gynecologic tumors
Conditions
Interventions
Cohort A:JS105 in combination with Paclitaxel (albumin-bound)
Cohort B:JS105 in combination with Toripalimab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.All participants must sign an informed consent form (ICF) before starting any study-related procedures. 2.Must be =18 years old at the time of signing the ICF; both males and females are eligible. 3.Histologically or cytologically confirmed diagnosis of recurrent/metastatic advanced gynecologic cancers (including epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, and cervical cancer) with disease progression after receiving at least one line of systemic therapy or intolerance to standard treatment. 4.Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1. 5.At least one measurable lesion confirmed within 28 days prior to enrollment according to RECIST 1.1 criteria. 6.Expected survival time of =3 months. 7.Male participants and females of childbearing potential must use contraception from the first dose of the study drug until 90 days after the last dose of the study drug. 8.Adequate organ function before the first dose of the study drug, with laboratory test results meeting the required conditions.
Exclusion criteria
Exclusion criteria: 1.Patients known to be allergic to components of JS105 or known to be allergic to other investigational drugs; 2.Patients who have previously received treatment with PI3K, mTOR, or AKT inhibitors; 3.Participation in another clinical study within 4 weeks prior to the first dose, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study; 4.Underwent major surgery within 4 weeks prior to the first dose or currently in the recovery phase, or expected to undergo major surgery during the study period; 5.Received systemic anti-tumor therapy within 4 weeks prior to the first dose, such as chemotherapy (6 weeks for nitrosoureas or mitomycin; 14 days or 5 half-lives, whichever is longer, for oral fluoropyrimidines), radiotherapy, targeted therapy (14 days or 5 half-lives, whichever is longer, for small molecule targeted drugs), immunotherapy, or biological therapy; received endocrine therapy, traditional Chinese medicine, or Chinese patent medicine with anti-tumor indications within 2 weeks prior to the first dose; local palliative treatment (such as local surgery or radiotherapy) for isolated lesions is allowed if it does not affect efficacy evaluation; 6.Has not recovered from the toxicities of previous anti-tumor treatments, defined as not having returned to baseline or NCI-CTCAE v5.0 Grade 1 levels; irreversible toxicities that are not expected to be exacerbated by the investigational drug (e.g., hearing loss, alopecia, pigmentation, etc.) may be allowed for enrollment after consultation with the medical monitor. 7. Administration of live attenuated vaccine, mRNA vaccine, or adenovirus vector vaccine within 30 days prior to the first dose 87. Administration of live attenuated vaccine, mRNA vaccine, or adenovirus vector vaccine within 30 days prior to the first dose 87. Administration of live attenuated vaccine, mRNA vaccine, or adenovirus vector vaccine within 30 days prior to the first dose 8. Presence of uncontrolled or symptomatic active central nervous system metastases; S. Presence of uncontrolled or symptomatic active central nervous system metastases; S. Presence of uncontrolled or symptomatic active central nervous system metastases; Subjects with previously treated asymptomatic brain metastases who meet all of the following criteria are eligible to participate in this study: Supratentorial metastases and/or cerebellar metastases only (i.e., no metastases in the midbrain, pons, bulbar or spinal cord); Cubjects with previously treated asymptomatic brain metastases who meet all of the following criteria are eligible to participate in this study: Supratentorial metastases and/or cerebellar metastases only (i.e., no metastases in the midbrain, pons, bulbar or spinal cord); Cubjects with previously treated asymptomatic brain metastases who meet all of the following criteria are eligible to participate in this study: Supratentorial metastases and/or cerebellar metastases only (i.e., no metastases in the midbrain, pons, bulbar or spinal cord); Corticosteroid therapy needs to be discontinued for at least 7 days prior to study drug administration; Norticosteroid therapy needs to be discontinued for at least 7 days prior to study drug administration; Norticosteroid therapy needs to be discontinued for at least 7 days prior to study drug administration; No disease progression was detected after the end of brain-directed therapy until the screening period for randomization enrollme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose;RP2D;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival;Disease control rate;Duration of Response;Overall survival; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center
Outcome results
None listed