CTRI/2026/01/100358 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On:
20/04/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Other
Public Title of Study
A Study to Assess the Safety,tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of sacituzumab vedotin.
Scientific Title of Study
A Phase 1/2, Multicenter, Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of sacituzumab vedotin alone and in combination with anti- PD-1/PD-L1 monoclonal antibody in Patients with Advanced Epithelial Tumors
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SACI.25.001, Ver 02,14 Oct 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Deven V Parmar MD FCP
Designation
Chief Medical Officer & Head – Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
dparmar@zydustherapeutics.com
Details of Contact Person Scientific Query
Name
Dr Maulik Doshi MD DM
Designation
General Manager
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
Maulik.Doshi@zyduslife.com
Details of Contact Person Public Query
Name
Dr Maulik Doshi MD DM
Designation
General Manager
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
GUJARAT 382213 India
Phone
02717665555
Fax
Email
Maulik.Doshi@zyduslife.com
Source of Monetary or Material Support
Zydus Lifesciences Limited
Zydus Research Centre,
Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmedabad – 382213, Gujarat, India
Primary Sponsor
Name
Zydus Lifesciences Limited
Address
Zydus Research Centre,
Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmedabad – 382213, Gujarat, India
All India Institute of Medical Sciences, New Delhi
Room No- 160 A, Department of Medical Oncology, 1st Floor, Dr. B. R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, Block C1, Ansari Nagar East, New Delhi, Delhi 110029 New Delhi DELHI
9769030180
dr.sachinkhurana@gmail.com
Dr Kandappan Velavan
Erode Cancer Centre
Erode Cancer Centre, 1/393 Velavan nagar, perundurai road, thindal, Erode-638012
Erode TAMIL NADU
0424 2220030
KVELS@REDIFFMAIL.COM
Dr Raj Vasantrao Nagarkar
HCG Manavata Cancer centre
HCG Manavata Cancer Centre, Behind Shivang auto, Mumbai Naka, Nashik, Maharashtra, 422002
Nashik MAHARASHTRA
Rajkot Cancer Society Ethics Committee, Rajkot Cancer Society 1 Tirupatinagar, Hanuman Madhi Chowk, Raiya Road Rajkot Rajkot Gujarat - 360007
Approved
Sangini Hospital Ethics Committee,C/O Sangini Hospital, First floor, Santorini Square, B/h Abhishree complex,opp. Star Bazar Lane, Satellite, Ahmedabad-380015, Gujarat, India.
VMMC And SAFDARJUNG HOSPITAL, Ring Road Ansari Nagar New Delhi South Delhi, Delhi - 110029 lndia.
Submittted/Under Review
Spandana Oncology Centre, #919, New No - 68, 28th Main Road, 9th Block, Jayanaga, Bengaluru-560069, Karnataka, India,
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NA
NA
Intervention
Sacituzumab vedotin (ZRC-3328) (Monotherapy)
Strength :- 50 mg
Route :- Intravenous (infusion)
Duration : - 21 days cycle till 12 cycles or disease progression whichever is earlier.
Frequency : 21 days cycle
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence, nature, and severity of TEAEs and DLTs (per NCI-CTCAE version 5.0 or above).
DAy 1 - Day 21 to Day 30 post last dose
Secondary Outcome
Outcome
TimePoints
PK parameters including Cmax, AUC, T½, CL, and Vd for total pharmacokinetic (PK), PK-ADC (Specific), free MMAE
Baseline to EOT
Objective response rate (ORR) and Disease Control Rate (DCR) per RECIST v1.1. Duration of Response (DoR), if applicable
Baseline to EOT
Incidence and titres of ADA
Baseline to EOT
Incidence of Nab
Baseline to EOT
Target Sample Size
Total Sample Size="42" Sample Size from India="42" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 1/ Phase 2
Date of First Enrollment (India)
10/02/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a First-in-Human, Phase 1/2 study of sacituzumab vedotin aimed at characterizing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy in adult patients with advanced or metastatic epithelial tumors. The study has been designed with a stepwise approach Phase 1a (dose escalation) will determine the recommended dose range (RDR) of sacituzumab vedotin, both as monotherapy