Trial Title:
IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients
NCT ID:
NCT05830539
Condition:
Locally Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Doxorubicin
Liposomal doxorubicin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IN10018+PLD
Description:
IN10018 orally once daily; PLD 40mg/m2, Q4W
Arm group label:
Head and Neck Squamous Cell Cancer(R/M-HNSCC)
Arm group label:
Other solid tumor
Arm group label:
Triple Negative Breast Cancer(TNBC)
Other name:
IN10018 and Doxorubicin Hydrochloride Liposome Injection
Intervention type:
Drug
Intervention name:
IN10018+PLD+Toripalimab
Description:
IN10018 orally once daily; PLD 40mg/m2, Q4W; Toripalimab 3 mg/kg, Q2W
Arm group label:
Head and Neck Squamous Cell Cancer(R/M-HNSCC)
Arm group label:
Other solid tumor
Arm group label:
Platinum-resistant Ovarian Cancer
Arm group label:
Platinum-sensitive Ovarian Cancer(PSOC)
Arm group label:
Small Cell Lung Cancer(SCLC)
Arm group label:
Triple Negative Breast Cancer(TNBC)
Other name:
IN10018 and Doxorubicin Hydrochloride Liposome Injection and Toripalimab
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria
1. Male or female, and aged 18 - 75 years at the time of signing the informed consent.
2. Has ability to understand and willingness to sign informed consent(s).
3. 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.
4. Have received at least 1 line of standard therapy for locally advanced or metastatic
solid tumors and have failed or are not tolerable.
5. At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed
by investigator.
6. ECOG performance status of 0 or 1.
7. Life expectancy of at least 3 months as assessed by investigator.
8. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to
first dose of study treatment.
9. 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
1. 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.
2. Has received prior systemic anticancer therapy such as chemotherapy, biological
therapy, endocrine therapy, immunotherapy, etc. within 4 weeks before the first
dose.
3. 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.
4. Has interstitial pneumonia currently.
5. Has received prior treatment of any FAK inhibitor.
6. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
7. Has a prior history of malignancy other than the study disease.
8. 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.
9. Has malabsorption syndrome or inability to take oral medication.
10. 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.
11. Has any active infection requiring systemic therapy within 14 days prior to the
first dose of study treatment.
12. 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.
13. Known allergy or hypersensitivity to IN10018, PLD, or Toripalimab or their
ingredients.
14. Pregnant or lactating women.
15. Has received prior cumulative doxorubicin or equivalent anthracyclines doses of 360
mg/m2 or more.
16. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anyang Tumor Hospital
Address:
City:
Anyang
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Facility:
Name:
The Third Hospital of Nanchang
Address:
City:
Nanchang
Country:
China
Facility:
Name:
Obstetrics & Gynecology Hospital of Fudan University
Address:
City:
Shanghai
Country:
China
Start date:
March 10, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
InxMed (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
InxMed (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830539
