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68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)

Primary Purpose

177Lu-DOTA-FAPI, 68Ga-DOTA-FAPI, Theranostic

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-DOTA-FAPI, 177Lu-DOTA-FAPI
Sponsored by
The First Affiliated Hospital of Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 177Lu-DOTA-FAPI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • [68Ga]Ga-DOTA-FAPI PET/CT Inclusion Criteria: (i) adult participants (aged 18 years or order); (ii) Confirmed presence of various types of locally advanced or metastatic cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis); (iii) Participant must have documented tumor progression during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment; (iv) participants who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. (v) Eastern Cooperative Oncology Group Performance Status ≤ 2; (vi) Participant must have completed prior therapy at least 1 month (washout period) prior to [68Ga]Ga DOTA-FAPI PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline;
  • Hematologic parameters defined as:

    (i)Absolute neutrophil count (ANC) ≥ 1000 cells/mm3; (ii)Platelet count ≥ 100,000/mm3; (iii)Hemoglobin ≥ 8 g/dL;

  • Blood chemistry levels defined as:

    (i) AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN); (ii) Total bilirubin ≤ 2 times ULN; (iii) Creatinine ≤ 2 times ULN; (iv) Anticipated life expectancy ≥ 6 months; (v) Able to remain motionless for up to 10-20 minutes per scan;

  • [177Lu]Lu-DOTA-FAPI therapy Inclusion Criteria: (i) Completion of entry into [68Ga]Ga-DOTA-FAPI PET study and completion of scan; (ii) CThe presence of at least one measurable disease by [68Ga]Ga-DOTA-FAPI PET/CT (SUVmax > 10-fold above normal lung or liver);
  • Exclusion Criteria:

    (i) 1.Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA); (ii)Participants with Class 3 or 4 NYHA Congestive Heart Failure (iii) Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding); (iv) Pregnant or lactating women; (v)Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks; (vi)Has an additional active malignancy requiring therapy within the past 2 years; (vii)Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy; (viii)Psychiatric illness/social situations that would interfere with compliance with study requirements; (ix)Cannot undergo PET/CT scanning because of weight limits (350 lbs); (x)INR>1.2; PTT>5 seconds above UNL

Sites / Locations

  • First affiliated hospital of xiamen universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

177Lu-DOTA-FAPI dose escalation therapy study

Recommended Phase 2 dose 177Lu-DOTA-FAPI therapy study

Arm Description

Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. Patients with sufficient lesion uptake of 68Ga DOTA-FAPI PET/CT will be offered therapy. Escalating doses of 30-150 mCi of 177Lu-DOTA-FAPI will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.

Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. 10 patients will be enrolled in the dose expansion cohort and received the highest dose achieved in the 177Lu-DOTA-FAPI dose escalation therapy study

Outcomes

Primary Outcome Measures

68Ga-DOTA-FAPI PET/CT imaging
Assessment of 68Ga-DOTA-FAPI PET/CT imaging to detect lesions in patients with various types of cancer (locally advanced or metastatic cancer)
[177Lu]Lu-DOTA-FAPI dose escalation therapy
Frequency of dose-limiting toxicities (DLT) of 177Lu-DOTA-FAPI at escalating dose levels of 177Lu-DOTA-FAPI

Secondary Outcome Measures

Assessment of organ dosimetry of 177Lu-DOTA-FAPI
Assessment of organ dosimetry of 177Lu-DOTA-FAPI using SPECT/CT imaging at various timepoints

Full Information

First Posted
April 15, 2021
Last Updated
April 15, 2021
Sponsor
The First Affiliated Hospital of Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT04849247
Brief Title
68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)
Official Title
68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase I, first-in-human study to evaluate the safety and efficacy of the 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI theranostic pair in patients with various types of cancer (locally advanced or metastatic cancer).
Detailed Description
This is a Phase I, first-in-human study to evaluate the safety and efficacy of the 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI theranostic pair in patients with various types of cancer. PET imaging using 68Ga-DOTA-FAPI will be used to diagnose patients who are eligible for the 177Lu-DOTA-FAPI. The overall purpose of this study is to identify the dose limiting toxicity (DLT) and recommended phase 2 dose (RP2D) of 177Lu-DOTA-FAPI. A 3+3 study design in is proposed to identify the RP2D of 177Lu-DOTA-FAPI. An expansion group will receive the RP2D in order to obtain initial estimates of response and additional information on safety of 177Lu-DOTA-FAPI. The hypotheses of this phase I study are that a) 68Ga-DOTA-FAPI will detect lesions in patients with various types of locally advanced or metastatic cancer. b) the theranostic pair 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI will be safe and well tolerated c) we will be able to identify a Recommended Phase 2 Dose (RP2D) for 177Lu-DOTA-FAPI therapy to be used in subsequent Phase II trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
177Lu-DOTA-FAPI, 68Ga-DOTA-FAPI, Theranostic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This is a first-in-human 3 + 3 study design to identify dose limiting toxicity and recommended phase 2 dose Masking: None (Open Label)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
177Lu-DOTA-FAPI dose escalation therapy study
Arm Type
Experimental
Arm Description
Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. Patients with sufficient lesion uptake of 68Ga DOTA-FAPI PET/CT will be offered therapy. Escalating doses of 30-150 mCi of 177Lu-DOTA-FAPI will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.
Arm Title
Recommended Phase 2 dose 177Lu-DOTA-FAPI therapy study
Arm Type
Experimental
Arm Description
Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. 10 patients will be enrolled in the dose expansion cohort and received the highest dose achieved in the 177Lu-DOTA-FAPI dose escalation therapy study
Intervention Type
Drug
Intervention Name(s)
68Ga-DOTA-FAPI, 177Lu-DOTA-FAPI
Intervention Description
PET imaging using 68Ga-DOTA-FAPI will be used to diagnose patients who are eligible for treatment with the 177Lu-DOTA-FAPI.
Primary Outcome Measure Information:
Title
68Ga-DOTA-FAPI PET/CT imaging
Description
Assessment of 68Ga-DOTA-FAPI PET/CT imaging to detect lesions in patients with various types of cancer (locally advanced or metastatic cancer)
Time Frame
1 hours from time of injection
Title
[177Lu]Lu-DOTA-FAPI dose escalation therapy
Description
Frequency of dose-limiting toxicities (DLT) of 177Lu-DOTA-FAPI at escalating dose levels of 177Lu-DOTA-FAPI
Time Frame
60 days from time of injection
Secondary Outcome Measure Information:
Title
Assessment of organ dosimetry of 177Lu-DOTA-FAPI
Description
Assessment of organ dosimetry of 177Lu-DOTA-FAPI using SPECT/CT imaging at various timepoints
Time Frame
1-7 days from time of injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: [68Ga]Ga-DOTA-FAPI PET/CT Inclusion Criteria: (i) adult participants (aged 18 years or order); (ii) Confirmed presence of various types of locally advanced or metastatic cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis); (iii) Participant must have documented tumor progression during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment; (iv) participants who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. (v) Eastern Cooperative Oncology Group Performance Status ≤ 2; (vi) Participant must have completed prior therapy at least 1 month (washout period) prior to [68Ga]Ga DOTA-FAPI PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline; Hematologic parameters defined as: (i)Absolute neutrophil count (ANC) ≥ 1000 cells/mm3; (ii)Platelet count ≥ 100,000/mm3; (iii)Hemoglobin ≥ 8 g/dL; Blood chemistry levels defined as: (i) AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN); (ii) Total bilirubin ≤ 2 times ULN; (iii) Creatinine ≤ 2 times ULN; (iv) Anticipated life expectancy ≥ 6 months; (v) Able to remain motionless for up to 10-20 minutes per scan; [177Lu]Lu-DOTA-FAPI therapy Inclusion Criteria: (i) Completion of entry into [68Ga]Ga-DOTA-FAPI PET study and completion of scan; (ii) CThe presence of at least one measurable disease by [68Ga]Ga-DOTA-FAPI PET/CT (SUVmax > 10-fold above normal lung or liver); Exclusion Criteria: (i) 1.Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA); (ii)Participants with Class 3 or 4 NYHA Congestive Heart Failure (iii) Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding); (iv) Pregnant or lactating women; (v)Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks; (vi)Has an additional active malignancy requiring therapy within the past 2 years; (vii)Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy; (viii)Psychiatric illness/social situations that would interfere with compliance with study requirements; (ix)Cannot undergo PET/CT scanning because of weight limits (350 lbs); (x)INR>1.2; PTT>5 seconds above UNL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haojun Chen, PhD
Phone
18659285282
Email
leochen0821@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Wu, PhD
Phone
13559216164
Email
13559216164@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Sun, PhD
Organizational Affiliation
The First Affiliated Hospital of Xiamen University
Official's Role
Study Chair
Facility Information:
Facility Name
First affiliated hospital of xiamen university
City
XiaMen
State/Province
Fujian
ZIP/Postal Code
0086-361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long Sun, doctor
Phone
86 0592-2137077
Email
13178352662@163.com

12. IPD Sharing Statement

Learn more about this trial

68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)

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