| CTRI Number |
CTRI/2024/12/078409 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Novel Imaging study of breast, renal and lung cancers |
|
Scientific Title of Study
|
Phase I Imaging Study of 68Ga-R10306 in Breast Cancer, Renal Cell Carcinoma, and Non-Small Cell Lung Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| R10306-101 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumar G Kallur |
| Designation |
Director, Department of Nuclear Medicine |
| Affiliation |
HealthCare Global Enterprises Ltd. |
| Address |
Room No 1, Department of Nuclear Medicine, Tower 1, Ground Floor, No 8, P Kalingarao Road, Sampangi Ram Nagar
Bangalore
KARNATAKA
560027
India |
| Phone |
9844083662 |
| Fax |
|
| Email |
kumarkallur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar G Kallur |
| Designation |
Director, Department of Nuclear Medicine |
| Affiliation |
HealthCare Global Enterprises Ltd. |
| Address |
Room No 1, Department of Nuclear Medicine, Tower 1, Ground Floor, No 8, P Kalingarao Road, Sampangi Ram Nagar
KARNATAKA
560027
India |
| Phone |
9844083662 |
| Fax |
|
| Email |
kumarkallur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumar G Kallur |
| Designation |
Director, Department of Nuclear Medicine |
| Affiliation |
HealthCare Global Enterprises Ltd. |
| Address |
Room No 1, Department of Nuclear Medicine, Tower 1, Ground Floor, No 8, P Kalingarao Road, Sampangi Ram Nagar
KARNATAKA
560027
India |
| Phone |
9844083662 |
| Fax |
|
| Email |
kumarkallur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Radionetics Oncology Inc.
3033 Science Park Road, Suite 240, San Diego, CA 92121 |
|
|
Primary Sponsor
|
| Name |
Radionetics Oncology Inc. |
| Address |
3033 Science Park Road, Suite 240, San Diego, CA 92121 |
| Type of Sponsor |
Other [Radionucleotide Research Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kumar G Kallur |
HealthCare Global Cancer Center |
Nuclear Medicine Department, Tower 1 ground Floor, Room No.1, 8 P Kalingarao Road, Sampangi Ram Nagar
Bangalore
KARNATAKA |
9844083662
kumarkallur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, (3) ICD-10 Condition: C64||Malignant neoplasm of kidney, except renal pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
68 Ga Scan |
One-time PETCT Scan using Kisspeptin Receptor based Gallium68 |
| Comparator Agent |
FDG PET Scan |
One-Time PETCT Using conventional Fluorodeoxyglucose (FDG) PET |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- Cohort Specific Criteria
-- Cohort 1: Locoregionally recurrent or metastatic breast carcinoma with progressive disease.
-- Cohort 2: Metastatic clear cell renal cell carcinoma with progressive disease.
-- Cohort 3: Locally advanced or metastatic non-small cell lung cancer with progressive disease.
Common Criteria
- Availability of standard-of-care images within 28 days of dosing with 68Ga-R10306 (obtained in the same study center where the 68Ga-R10306 PET/CT is performed).
- At least one measurable target lesion per RECIST 1.1 criteria within 28 days of dosing with 68Ga-R10306.
- Male or non-pregnant, non-lactating females.
- Female Study Participants of child-bearing potential and male Study Participants (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
-- Medically acceptable adequate contraception for sexually active females with child-bearing potential include:
1) surgical sterilization (such as tubal ligation or hysterectomy),
2) approved hormonal contraceptives,
3) barrier method (such as condom or diaphragm) used with a spermicide, or
4) intrauterine device (IUD).
-- Medically acceptable adequate contraception for sexually active males include:
1) surgical sterilization (such as vasectomy),
2) a condom used with a spermicide.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- Adequate hepatic function as defined below (within 28 days of dosing with 68Ga-R10306):
a. Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or received prior mitotane therapy, and
b. Serum bilirubin – total ≤1.5 × ULN (unless due to Gilbert’s syndrome or hemolysis in which case total ≤3.0 × ULN).
- Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL/minute), determined within 28 days of dosing with 68Ga-R10306.
- Able to understand and willing to sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
1.Administered a radionuclide within a period corresponding to less than 10 physical half-lives of the radionuclide prior to dosing with 68Ga-R10306.
2.Radiotherapy ≤14 days prior to dosing with 68Ga-R10306.
3.Major surgery ≤21 days prior to dosing with 68Ga-R10306 or has not recovered from adverse effects of such procedure.
4.Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
5.History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
6.Major active infection requiring antibiotics.
7.Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
8.Acute illness within 14 days prior to dosing with 68Ga-R10306 unless mild in severity, as assessed by the Investigator.
9.Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety Assessments and Adverse Event Reporting |
Until 24 hours from the scan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 an
open-label, first-in-human, Phase 1 study of 68Ga-R10306 designed to
describe its safety and its biodistribution, and to compare its tumor lesion
detection with standard of care images in Study Participants with
locoregionally recurrent or metastatic breast cancer, renal cell carcinoma, and
with locally advanced or metastatic non-small cell lung cancer. 68Ga-R10306 is a gallium-labeled
small molecule radioligand agent that binds to the kisspeptin 1 receptor
(KISS1R), a G protein-coupled receptor. 68Ga-R10306 is being
developed to localize KISS1R-expressing lesions and identify Study Participants
with KISS1R-expressing tumors who may benefit from treatment with
KISS1R-targeting therapeutic agents. In healthy humans, KISS1R is found primarily
in the placenta, hypothalamus and pituitary, and plays a role in regulating
puberty and fertility |