IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer

NCT06014528 | Recruiting Phase 2 DMC

• 1 other identifier: IN10018-011
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ovarian Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years.

Secondary Outcomes (6)

• Overall survival (OS), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.

  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.

  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.

  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.

  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.

  2 years.

Other Outcomes (4)

• CA 125 response rate per Gynecological Cancer Intergroup (GCIG) criteria, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.

  2 years.

• PK: AUC0-τ of subjects receiving IN10018 and/or PLD treatment by serial and sparse PK samplings.

  2 years.

• PK: Ctrough of subjects receiving IN10018 and/or PLD treatment by serial and sparse PK samplings.

  2 years.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

IN10018+PLD

Drug: IN10018; Drug: Pegylated Liposomal Doxorubicin

Control Arm

PLACEBO COMPARATOR

Placebo of IN10018+PLD

Drug: Placebo of IN10018; Drug: Pegylated Liposomal Doxorubicin

Interventions

IN10018 DRUG

100mg QD orally (PO)

Also known as: BI 853520

Experimental Arm

Placebo of IN10018 DRUG

100mg QD orally (PO)

Control Arm

Pegylated Liposomal Doxorubicin DRUG

40 mg/m2 once every 4 weeks (Q4W) intravenously (IV)

Also known as: PLD

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Interventions

liposomal doxorubicin; 1-dodecylpyridoxal

Study Officials

• Lingying WU

  Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shangyu CHEN, N/A

CONTACT

+86 18752093074; shangyu.chen@inxmed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a randomized, double-blind clinical study, therefore, investigator, site staff, subject, and sponsor involved in study will not know the treatment administered. In addition, the central imaging reviewer conducting the BICR evaluation will also be blinded to study treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 28, 2023
• Study Start: September 6, 2022
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)