Know Cancer

or
forgot password

Prospective Multicentric Optimization and Phase I/II Study of Pretargeted Radioimmunotherapy (PRAIT) Using Anti-CEA x Anti-HSG TF2 Bispecific Antibody (bsMAb) and 177Lu-IMP-288 Peptide in Patients With CEA-expressing Small Cell Lung Carcinoma (SCLC)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

Thank you

Trial Information

Prospective Multicentric Optimization and Phase I/II Study of Pretargeted Radioimmunotherapy (PRAIT) Using Anti-CEA x Anti-HSG TF2 Bispecific Antibody (bsMAb) and 177Lu-IMP-288 Peptide in Patients With CEA-expressing Small Cell Lung Carcinoma (SCLC)


The purpose of this open-label prospective optimization and phase I/II clinical trial is to
examine the safety, optimal dose, targeting, dosimetry and efficacy of PRAIT using the
humanized anti-CEA x anti-HSG bsMAb TF2 and the 177Lu-IMP-288 peptide pretargeted in
patients with CEA-positive SCLC.

This study has 2 parts: Study plan I (Optimization study) and Study plan II (Escalating
activity phase I/II study).

The Study plan I is designed to optimize the pretargeting procedure using blood
pharmacokinetics (Pk) and dosimetry in 9 patients receiving escalating doses of TF2 followed
2 to 4 days later by 1.1 GBq/m2 of 177Lu-IMP-288.

The study plan II is designed to determined MTD of 177Lu-IMP-288 using dosimetry and
toxicity data in a phase I/II study performed in patients receiving optimal dose of TF2
bsMAb (determined in study plan I) followed 2 to 4 days by escalating activity of
177Lu-IMP-288.

A pre-therapy imaging study (using TF2 followed 2 to 4 days later by 185 MBq of
111In-IMP-288) is performed in the two study plans to qualify a patient for treatment with
the subsequent therapy dose.


Inclusion Criteria:



- Patients with histologic diagnosis of SCLC who are in partial response or who have
failed at least two lines of standard radiation and/or chemotherapy. Outside formal
contra-indication, patients must have received at least one prior platinum-based
chemotherapy

- Age ≥ 18 years

- At least 4-weeks after the previous treatment and have recovered from previous radio-
or chemotherapy

- Women of child-bearing potential must have a negative pregnancy test.

- Karnofsky performance status ≥ 70 or ECOG performance status 0-1

- Minimum life expectancy of 3 months

- Positive CEA on immunohistology or plasma CEA ≥ 10 ng/mL

- At least one measurable lesion by CT

- At least one abnormal focus by FDG-PET

- Imaging studies must be performed within 1-4 weeks before PRAIT study to document
extent of disease

- Signed informed consent form.

- Pregnant or lactating woman. Women of child-bearing potential will be asked to
practice adequate means of birth control for a minimum of 12 months after treatment.

- Male patient refusing effective contraception for a minimum of 12 months after
treatment.

- Brain metastases

- Known HIV or hepatitis

- Any serious active disease or co-morbid medical condition (according to the
investigator's decision and information provided in the IDB)

- Severe disorders of hemostasis or anticoagulant treatment cure

- Extensive irradiation to more than 25% of their red marrow

- Bone marrow involvement to more than 25%

- External radiation to specific organs or areas at the maximum toletared level

- Febrile aplasia during a previous chemotherapy

- Neutrophils < 1.5 G/l

- Platelets < 100 G/l

- Uncontrolled diabetes

- Poor renal function (creatinin level > 2.5 maximum normal level)

- Poor hepatic function (total bilirubin level > 30 mmol/l, transaminases > 2.5 maximum
normal level)

- Treatment with any investigational drug within 30 days before planned PRAIT and
during the study

- Any history of cancer during the last 5 years, with the exception of non-melanoma
skin tumors or stage 0 (in situ) cervical carcinoma,

- Presence of anti-antibody reactivity

- Known hypersensitivity to murine antibodies or proteins

- Adult patient unable to give informed consent because of intellectual impairment.

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288.

Safety Issue:

Yes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 08/9-O

NCT ID:

NCT01221675

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Radio Immunotherapy
  • Lutetium
  • patient ≥ 18 years of age with CEA-positive SCLC who are in partial response or who failed at least two lines of standard radiation and/or chemotherapy
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location