MD,PhD, rollingstone07@gmail.com

  • National Cheng Kung University Hospital

    Tainan

    Chun-Hui Lee, M.D.PhD

  • MacKay Memorial Hospital

    Taipei

    Johnson Lin, MD

  • National Taiwan University Hospital

    Taipei

    Wei-Li Ma, MD

  • Taipei Veterans General Hospital

    Taipei

    Chun-Yu Liu, MD,PhD

Other trials in Taiwan

About this study

Official title: Phase I Trial to Evaluate Safety and Efficacy of Combination of Liposomal Irinotecan (Nal-IRI; ONIVYDE®) and Cisplatin in Patients With Advanced or Metastatic Solid Malignancies (ICONIC Study)

Phase I trial, Multiple centers, open-label, non-randomized single-arm study

Read the detailed description

To assess the safety and anti-tumor activity of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatin in patients with advanced solid malignancies Primary endpoint To find the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatin

Being tested
Liposomal Irinotecan Plus Cisplatin
Keywords
advanced solid malignancies

What participants receive

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

  • Liposomal Irinotecan Plus CisplatinDrug

    Liposomal irinotecan and cisplatin are administered intravenously on Days 1 and 15 of each 28-day cycle.

Study groups in NCT07782346
Study groupRoleWhat they receive
combination of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatinExperimentalPatients receive liposomal irinotecan (nal-IRI) and cisplatin administered intravenously on Days 1 and 15 of each 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Receives: Drug: Liposomal Irinotecan Plus Cisplatin

What is being measured

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

  1. Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

    To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of liposomal irinotecan (nal-IRI) in combination with cisplatin in patients with advanced or metastatic solid malignancies.

    Measured: During cycle one, approximately 28 days

Secondary outcomes (5)

  1. Objective Response Rate (ORR) by RECIST Version 1.1

    Objective response rate (ORR) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Every 8 weeks from first dose until documented disease progression or death from any cause, whichever occurs first.

    Measured: up to approximately 5 years

  2. Progression-Free Survival (PFS)

    Progression-free survival (PFS), defined as the time from the first dose to documented disease progression or death from any cause, whichever occurs first.

    Measured: up to approximately 5 years

  3. Safety Profile

    Safety profile assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE Version 5.0.

    Measured: From initiation of study treatment through 30 days after the end of study treatment.

  4. Overall survival (OS)

    OS will be measured from the start date of study treatment to the date of death.

    Measured: up to approximately 5 years

  5. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1. Tumor assessments will be performed by CT scan within 28 days prior to registration and every 8 weeks after treatment initiation, or as clinically indicated. Objective responses must be confirmed by a subsequent tumor assessment performed at least 4 weeks after the initial response.

    Measured: Every 8 weeks from treatment initiation until documented disease progression, withdrawal, death, or end of study participation, up to approximately 5 years.

Timeline

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

  1. First posted24 Aug 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2032 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study consists of a dose-escalation phase followed by a dose-expansion phase.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07782346
Sponsor's protocol ID
T1Y26
Acronym
ICONIC
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to restrictions related to participant privacy, confidentiality, and informed consent.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Liposomal Irinotecan Plus Cisplatin in people with Advanced Solid Malignancies, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.

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 19 inclusion and 15 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. 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 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.

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 Li-Yaun Bai, MD, PhD, (886+975-680928, lybai6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) (time frame: During cycle one, approximately 28 days). 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 NCT07782346.

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 2 Nov 2026.

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