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

NCT05830539 | Completed Phase 1

• 1 other identifier: IN10018-010
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Up to 24 Months

Secondary Outcomes (5)

• Number of patients with adverse event; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG.

  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.

  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.

  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.

  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.

  Up to 36 Months

Study Arms (6)

Triple Negative Breast Cancer(TNBC)

EXPERIMENTAL

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

Head and Neck Squamous Cell Cancer(R/M-HNSCC)

EXPERIMENTAL

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

Platinum-resistant Ovarian Cancer

EXPERIMENTAL

Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with platinum-resistant ovarian cancer.

Drug: IN10018+PLD+Toripalimab

Platinum-sensitive Ovarian Cancer(PSOC)

EXPERIMENTAL

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

Small Cell Lung Cancer(SCLC)

EXPERIMENTAL

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

Other solid tumor

EXPERIMENTAL

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

IN10018+PLD DRUG

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

Also known as: IN10018 and Doxorubicin Hydrochloride Liposome Injection

Head and Neck Squamous Cell Cancer(R/M-HNSCC); Other solid tumor; Triple Negative Breast Cancer(TNBC)

IN10018+PLD+Toripalimab DRUG

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

Also known as: IN10018 and Doxorubicin Hydrochloride Liposome Injection and Toripalimab

Head and Neck Squamous Cell Cancer(R/M-HNSCC); Other solid tumor; Platinum-resistant Ovarian Cancer; Platinum-sensitive Ovarian Cancer(PSOC); Small Cell Lung Cancer(SCLC); Triple Negative Breast Cancer(TNBC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

Study Sites (7)

Anyang Tumor Hospital

Anyang, Henan, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

The Third Hospital of Nanchang

Nanchang, Jiangxi, China

Location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

toripalimab

Study Officials

• Lingying WU

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Xichun Hu

  Fudan University

  PRINCIPAL INVESTIGATOR

• Dongmei Ji

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 26, 2023
• Study Start: March 10, 2022
• Primary Completion: August 31, 2024
• Study Completion: November 22, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

CN (7)