Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
- Conditions
- Endometrial CAGastric CAProstate CAOvarian CAColorectal CAUrothelial CABiliary Tract CA
- Registration Number
- JPRN-jRCT2031220404
- Lead Sponsor
- Inoguchi Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 670
Male and female, >= 18 years
Documented advanced or metastatic malignancy
Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing
All participants must provide a tumour sample for tissue-based analysis
At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease
Adequate bone marrow reserve and organ function
Minimum life expectancy of 12 weeks
At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
All women of childbearing potential must have a negative serum pregnancy test documented during screening
Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study
Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.
Capable of giving signed informed consent
Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative
Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol
History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent
Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved
Spinal cord compression or brain metastases unless treated
Leptomeningeal carcinomatosis
Clinically significant corneal disease
Active hepatitis or uncontrolled hepatitis B or C virus infection
Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms
Known HIV infection that is not well controlled
Active TB infection
Significant cardiac diseases
History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required steroids
Has severe pulmonary function compromise
Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention
Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment
Major surgical procedure or significant traumatic injury within <= 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
Prior treatment with TROP2-directed Anti-drug antibody, ADC Antibody-drug conjugate (ADCs), other ADCs with deruxtecan payload
Severe hypersensitivity to monoclonal antibodies
Pregnant, breastfeeding, planning to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR)<br>The number of subjects with adverse events/serious adverse events<br>PSA50 response (Substudy 3 only)
- Secondary Outcome Measures
Name Time Method