NCT04480619

Brief Summary

This is a phase I/IIa, open label, multicenter interventional study of Gallium-68 radiolabeled Integrin Adhesion Complex antagonist conjugate (Ga-68-IAC) Positron Emission Tomography (PET/CT) imaging, intended for diagnosis, and clinical management of patients with Metastatic breast cancer.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
16mo left

Started Oct 2025

Geographic Reach
2 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Oct 2025Aug 2027

First Submitted

Initial submission to the registry

June 30, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
5.3 years until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

June 30, 2020

Last Update Submit

July 11, 2025

Conditions

Angiogenic Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-IAC in patients diagnosed with angiogenic breast cancer.

    Assess drug safety and tolerability measuring Incidence of adverse events. NCI Common Terminology Criteria for Adverse Events v5.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening

    6 Months

  • Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-IAC

    Assess drug safety and tolerability measuring incidence of abnormal vital signs. Vital signs will include measurements of respiratory rate, pulse rate, and systolic and diastolic blood pressure.

    6 Months

  • Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-IAC examination

    Assess drug safety and tolerability measuring incidence of abnormal physical examination findings. Physical examination will be summarized for each body system such as head, eyes, ears, nose, and throat, and cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems.

    6 Months

Secondary Outcomes (1)

  • Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-IAC

    6 Months

Study Arms (1)

Ga-68-IAC PET/CT

EXPERIMENTAL

Companion Ga-68 PET diagnostic for tumor targeted therapy

Diagnostic Test: Ga-68-IAC

Interventions

Ga-68-IACDIAGNOSTIC_TEST

Clinical management and diagnosis of Metastatic Breast Cancer.

Also known as: Ga-68-IAC PET/CT
Ga-68-IAC PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with solid tumors (either 3+ by immunohistochemistry or with evidence of gene amplification (\>2.0) by fluorescence in situ hybridization (FISH))
  • At least 18 years of age
  • Able to provide informed consent.
  • Karnofsky score greater than 50
  • Females of childbearing potential must have a negative pregnancy test at screening/baseline
  • AIP-301 Ga-68 positive scan define by SUV greater than 10.
  • Adequate organ function, defined as:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
  • Hemoglobin (Hb) ≥9 g/dl (transfusion or use of EPO is permitted).
  • Platelets \> 100,000/mm3
  • Creatinine ≤ 1.5 x normal value based on the Cock Gault (CG) equation.
  • AST or ALT ≤ 2.5 x ULN (or ≤5 x ULN in case of liver metastasis)
  • Alkaline phosphatase ≤2.5 x ULN. Alkaline phosphatase may be more than 2.5 x ULN only in the case of bone metastases, and AST and ALT less than 1.5 x ULN.
  • Total bilirubin ≤1.5 mg/dl (higher bilirubin levels are permitted if the patient has Gilbert's syndrome).
  • Baseline LVEF ≥50% measured using echocardiogram or equilibrium
  • +1 more criteria

You may not qualify if:

  • Serum creatinine \>3.0 mg/dL (270 μM/L)
  • Hepatic enzyme levels more than 5 times upper limit of normal.
  • Known severe allergy or hypersensitivity to IV radiographic contrast.
  • Use of any other investigational product or device within 30 days prior to dosing or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
  • Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
  • Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Recognized concurrent active infection (e.g., HIV)
  • Previous Grade 3 or higher allergic reaction to Trastuzumab that resulted in discontinuation of Trastuzumab therapy. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
  • Adult patients who require monitored anesthesia for PET scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Postgraduate Institute of Medical and Research

Chandigarh, India

Location

All India Institute of Medical Sciences

New Delhi, India

Location

University of Witwatersrand

Johannesburg, South Africa

Location

Related Publications (2)

  • Baum RP, Kulkarni HR, Muller D, Satz S, Danthi N, Kim YS, Brechbiel MW. First-In-Human Study Demonstrating Tumor-Angiogenesis by PET/CT Imaging with (68)Ga-NODAGA-THERANOST, a High-Affinity Peptidomimetic for alphavbeta3 Integrin Receptor Targeting. Cancer Biother Radiopharm. 2015 May;30(4):152-9. doi: 10.1089/cbr.2014.1747.

    PMID: 25945808RESULT

  • Kim YS, Nwe K, Milenic DE, Brechbiel MW, Satz S, Baidoo KE. Synthesis and characterization of alphavbeta(3)-targeting peptidomimetic chelate conjugates for PET and SPECT imaging. Bioorg Med Chem Lett. 2012 Sep 1;22(17):5517-22. doi: 10.1016/j.bmcl.2012.07.024. Epub 2012 Jul 14.

    PMID: 22853992RESULT

Central Study Contacts

Stanley Satz, Ph.D.

CONTACT

561-561 286-6842ssatz@advancedimagingprojects.com

Rose Satz

CONTACT

5617578666rsatz@advancedimagingprojects.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Ga-68-AC PET/CT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 21, 2020

Study Start

October 30, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data will be available after completion of clinical trial

Shared Documents
CSR
Time Frame
2 years

Locations

IN(2)ZA(1)