Ovarian Cancer RecurrentPhase 2NCT06014528
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
A Phase 2 study testing IN10018 and Pegylated Liposomal Doxorubicin in people with Ovarian Cancer Recurrent, run by InxMed (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- IN10018 and Pegylated Liposomal Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2022to 24 Dec 2026
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures, except those procedures used as institutional standard of care falling into the protocol specified window and fulfilling study specific requirements such as tumor imaging.
- Female subjects ≥ 18 years at the time of signing informed consent.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma (HGSC).
- Have received platinum containing therapy and have radiological relapse or progression during platinum containing treatment or < 6 months (184 calendar days) after completion of prior platinum-based therapy (at least 4 cycles).
- Note: Disease progression or recurrence requires evidence of radiographic or clinical progression (e.g., new ascites or cytological reports of pleural fluid), and elevated CA125 alone is not a criterion for progression or recurrence. Primary platinum-refractory ovarian cancers (defined as progression during or within 4 weeks after first line platinum-based therapy) is excluded, while secondary platinum-refractory disease is allowed and does not require at least 4 cycles of platinum-based therapy.
- Maximum total of 3 prior lines of systemic therapy are allowed. Note: Hormonal therapies (e.g., tamoxifen), PARP inhibitors and bevacizumab given in the maintenance setting post response to platinum-based therapy will not count as a treatment line. Other maintenance regimens may also not count as a treatment line by discussion between the investigator and sponsor.
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- At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator.
- Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months as assessed by investigator.
- Availability of archival or fresh (newly obtained) tumor tissue sample during screening phase: fresh tumor tissue sample obtained after most recent relapse or progression is preferred; if no sample or not sufficient number of slides (refer to Laboratory Manual which will be provided separately) can be provided or collected, a joint decision between sponsor and investigator is needed for the enrollment of this subject.
- Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.
- Note: subjects with minor toxicities with no safety concern like alopecia and Grade 2 neuropathy could be enrolled per evaluation of investigator.
- Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to randomization.
- Hemoglobin (Hb) ≥ 100 g/L (10 g/dL), independent of blood infusion, red blood cell transfusion and erythropoietin (EPO) use within 14 days prior to the screening period examination.
- Platelet count ≥ 100 × 109/L, independent of platelet infusion within 14 days prior to the screening period examination.
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, independent of colony stimulating factor (CSF) use within 14 days prior to the screening period examination.
- Total bilirubin ≤ upper limit of normal (ULN).
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for subjects with documented liver involvement of their disease).
- Serum creatinine ≤ 1.5 × ULN, Estimated Creatinine clearance rate (Clcr) by the Cockcroft-Gault (C-G) equation ≥ 60 mL/min or estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) equation ≥ 60 mL/min.
- Urinary protein negative or trace (±); or urinary protein ≥ 1+ but with a urine protein to creatinine ratio (UPCR) in a morning spot urine sample < 0.5 or a 24-hour urine protein < 0.5 g/24 h.
- International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Subjects with stable anticoagulation treatment is allowed.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in section 10.4 Appendix 4 of the full protocol.
- OR
- A WOCBP who agrees to follow the contraceptive guidance in section 10.4 Appendix 4 of the full protocol during the treatment period and through 3 months after the last dose of study treatment.
Who cannot join
- Has had major surgery or significant traumatic injury within 28 days prior to randomization, or diagnostic biopsies within 14 days prior to randomization.
- Note: Subjects with anticipation of the need for major surgery during study treatment should be excluded. Subjects who underwent diagnostic biopsy within 14 days prior to randomization may also be enrolled if the investigator and sponsor determine that the diagnostic biopsy will not affect the efficacy evaluation.
- Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, macromolecular drugs (eg., bevacizumab) or investigational drugs prior to randomization.
- Has received prior radiotherapy within 14 days prior to randomization. Note: A 7-day washout is permitted for palliative radiation (≤ 14 days of radiotherapy) to non-central nervous system (CNS) disease.
- Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
- Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to randomization, except for curatively treated cancers such as cervical/breast/prostate carcinoma in situ and basal cell carcinoma.
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- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Note: Subjects with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks apart by repeat imaging (note that the repeat imaging should be performed during screening phase) for at least 28 days prior to randomization.
- Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months before randomization, or has any of the following abnormality:
- QTc interval corrected using Fridericia's formula > 470 ms (based on QTcF).
- Left ventricular ejection fraction (LVEF) < 50%.
- New York Heart Association (NYHA) functional classification ≥ Grade 2.
- Clinically significant arrhythmia.
- Uncontrolled hypertension or diabetes.
- Other clinically significant heart diseases.
- Has known pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms or requiring puncture or drainage. Subjects who received drainage within the first 3 months of randomization should be excluded. A small amount of ascites that can only be detected by imaging examination and without clinical symptom is allowed.
- Has malabsorption syndrome or inability to take oral drugs.
- Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding.
- Clinical or radiographic evidence of intestinal obstruction, or aetiology of previous recurrent ileus not excluded.
- Currently have interstitial pneumonia (except for radiation pulmonary fibrosis that does not require hormonal therapy).
- Has not well controlled active infection after systemic therapy.
- Has known human immunodeficiency virus (HIV) infection or known active Hepatitis B or Hepatitis C virus infection.
- Note: No HIV, Hepatitis B and Hepatitis C testing is required unless mandated by local health authority and/or site.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
- Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients.
- Has received prior cumulative anthracycline dose of 550 mg/m2 or more.
- Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors/inducers within 14 days prior to randomization, or anticipation of the systemic treatment of these drugs during Treatment Phase.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College
Beijing
Lingying WU
About this study
Official title: A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
Read the detailed description
This is a multicenter, randomized, double-blind, Phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
Approximately 168 subjects will be enrolled into the study. Eligible subjects will be randomized in a 2: 1 ratio to receive IN10018 in combination with PLD treatment (Experimental Arm, N = approx. 112) or placebo of IN10018 in combination with PLD (Control Arm, N = approx. 56). Subjects will be stratified by prior bevacizumab use (yes or no) and platinum free interval (PFI, < 3 months or 3-6 months).
Subjects will be randomized to one of following treatment arms. The investigator should follow the clinical study protocol, the approved label of these drugs and/or institutional standard of care.
- Experimental Arm: IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).
- Control Arm: Placebo of IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- IN10018, Placebo of IN10018, Pegylated Liposomal Doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN10018Drug
Also called BI 853520
100mg QD orally (PO)
Placebo of IN10018Drug
100mg QD orally (PO)
Pegylated Liposomal DoxorubicinDrug
Also called PLD
40 mg/m2 once every 4 weeks (Q4W) intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | IN10018+PLD Receives: Drug: IN10018; Drug: Pegylated Liposomal Doxorubicin |
| Control Arm | Placebo comparator | Placebo of IN10018+PLD Receives: Drug: Placebo of IN10018; Drug: Pegylated Liposomal Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
PFS per RECIST 1.1, as assessed by BICR.
Measured: 2 years.
Secondary outcomes (6)
Overall survival (OS), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
OS
Measured: 3 years.
Progression-free survival (PFS) per RECIST 1.1, as assessed by investigator , following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Defined as the proportion of subjects with complete response (CR) or partial response (PR)
Measured: 2 years.
Objective response rate (ORR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Defined as the proportion of subjects with complete response (CR) or partial response (PR)
Measured: 2 years.
Disease control rate (DCR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Defined as the proportion of patients with CR, PR, or stable disease (SD).
Measured: 2 years.
Duration of response (DoR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.
Measured: 2 years.
Safety and tolerability of IN10018 in combination with PLD vs. placebo in combination with PLD.
The number of participants who experienced AEs is presented.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start6 Sep 2022
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment allocation/randomization will be stratified according to the following factors: 1. Prior bevacizumab use (yes or no). 2. Platinum free interval (PFI, \< 3 months or 3-6 months), 3 months is defined as 90 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lingying WU, Principal investigator, Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014528
- Sponsor's protocol ID
- IN10018-011
- Status last verified
- Apr 2025
- First submitted
- 17 Aug 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06014528
- Acronym / sponsor ID
- IN10018-011
- Conditions
- Ovarian Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
Detailed description
This is a multicenter, randomized, double-blind, Phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
Approximately 168 subjects will be enrolled into the study. Eligible subjects will be randomized in a 2: 1 ratio to receive IN10018 in combination with PLD treatment (Experimental Arm, N = approx. 112) or placebo of IN10018 in combination with PLD (Control Arm, N = approx. 56). Subjects will be stratified by prior bevacizumab use (yes or no) and platinum free interval (PFI, < 3 months or 3-6 months).
Subjects will be randomized to one of following treatment arms. The investigator should follow the clinical study protocol, the approved label of these drugs and/or institutional standard of care.
- Experimental Arm: IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).
- Control Arm: Placebo of IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment allocation/randomization will be stratified according to the following factors: 1. Prior bevacizumab use (yes or no). 2. Platinum free interval (PFI, < 3 months or 3-6 months), 3 months is defined as 90 days.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: IN10018, Drug: Pegylated Liposomal DoxorubicinIN10018+PLD |
| Control Arm | Placebo comparator | Drug: Placebo of IN10018, Drug: Pegylated Liposomal DoxorubicinPlacebo of IN10018+PLD |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures, except those procedures used as institutional standard of care falling into the protocol specified window and fulfilling study specific requirements such as tumor imaging.
- Female subjects ≥ 18 years at the time of signing informed consent.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma (HGSC).
- Have received platinum containing therapy and have radiological relapse or progression during platinum containing treatment or < 6 months (184 calendar days) after completion of prior platinum-based therapy (at least 4 cycles).
- Note: Disease progression or recurrence requires evidence of radiographic or clinical progression (e.g., new ascites or cytological reports of pleural fluid), and elevated CA125 alone is not a criterion for progression or recurrence. Primary platinum-refractory ovarian cancers (defined as progression during or within 4 weeks after first line platinum-based therapy) is excluded, while secondary platinum-refractory disease is allowed and does not require at least 4 cycles of platinum-based therapy.
Key exclusion criteria (28 listed)
- Has had major surgery or significant traumatic injury within 28 days prior to randomization, or diagnostic biopsies within 14 days prior to randomization.
- Note: Subjects with anticipation of the need for major surgery during study treatment should be excluded. Subjects who underwent diagnostic biopsy within 14 days prior to randomization may also be enrolled if the investigator and sponsor determine that the diagnostic biopsy will not affect the efficacy evaluation.
- Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, macromolecular drugs (eg., bevacizumab) or investigational drugs prior to randomization.
- Has received prior radiotherapy within 14 days prior to randomization. Note: A 7-day washout is permitted for palliative radiation (≤ 14 days of radiotherapy) to non-central nervous system (CNS) disease.
- Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN10018Also: BI 853520100mg QD orally (PO) | Drug | Experimental Arm |
| Placebo of IN10018100mg QD orally (PO) | Drug | Control Arm |
| Pegylated Liposomal DoxorubicinAlso: PLD40 mg/m2 once every 4 weeks (Q4W) intravenously (IV) | Drug | Control Arm, Experimental Arm |
Primary outcome
Progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Time frame: 2 years.
PFS per RECIST 1.1, as assessed by BICR.
6 secondary outcomes
Overall survival (OS), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Time frame: 3 years.
Progression-free survival (PFS) per RECIST 1.1, as assessed by investigator , following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Time frame: 2 years.
Objective response rate (ORR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Time frame: 2 years.
Disease control rate (DCR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Time frame: 2 years.
Duration of response (DoR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Time frame: 2 years.
Safety and tolerability of IN10018 in combination with PLD vs. placebo in combination with PLD.
Time frame: 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lingying WU principal investigator
Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IN10018 and Pegylated Liposomal Doxorubicin in people with Ovarian Cancer Recurrent, run by InxMed (Shanghai) Co., Ltd. at 1 site in China.
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 26 inclusion and 28 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 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 Shangyu CHEN, N/A (+86 18752093074, shangyu.chen@inxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD. (time frame: 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.