Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: Sacituzumab vedotin (ZRC-3328) (Monotherapy): Strength :- 50 mg
Route :- Intravenous (infusion)
Duration : - 21 days cycle till 12 cycles or disease progression whichever is earlier.
Fr
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and/or female patients aged greater than equal to 18 years at the time of giving the informed consent. 2.Ability to understand, agree to, and voluntarily give a written informed consent form prior to initiation of any study specific procedures. In case of illiterate participants, thumb impression of the participants will be obtained along with the signature of the impartial witness on the consent form prior to participants participation in the trial. 3. Histologically or cytologically confirmed unresectable, locally advanced, or metastatic epithelial malignancy. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening. 5.Estimated life expectancy of greater than equal to 3 months as assessed by the Investigator. 6.Willingness and ability, as assessed by the Investigator, to comply with All protocol required procedures, Scheduled visits, Treatment administration, Laboratory evaluations, Imaging assessments, Follow-up requirements. 7.Individuals who are otherwise medically stable based on physical examination, medical history, vital signs, 12 lead ECG, and clinical laboratory tests performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator. Phase 1a Dose Escalation 1.Patients must have histologically or cytologically confirmed advanced or metastatic epithelial malignancy that is not amenable to curative treatment. 2.Preferably at least one measurable lesion as defined by RECIST version 1.1, confirmed by radiologic imaging within 28 days prior to enrolment.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or allergic reactions to monoclonal antibodies, MMAE, or any component of the investigational product formulation. 2.History of or active interstitial lung disease (ILD), drug-induced pneumonitis, or pulmonary fibrosis requiring systemic corticosteroids, clinically significant COPD, or other moderate-to-severe chronic respiratory illness. 3.Known history of organ transplantation (solid organ or allogeneic stem cell). 4.Receipt of live or live-attenuated vaccines within 28 days prior to the first dose of study drug, or planned during the study. 5.Documented medical history of a poorly controlled/clinically significant medical condition or laboratory parameters or other relevant medical disease, such as a neurological, psychiatric, pulmonary, gastrointestinal, or endocrine disease or a history of clinically significant hematological, renal, or liver disease or any other condition that, in the opinion of the investigator, would put the patient at risk by participation in the trial or deemed by the clinician to be likely to interfere with a participant s compliance and ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of TEAEs and DLTs (per NCI-CTCAE version 5.0 or above).Timepoint: DAy 1 - Day 21 to Day 30 post last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters including Cmax, AUC, T , CL, and Vd for total pharmacokinetic (PK), PK-ADC (Specific), free MMAETimepoint: Baseline to EOT;Objective response rate (ORR) and Disease Control Rate (DCR) per RECIST v1.1. Duration of Response (DoR), if applicableTimepoint: Baseline to EOT;Incidence and titres of ADATimepoint: Baseline to EOT;Incidence of NabTimepoint: Baseline to EOT | — |
Countries
India
Contacts
Public ContactDr Maulik Doshi MD DM
Zydus Lifesciences Limited
Outcome results
None listed