First in Man Study Investigating the Biodistribution, the Safety and Optimal Recommended Dose of a New Radiolabelled Monoclonal Antibody Targeting Frizzled Homolog 10

NCT01469975 | Terminated Phase 1 DMC

• 3 other identifiers: SYNFRIZZ2011-002574-23ET11-062
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Advanced synovial sarcoma represents an unmet medical need. The gene encoding frizzled homologue 10 (FZD10), a 7-transmenbrane receptor, member of the Wnt signalling receptor family, is overexpressed in SS and is undetectable in normal human tissues except placenta. OncoTherapy Science Inc. has developed a chimeric humanized monoclonal antibody (mAb) against FZD10, named OTSA101. Non-radiolabeled OTSA101 antibody has only weak antagonistic activity on SS cell growth. However, Yttrium 90-radiolabeled OTSA101 (OTSA101-DTPA-90Y) showed significant antitumor activity following a single intravenous injection in mouse xenograft model. This first in man clinical trial (Phase I) in relapsing SS patients resistant to Doxorubicin and ifosfamide will be divided in 2 parts. In Part 1 (imaging part using OTSA101 radiolabelled with Indium 111 \[111In\]), the biodistribution and tumor uptake of OTSA101-DTPA-111In will be followed using 111In as radiotracer. In Part 2 (therapeutic part with OTSA101 radiolabelled with Yttrium 90 \[90Y\]), the safety and PK profiles of OTSA101-DTPA-90Y will be determined and preliminary efficacy data will be collected. This first in Man study should allow defining the optimal recommended dose of OTSA101-DTPA-90Y. Patients will be followed during 1 year.

Conditions

Sarcoma, Synovial

Keywords

cancer; relapse or refractory

Outcome Measures

Primary Outcomes (2)

• Part 1: Biodistribution and binding of OTSA101-DTPA-111In

  Limiting Event is defined as unacceptable/unexpected biodistribution/binding of the mAb, and/or absence of tumor uptake. Data review will be performed on a patient per patient basis. The Biodistribution and binding of OTSA101-DTPA-111In will be analyzed. The rate of Limiting Event will be summarized by a proportion together with its 95% confidence interval.

  144 hours post-dose (dose administered at day -14)

• Part 2: Safety profile

  The safety profile will be summarized with descriptive statistics including the following: * Occurrence of Severe Toxicities during the first 8 weeks post-injection of OTSA101-DTPA-90Y. * Occurrence of adverse events and serious adverse events during the study treatment period, including laboratory abnormalities, according to CTCAE v4.0 criteria. * Optimal recommended dose, defined as the dose level of OTSA101-DTPA-90Y with the best benefice-risk ratio taking into account the preliminary efficacy and safety data.

  During 1 year after randomization (day 0)

Secondary Outcomes (6)

• Part 1: Pharmacokinetics parameters

  They will be collected before the injection, (day -14) at 1, 2, 5, 24, 48, 72, 144 hours post dose and 7 days before randomisation

• Part 1: Safety profile of OTSA101-DTPA-111In

  During 14 days

• Part 2: Overall response rate

  At 6 and 12 weeks after treatment

• Part 2: Clinical benefit

  At 6 and 12 weeks after treatment

• Part 2: Duration of response

  At Week 6; Week12; Month 6; Month 9 and Month12 post Yttrium injection

Study Arms (3)

Arm A: Dose level 1

EXPERIMENTAL

1.5 mg of OTSA101-DTPA radiolabelled with 370MBq of 90Y

Drug: OTSA101-DTPA-90Y level 1

Arm B: Dose level 2

EXPERIMENTAL

1.5 mg of OTSA101-DTPA radiolabelled with 1110 MBq of 90Y

Drug: OTSA101-DTPA-90Y level 2

Arm C: Dose level 3

EXPERIMENTAL

3 mg of OTSA101-DTPA radiolabelled with 2220 MBq of 90Y

Drug: OTSA101-DTPA-90Y level 3

Interventions

OTSA101-DTPA-90Y level 1 DRUG

Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 370MBq of 90Y will be administered IV as a single injection on Day 0.

Arm A: Dose level 1

OTSA101-DTPA-90Y level 2 DRUG

Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 1110 MBq of 90Y will be administered IV as a single injection on Day 0.

Arm B: Dose level 2

OTSA101-DTPA-90Y level 3 DRUG

Part 2 of the study 3 mg of OTSA101-DTPA radiolabelled with 2220 MBq of 90Y will be administered IV as a single injection on Day 0. This third dose level evaluation will be based on safety and preliminary efficacy data.

Arm C: Dose level 3

Eligibility Criteria

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

You may qualify if:

• Male or female patients, age ≥ 18 years.
• Frozen or paraffin-embedded tumor samples for immunohistochemical analysis are mandatory for registration in this study.
• Patients with doxorubicin- and ifosfamide-resistant synovial sarcoma (defined as patients with progression under doxorubicin and ifosfamide treatments or with rapid progression (i.e. within 4 months) after the last dose of doxorubicin and ifosfamide, or patients previously treated with doxorubicin and ifosfamide and with disease progression on another regimen of chemotherapy for advanced disease).
• Patients must have disease not amenable to surgery, radiation or combined modality treatment with curative intent.
• At least one measurable site of disease as defined by RECIST criteria 1.1.
• ECOG performance status of 0, 1, 2.
• Life expectancy ≥ 3 months.
• Left Ventricular Ejection Fraction (LVEF)\> 50% as assessed by MUGA scan or ECHO at screening.
• Normal pulmonary function with Force Vital Capacity (FVC) of at least 60% and DLCO of at least 50%.
• Adequate bone marrow, liver and renal function including the following:
• Absolute neutrophil count ≥ 1.5 G/L, platelet count ≥ 100 G/L, and hemoglobin ≥ 10 g/dL)
• AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) and total bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN if liver metastases),
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min according to Cockroft formula.
• Adequate contraceptive methods for the whole duration of the study and for up to 12 months after the last study drug administration.
• Mandatory affiliation with a health insurance company.

You may not qualify if:

• Positive human anti-mouse antibody (HAMA) or human anti-chimeric antibody (HACA) response. HAMA/HACA assays will be performed only for patients previously treated by monoclonal antibodies.
• Uncontrolled arterial hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg or both despite appropriate therapy.
• Patients with brain metastases.
• Previous history of high-dose chemotherapy with stem cell rescue.
• Chronic use of immunosuppressive drugs such as systemic corticosteroids.
• Previous therapy with monoclonal antibodies within 4 months before study entry.
• Prior history of other malignancies other than synovial sarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years.
• No resolution of all specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to Grade ≤ 1 according to the NCI CTCAE v4.
• Known immediate or delayed hypersensitivity reaction to 111In, 90Y, DTPA or any excipients of the investigational product.
• Psychological, familial, sociological, or geographical conditions that would limit compliance with study protocol requirements.
• Pregnant and breastfeeding women are ineligible.

Sponsors & Collaborators

• Centre Leon Berard: lead
• OncoTherapy Science, Inc.: collaborator

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

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MeSH Terms

Conditions

Sarcoma, Synovial; Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Yves BLAY, MD, PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 10, 2011
• Study Start: December 1, 2011
• Primary Completion: February 3, 2015
• Study Completion: June 30, 2015
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

FR (1)