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

NCT04849247 | Unknown Phase 1

• 1 other identifier: XMYYL2021KYSB082
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

  1 hours from time of injection

• [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

  60 days from time of injection

Secondary Outcomes (1)

• Assessment of organ dosimetry of 177Lu-DOTA-FAPI

  1-7 days from time of injection

Study Arms (2)

177Lu-DOTA-FAPI dose escalation therapy study

EXPERIMENTAL

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.

Drug: 68Ga-DOTA-FAPI, 177Lu-DOTA-FAPI

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

EXPERIMENTAL

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

Drug: 68Ga-DOTA-FAPI, 177Lu-DOTA-FAPI

Interventions

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

PET imaging using 68Ga-DOTA-FAPI will be used to diagnose patients who are eligible for treatment with the 177Lu-DOTA-FAPI.

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• (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

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

First affiliated hospital of xiamen university

Xiamen, Fujian, 0086-361000, China

RECRUITING

Study Officials

• Long Sun, PhD

  The First Affiliated Hospital of Xiamen University

  STUDY CHAIR

Central Study Contacts

Haojun Chen, PhD

CONTACT

18659285282; leochen0821@foxmail.com

Hua Wu, PhD

CONTACT

13559216164; 13559216164@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a first-in-human 3 + 3 study design to identify dose limiting toxicity and recommended phase 2 dose Masking: None (Open Label)

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 19, 2021
• Study Start: April 13, 2021
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

CN (1)