A Study of SAR428926 in Patients With Advanced Solid Tumors

NCT02575781 | Completed Phase 1

• 3 other identifiers: TED141472015-001441-92U1111-1168-4706
• Study Type: interventional
• Target: 34
• Locations: 3 countries
• Sites: 3

Brief Summary

Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors. To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926 Secondary Objectives: To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites. To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients. To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (3)

• Number of patients with dose limiting adverse events (Escalation cohort)

  4 weeks

• Number of patients with corneal adverse events impacting study treatment (Escalation cohort)

  8 weeks

• Assessment of overall response rate using standard imaging and RECIST v1.1 criteria (Expansion cohort)

  Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first

Secondary Outcomes (11)

• Number of treatment emergent adverse events

  Up to 3 years

• Assessment of PK parameter: maximum concentration (Cmax)

  2 months

• Assessment of PK parameter: time to reach maximum concentration (tmax)

  2 months

• Assessment of PK parameter: trough plasma concentration (Ctrough)

  Every 2 weeks until approximately 14 weeks

• Assessment of PK parameter: area under the plasma concentration curve versus time curve between 1 and 14 days (AUC0-14 day)

  2 months

Study Arms (3)

SAR428926-Escalating cohort

EXPERIMENTAL

SAR428926 will be administered intravenously up to disease progression or dose limiting toxicities

Drug: SAR428926

SAR428926 in triple negative breast cancer-Expansion Cohort 1

EXPERIMENTAL

SAR428926 will be administered intravenously at maximum tolerated dose (MTD) up to disease progression or unacceptable toxicity

Drug: SAR428926

SAR428926 in solid tumors-Expansion Cohort 2

EXPERIMENTAL

SAR428926 will be administered intravenously at the MTD up to disease progression or unacceptable toxicity

Drug: SAR428926

Interventions

SAR428926 DRUG

Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

SAR428926 in solid tumors-Expansion Cohort 2; SAR428926 in triple negative breast cancer-Expansion Cohort 1; SAR428926-Escalating cohort

Eligibility Criteria

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

You may qualify if:

• Patients with advanced solid tumor with no standard alternative treatment.
• Availability of archived tumor tissue for SAR428926 targeted antigen testing.
• For participants in the Escalation Phase: human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC), gastric cancer, colorectal cancer (CRC), ovarian cancer, prostate cancer and non small-cell lung cancer (NSCLC).
• For participants in the Expansion Phase: patients with TNBC, prostate cancer, CRC, ovarian cancer or NSCLC and positive SAR428926 targeted antigen.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and one lesion amenable to biopsy in expansion cohort only (except for NSCLC patients).

You may not qualify if:

• Age less than 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
• New or progressing brain metastases.
• Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies, including other experimental anticancer treatment, before first administration of SAR428926, or non resolution of toxicities induced by these anticancer therapies.
• Women of reproductive potential and male subjects with female partners of childbearing potential who are not willing to avoid pregnancy.
• Pregnancy or breast feeding.
• Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates \[ADCs\]).
• Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
• Significant concomitant illness, including psychiatric condition that, in the opinion of the Investigator or Sponsor, would adversely affect the patient's participation in the study.
• Any surgery within the preceding 3 weeks.
• Known human immunodeficiency virus (HIV) infection or active hepatitis B or C viral infection.
• Poor bone marrow reserve.
• Poor kidney and liver function.
• Previous history of chronic corneal diseases (even if asymptomatic) or unresolved acute non-recurrent corneal conditions. Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
• Unresolved signs and symptoms of peripheral neuropathy; Grade 1 is acceptable.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 2080001

København Ø, 2100, Denmark

Location

Investigational Site Number 2500001

Villejuif, 94805, France

Location

Investigational Site Number 7240001

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 15, 2015
• Study Start: October 5, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

FR (1); DK (1); ES (1)