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Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT05830539

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

A Phase 1/2 study testing IN10018+PLD and IN10018+PLD+Toripalimab in people with Locally Advanced or Metastatic Solid Tumors, run by InxMed (Shanghai) Co., Ltd. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IN10018+PLD and IN10018+PLD+Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
7 sitesChina
Study dates
10 Mar 2022to 22 Nov 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Cohort 1: Histologically-confirmed Locally advanced or metastatic triple-negative breast cancer.
  • Cohort 2: Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma.
  • 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.
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  • Cohort 5: Histologically confirmed extensive-stage small cell lung cancer (according to the Veteran's Administration Lung Cancer Study Group (VALG) classification system).
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Anyang Tumor Hospital

    Anyang, Henan

  • Hunan Cancer Hospital

    Changsha, Hunan

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase Ib/II, Open-label, Multicenter Clinical Study to Evaluate the Antitumor Activities, Safety, and Tolerability of IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients

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.

Being tested
IN10018+PLD, IN10018+PLD+Toripalimab

What participants receive

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

  • IN10018+PLDDrug

    Also called IN10018 and Doxorubicin Hydrochloride Liposome Injection

    IN10018 orally once daily; PLD 40mg/m2, Q4W

  • IN10018+PLD+ToripalimabDrug

    Also called IN10018 and Doxorubicin Hydrochloride Liposome Injection and Toripalimab

    IN10018 orally once daily; PLD 40mg/m2, Q4W; Toripalimab 3 mg/kg, Q2W

Study groups in NCT05830539
Study groupRoleWhat they receive
Triple Negative Breast Cancer(TNBC)ExperimentalGroup 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.
Receives: Drug: IN10018+PLD; Drug: IN10018+PLD+Toripalimab
Head and Neck Squamous Cell Cancer(R/M-HNSCC)ExperimentalGroup 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.
Receives: Drug: IN10018+PLD; Drug: IN10018+PLD+Toripalimab
Platinum-resistant Ovarian CancerExperimentalGroup 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with platinum-resistant ovarian cancer.
Receives: Drug: IN10018+PLD+Toripalimab
Platinum-sensitive Ovarian Cancer(PSOC)ExperimentalGroup 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with Platinum-sensitive recurrent ovarian cancer.
Receives: Drug: IN10018+PLD+Toripalimab
Small Cell Lung Cancer(SCLC)ExperimentalGroup 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic SCLC.
Receives: Drug: IN10018+PLD+Toripalimab
Other solid tumorExperimentalGroup 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.
Receives: Drug: IN10018+PLD; Drug: IN10018+PLD+Toripalimab

What is being measured

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

  1. 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.

    Measured: Up to 6 Months

  2. 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).

    Measured: Up to 24 Months

Secondary outcomes (5)

  1. 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.

    Measured: Up to 24 Months

  2. 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.

    Measured: Up to 24 Months

  3. 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).

    Measured: Up to 24 Months

  4. 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.

    Measured: Up to 24 Months

  5. 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.

    Measured: Up to 36 Months

Timeline

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

  1. First posted26 Apr 2023
  2. Study start10 Mar 2022
  3. Primary completion31 Aug 2024
  4. Study completion22 Nov 2024

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
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05830539
Sponsor's protocol ID
IN10018-010
Status last verified
Apr 2025
First submitted
31 Mar 2023
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IN10018+PLD and IN10018+PLD+Toripalimab in people with Locally Advanced or Metastatic Solid Tumors, run by InxMed (Shanghai) Co., Ltd. at 7 sites 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 14 inclusion and 16 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: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose (RP2D) of IN10018 in combination with PLD and anti-PD-1 monoclonal antibody. (time frame: Up to 6 Months). The study lists 2 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 NCT05830539.

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 May 2025.

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