CompletedNCT05830539Updated May 2, 2025

IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients

A Phase 1/2 interventional study of IN10018+PLD and IN10018+PLD+Toripalimab in Locally Advanced or Metastatic Solid Tumors, sponsored by InxMed (Shanghai) Co., Ltd.. Completed at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by InxMed (Shanghai) Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Registered 1 year after the study started (first participant enrolled Mar 2022, registered Mar 2023).

Phase: Phase 1/2
Study type: Interventional
Enrollment: 68
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This is a multicenter, open-label, Phase Ib/II clinical trial to evaluate the safety, tolerability, and antitumor efficacy of IN10018 in combination with pegylated liposomal doxorubicin (PLD) or IN10018 in combination with PLD and anti-PD-1 in subjects with locally advanced or metastatic solid tumors who have failed or not tolerated to at least first-line system therapy.

Read the detailed description

This study is a phase Ib/II, multicenter, open-label clinical study. This study consists of 2 parts: 1) Efficacy exploration part: including phase-Ib study (dose confirmation part) and phase II study, the purpose of phase Ib-dose confirmation part is to determine the Phase II recommended dose (RP2D) of IN10018 in combination with Pegylated liposomal doxorubicin (PLD) and programmed death-1 (PD-1) monoclonal antibody. The Phase II study will explore the antitumor efficacy and safety of IN10018 in combination with PLD or IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in subjects with locally advanced or metastatic solid tumors who have failed or are intolerant to at least first-line system therapy; 2) Efficacy confirmation part: The antitumor efficacy and safety of combination therapy in the corresponding solid tumors will be further confirmed.

Conditions studied

Locally Advanced or Metastatic Solid Tumors

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Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 68 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

InxMed (Shanghai) Co., Ltd. is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female, and aged 18 - 75 years at the time of signing the informed consent.
Has ability to understand and willingness to sign informed consent(s).
Histologically confirmed locally advanced or metastatic solid tumors:
1. Cohort 1: Histologically-confirmed Locally advanced or metastatic triple-negative breast cancer.
2. Cohort 2: Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma.
3. Cohort 3 and 4: Histologically confirmed epithelia ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma (HGSC) only.
4. Cohort 5: Histologically confirmed extensive-stage small cell lung cancer (according to the Veteran's Administration Lung Cancer Study Group (VALG) classification system).
5. Cohort 6: other Histologically confirmed locally advanced or metastatic solid tumors except cohort 1-5.
Have received at least 1 line of standard therapy for locally advanced or metastatic solid tumors and have failed or are not tolerable.
At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator.
ECOG performance status of 0 or 1.
Life expectancy of at least 3 months as assessed by investigator.
Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to first dose of study treatment.
Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.

Exclusion criteria

Has had major surgery or significant traumatic injury within 28 days prior to first dose of study treatment, or diagnostic biopsies within 14 days prior to first dose of study treatment.
Has received prior systemic anticancer therapy such as chemotherapy, biological therapy, endocrine therapy, immunotherapy, etc. within 4 weeks before the first dose.
History of autoimmune disease requiring systemic therapy within the past 2 years, including but not limited to autoimmune thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease.
Has interstitial pneumonia currently.
Has received prior treatment of any FAK inhibitor.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a prior history of malignancy other than the study disease.
Clinically symptomatic pleural effusion, pericardial effusion, or ascites, or those who have received or necessary for drainages within 3 months prior to the first dose of study treatment.
Has malabsorption syndrome or inability to take oral medication.
Has clinical or radiologic evidence of bowel obstruction, or prior recurrent bowel obstruction with the cause not eliminated within 3 months prior to the first dose of study treatment.
Has any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
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.
Known allergy or hypersensitivity to IN10018, PLD, or Toripalimab or their ingredients.
Pregnant or lactating women.
Has received prior cumulative doxorubicin or equivalent anthracyclines doses of 360 mg/m2 or more.
Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors/inducers within 14 days prior to the first dose of study treatment, or anticipation of the systemic treatment of these drugs during Treatment Phase.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 68 participants (actual)

Study arms

Experimental
Triple Negative Breast Cancer(TNBC)
Group 1: IN10018 in combination with PLD in Subjects with previously-treated locally advanced or metastatic TNBC. Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic TNBC.
Drug: IN10018+PLD · Drug: IN10018+PLD+Toripalimab
Experimental
Head and Neck Squamous Cell Cancer(R/M-HNSCC)
Group 1: IN10018 in combination with PLD in Subjects with previously-treated R/M-HNSCC. Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated R/M-HNSCC.
Drug: IN10018+PLD · Drug: IN10018+PLD+Toripalimab
Experimental
Platinum-resistant Ovarian Cancer
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with platinum-resistant ovarian cancer.
Drug: IN10018+PLD+Toripalimab
Experimental
Platinum-sensitive Ovarian Cancer(PSOC)
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with Platinum-sensitive recurrent ovarian cancer.
Drug: IN10018+PLD+Toripalimab
Experimental
Small Cell Lung Cancer(SCLC)
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic SCLC.
Drug: IN10018+PLD+Toripalimab
Experimental
Other solid tumor
Group 1: IN10018 in combination with PLD in Subjects with other previously-treated locally advanced or metastatic solid tumors. Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with other previously-treated locally advanced or metastatic solid tumors.
Drug: IN10018+PLD · Drug: IN10018+PLD+Toripalimab

Interventions

DrugIN10018+PLD
IN10018 orally once daily; PLD 40mg/m2, Q4W
Also known as: IN10018 and Doxorubicin Hydrochloride Liposome Injection
DrugIN10018+PLD+Toripalimab
IN10018 orally once daily; PLD 40mg/m2, Q4W; Toripalimab 3 mg/kg, Q2W
Also known as: IN10018 and Doxorubicin Hydrochloride Liposome Injection and Toripalimab

What researchers measure

Primary outcomes

Recommended phase II dose (RP2D) of IN10018 in combination with PLD and anti-PD-1 monoclonal antibody.
Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with PLD and Toripalimab.
Time frame: Up to 6 Months
Objective response rate (ORR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.
Defined as the proportion of subjects with complete response (CR) or partial response (PR).
Time frame: Up to 24 Months

Secondary outcomes

Number of patients with adverse event; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG.
Number of patients with adverse event; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG.
Time frame: Up to 24 Months
Duration of objective response (DOR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.
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.
Time frame: Up to 24 Months
Disease Control Rate (DCR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.
Defined as the proportion of patients with CR, PR, or stable disease (SD).
Time frame: Up to 24 Months
Progression-free survival (PFS) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.
Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Time frame: Up to 24 Months
Overall survival (OS) in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.
Defined as the time from the start of study treatment to the date of death due to any cause.
Time frame: Up to 36 Months

Study locations

7 sites

Anyang Tumor Hospital
Anyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05830539
Lead sponsor: InxMed (Shanghai) Co., Ltd.
Responsible party: Sponsor
First posted: Apr 26, 2023
Start date: Mar 10, 2022
Primary completion: Aug 31, 2024
Completion: Nov 22, 2024
Last update: May 2, 2025

Study contacts

Lingying WU

principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Xichun Hu

principal investigator · Fudan University

Dongmei Ji

principal investigator · Fudan University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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