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CTRI Number  CTRI/2025/03/081639 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   The clinical trial to study the effects of Naptumomab Estafenatox in Combination with Durvalumab (MEDI4736) in Subjects with Selected Advanced or Metastatic Solid Tumors 
Scientific Title of Study   Phase 1b, Open-label, Dose Escalation and Cohort Expansions Trial of Naptumomab Estafenatox (NAP, ABR-217620) in Combination with Durvalumab (MEDI4736) in Subjects with Selected Advanced or Metastatic Solid Tumors 
Trial Acronym  127-CL-01(NT-NAP-101) 
Secondary IDs if Any  
Secondary ID  Identifier 
127-CL-01 (NT-NAP-101) Version: 8.0 dated 20 March 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Radhika Inapakolla 
Designation  Overall Trial Coordinator 
Affiliation  CliNovi Research Pvt. Ltd. 
Address  1st&2ndfloorBurgerking buildingSurveyNo81/7&8Mithran MallMumbaiBangaloreHighwayTathawadePune411033MaharashtraIndia

Pune
MAHARASHTRA
411033
India 
Phone  9765800495  
Fax    
Email  radhika@clinovi.com  
 
Details of Contact Person
Scientific Query  
Name  Radhika Inapakolla 
Designation  Overall Trial Coordinator 
Affiliation  CliNovi Research Pvt. Ltd. 
Address  1st&2ndfloorBurgerking buildingSurveyNo81/7&8Mithran MallMumbaiBangaloreHighwayTathawadePune411033MaharashtraIndia

Pune
MAHARASHTRA
411033
India 
Phone  9765800495  
Fax    
Email  radhika@clinovi.com  
 
Details of Contact Person
Public Query  
Name  Radhika Inapakolla 
Designation  Overall Trial Coordinator 
Affiliation  CliNovi Research Pvt. Ltd. 
Address  1st&2ndfloorBurgerking buildingSurveyNo81/7&8Mithran MallMumbaiBangaloreHighwayTathawadePune411033MaharashtraIndia

Pune
MAHARASHTRA
411033
India 
Phone  9765800495  
Fax    
Email  radhika@clinovi.com  
 
Source of Monetary or Material Support  
NeoTX Therapeutics Ltd 2 Pekeris Street Rehovot 7670202, Israel 
 
Primary Sponsor  
Name  NeoTX Therapeutics Ltd 
Address  2 Pekeris Street Rehovot 7670202, Israel 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
CliNovi Research Pvt Ltd  Sr. No. 81/7 Mithran Mall, Mumbai Bangalore highway Tathawade, Pune, MH, India 411 033  
 
Countries of Recruitment     India
Israel
United States of America  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj Mahajan  Pacific Medical College & Hospital (PMCH)  Department of Oncology,room no. 108 Bhllo ka Bedla, Teh. Glrwa, Pratap Pura, Udaipur - 373001, Rajasthan
Udaipur
RAJASTHAN 		 0294-3520000

drmanoj.mahajan@gmail.com 
Dr Chethan R  All India Institute of Medical Sciences  Department of Oncology/Oncology/Room no.205 Ansari Nagar, New Delhi - 110029, India
New Delhi
DELHI 		 11-26588500

Chethan2190@gmail.com 
Dr Saphalta Baghmar  Amrita Hospital  Department of Oncology second floor Mata Amritanandamayi Marg, Sector-88 Faridabad 121002 (Haryana)
Faridabad
HARYANA 		 0129-3521234

saphaltab@fbd.amrita.edu 
Dr Keechilat Pavithran  Amrita Institute of Medical Science Kochi  Department of Oncology third floor AIMS Ponekkara P O, Edappally, Ernakulam, Kochi – 682041, Kerala, India
Ernakulam
KERALA 		 04842851234

pavithranK@aims.amrita.ado 
Dr Senthil Jagannathan Rajappa  Basavatarakam Indo-American Cancer Hospital & Research Institute  Department of Oncology/Room No. 10, Banjara Hills, Hyderabad- 500034, Telangana, India
Hyderabad
TELANGANA 		 040-23551235

Senthiljrajappa@gmail.com 
Dr Satya Pal Kataria  Medanta Hospital  Department of Oncology Medanta - The Medicity, 10th Floor, A-wing (POCU), Medanta - The Medicity, Sector-38, Gurugram - 122001, Haryana, India
Gurgaon
HARYANA 		 01244141414

raman.sehgel@medanta.org 
Dr Akash Kumar Jha  National Cancer Institute  Department of Oncology Room No.104 Badsa, Jhajjar-124105, Haryana, India
Jhajjar
HARYANA 		 918976983747

akashjha08@yahoo.com 
Dr Viraj Lavingia  Shalby Multi-Speciality Hospital Ahmedabad  Department of Oncology fourth floor Opp. Karnavati Club, S.G. Highway, Ahmedabad - 380015, Gujarat, India
Ahmadabad
GUJARAT 		 09924067400

drvirajlavingia@gmail.com 
Dr Anant Ramaswamy  Tata Memorial Hospital  Department of Oncology,third floor Dr. Ernest Borges Road, Parel, Mumbai- 400012, India
Mumbai
MAHARASHTRA 		 02224177000

anantr13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee - Shalby Limited, Shalby Hospital  Approved 
Institutional Ethics Committee Amrita Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee, All India Institute of Medical Sciences  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Amrita Hospital  Submittted/Under Review 
Institutional Ethics Committee, Basavatarakam Indo-American Cancer Hospital & Research Institute  Approved 
Institutional Ethics CommitteeI and IITata Memorial Hospital  Submittted/Under Review 
Institutional Human Ethics Committee of PMCH, Pacific Medical College  Approved 
Medanta Institutional Ethics Committee (MIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X||New Technology,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Naptumomab Estafenatox  Naptumomab Estafenatox will be administered in dose of 10 ug/ kg/day by IV bolus on day 1 through day 4 of first 6 treatment cycles and day 1 only starting cycle 7 till cycle 28 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  i. Group 1 no prior CPI: Subjects with only ESCC who may have received up to 1 prior chemotherapy as a line for metastatic disease or up to 2 prior chemotherapies if they also received neoadjuvant/adjuvant systemic therapy, but no prior CPI.
a. If subjects received prior chemotherapy for metastatic disease, they should have documented radiographic or clinical progression.
ii. Group 2 -prior CPI:

a. Subjects with either ESCC or AC or GEJ (Siewert type 1) who must not have had more than 2 prior lines of therapy. Patients will be allowed to have up to 2 prior regimens for metastatic disease, or up to 3 prior therapies if they also received neoadjuvant/adjuvant systemic therapy.
b. Subjects are eligible provided that they have received CPI therapy for at least 9 weeks, provided that they have documented progression of their disease on such therapy, and provided that prior CPI was not discontinued for toxicity.
c. No more than 1 prior checkpoint inhibitor treatment is allowed (prior combination of anti-PD-(L) 1 and anti-CTLA-4 is acceptable).
d. Subjects with adenocarcinoma that are HER-2/neu negative
 
 
ExclusionCriteria 
Details  Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF), myocardial infarction, or acute coronary syndrome within 6 months prior to study enrollment, ongoing angina pectoris, severe peripheral vascular disease, cerebrovascular accident (CVA) within 6 months of study entry, or any other concomitant medical disorder that might interfere with the subject’s participation in the study or interpretation of the study data.
8. Subjects who have undergone major surgery or trauma within 4 weeks of study entry.
9. Recent history of live attenuated vaccine within 28 days prior to obinutuzumab. NOTE: Patients, once enrolled, should not receive live vaccine whilst receiving study drug and up to 30 days after the last dose of study drug.
10. Known current drug or alcohol abuse.
11. Known active or latent tuberculosis (TB) infection (purified protein derivative [PPD] test is not required) as indicated by any of the following: PPD recently converted to positive; chest x-ray with evidence of infections infiltrate.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. ORR by (iRECIST) of the combination of NAP with durvalumab in subjects with advanced/metastatic:
a) squamous cell carcinoma of the esophagus without exposure to prior anti-PD-1/PD-L1 therapy, and b) squamous cell carcinoma or adenocarcinoma of the esophagus or the esophago-gastric junction, who have received prior anti-PD-1/PDL1
therapy. 		 over the period of 24 months and 28 cycles  
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess clinical activity in terms of overall survival (OS),
progression-free survival (PFS), duration of response (DOR) and
rate & duration of disease control in patients with CR, PR, or
stable disease (SD), in each group.
2. To assess the safety & tolerability of the combination of NAP
with durvalumab in subjects with advanced/metastatic carcinoma
of the esophagus. 		 1. To assess clinical activity in terms of overall survival (OS),
progression-free survival (PFS), duration of response (DOR) and
rate & duration of disease control in patients with CR, PR, or
stable disease (SD), in each group.
 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="31" 
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 
Date of First Enrollment (India)   17/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/07/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Other (Terminated) 
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  

To assess the Efficacy, safety and tolerability of Naptumomab Estafenatox/ Durvalumab in Esophageal cancer patients.

Rational for the Combination of NAP and Durvalumab for the Treatment of Esophageal Cancer

While a few early-phase trials have taken place in India for cancer research, this study can provide a solid foundation for future research. Particularly in the case of current trial, where safety profile for NAP in combination with durvalumab, has already been well established at the recommended phase 2 dose (RP2D), and this is a cohort expansion that will be conducted globally in the India US and Israel.

NAP recognizes the 5T4 antigen and induces T-cell-mediated killing of tumor cells. The therapeutic effect of NAP is associated with activation of SAg-binding T cells. The SAg-binding T lymphocytes expand, differentiate into effector cells, and infiltrate the tumor.

This effect of NAP makes it an ideal drug for combination with checkpoint inhibitors since recognition is not only a requirement for the initial response of checkpoint inhibitors but loss of recognition is also a major cause of acquired resistance.


 
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