TH1902 in Patients With Advanced Solid Tumors (NCT04706962) | Clinical Trial Compass
Active — Not RecruitingPhase 1
TH1902 in Patients With Advanced Solid Tumors
United States70 participantsStarted 2021-03-04
Plain-language summary
Open label first-in-human study of TH1902 in solid cancer, with 4 sequential parts:
Part 1 (dose escalation): patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies exist.
Part 2 (expansion): selected patient populations with recurrent advanced TNBC, HR+ breast cancer, epithelial ovarian cancer, endometrial cancer, cutaneous melanoma, thyroid cancer, SCLC, prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy.
Part 3 (optimization): patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer, including high grade peritoneal or fallopian tube cancer, or high grade endometrioid cancer, that is refractory or resistant to standard therapies, should not be considered platinum sensitive, and where current therapy is not considered to be providing benefit.
Part 4 (basket expansion): selected cancer type diagnosed with histologically or cytologically confirmed cancers, where TH1902 has been studied and/or showed activity (in Parts 1 to 3), that is refractory or resistant to standard therapies, and where current therapy is not considered to be providing benefit.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Are ≥18 years old males or females.
✓. Are capable of understanding and have voluntarily signed the informed consent document and willing to comply with study requirements.
✓. Have histologically or cytologically confirmed diagnosis of metastatic or advanced-stage solid tumor that is refractory to standard therapy (For Part 1 only; see modified inclusion criteria #13, 15 and 18 for Parts 2, 3, and 4, respectively).
✓. Have measurable disease according to the RECIST 1.1.
✓. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
✓. Have an expected survival of at least 3 months.
✓. Have a negative pregnancy test result confirmed by a serum beta-human chorionic gonadotropin (β-HCG) test (for women of childbearing potential \[WOCBP\]) performed at Screening and have a negative pregnancy urine test result on Cycle 1, Day 1. This is not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy, salpingectomy, tubal ligation and/or hysterectomy or postmenopausal or those that have had definitive radiation therapy to the pelvis. WOCBP are considered postmenopausal if 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels \> 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Timeframe: Through completion, an average of 12 weeks
✓. WOCBP who are sexually active with a non-sterilized male partner (sterilized males should be ≥6 months post vasectomy and have obtained documentation of the absence of sperm in the ejaculate) should agree to remain abstinent (refrain from sexual intercourse of any kind) or use 2 effective methods of contraception, including at least 1 method with a failure rate of \<1% per year, during the treatment period and for at least 6 months for both female and male patients, following the last dose of TH1902. Periodic abstinence (e.g., calendar, symptothermal, and post-ovulation), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.
Exclusion criteria
✕. Have received chemotherapy, biologic therapy, immunotherapy, radiotherapy (except palliative radiation delivered to \<20% of bone marrow), or investigational agents within 4 weeks before the first dose of study drug. Patients who have received targeted therapy (investigational or approved) must not have received their last dose within 4 weeks, or within 5 half-lives (whichever is shorter) prior to treatment with the study drug (Cycle 1, Day 1).
✕. Have known hypersensitivity to taxanes, including docetaxel, or to any excipients in the TH1902 study drug (e.g., polysorbate 80, predominantly known as Tween® 80).
✕. Have experienced severe toxicity with previous taxane treatment.
✕. Patients with leptomeningeal disease or spinal cord compression or active brain metastases are ineligible for enrollment. Patients with treated brain metastasis that are stable for 4 weeks or longer, and not requiring steroids, are eligible for treatment. Patients with history of brain metastasis should have a magnetic resonance imaging (MRI) within 4 weeks of initiating treatment. For patients where MRI is contraindicated (e.g., due to tissue expanders), brain computerized tomography (CT) may be obtained after discussion with Sponsor.
✕. Pregnant, breastfeeding, or planning to become pregnant during the treatment period.
✕. Had any acute viral (including COVID-19), bacterial, or fungal infection that requires parenteral therapy within 14 days prior to treatment with study drug (Cycle 1, Day 1).
✕. Have received a live vaccine within 30 days prior to administration of the study drug.
✕. Had treatment with cytochrome P450 CYP3A4 or CYP3A5 enzyme-inducing or enzyme inhibiting drugs within 14 days prior to treatment with the study drug (Cycle 1, Day 1).