A Study to Evaluate the Safety and Pharmacology of DNIB06... | NCT01995188

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Escalation Cohort: DNIB0600A+Carboplatin	Experimental	DNIB0600A at an initial dose of 1.2 milligrams per kilogram (mg/kg) will be administered via intravenous (IV) infusion further following a dose-escalation until DLT under consultation of the investigator in combination with Carboplatin fixed dose of area under the curve (AUC)=6 mg/milliliter(mL)*minute (min) administered by IV infusion on Day 1 of a 21-day cycle.	Drug: Carboplatin Drug: DNIB0600A
NSCLC Dose Expansion Cohort: DNIB0600A+Carboplatin	Experimental	Recommended phase 2 dose (RP2D) of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL*min administered via IV infusion on Day 1 of each 21-day cycle in participants with NSCLC until disease progression or death, whichever occurs first.	Drug: DNIB0600A
PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin	Experimental	RP2D of DNIB0600A administered via IV infusion in combination with AUC=6 mg/mL*min administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first.	Drug: Carboplatin Drug: DNIB0600A
PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin+Bevacizumab	Experimental	RP2D of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL*min and Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle until disease progression or death, whichever occurs first.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Dose-limiting Toxicities (DLTs)		21 days
Number of Participants with Adverse events (AE) and Serious Adverse Events (SAEs)		Day 1 until 30 days after the last-infusion (up to approximately 3 years)
Number of Participants with Anti-DNIB0600A Antibodies		Pre-infusion (0 hour) at Day 1 of Cycle 1, 2, 3, 4 (each cycle of 21 days), 30 days after last infusion (up to approximately 3 years)

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of DNIB0600A		Pre-infusion (0 hour), hour 0.5,1 post-infusion Cycle 1 (each cycle= 28 days); 7, 14 days post-infusion of Cycle 1 (Day 8, 15 respectively); Day 1 of Cycle 2 and subsequent cycles up to last dose; 30 days after last dose (up to approximately 3 years)
Maximum Observed Plasma Concentration (Cmax)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive.
PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
Female participants of childbearing potential must use effective contraception as defined by study protocol and cannot be pregnant or breastfeeding.

NSCLC-specific Inclusion Criteria:

Histological documentation of incurable, locally advanced, or metastatic non-squamous
NSCLC that has progressed on prior treatment
Not more than 2 prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within 6 months of recurrence is considered a treatment regimen in the metastatic setting).
For participants with a documented epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement, one additional line of non-cytotoxic prior treatment will be permitted provided the therapy is a targeted agent against the EGFR mutation or ALK rearrangement.
For participants with lung cancer, centrally confirmed high expression of a sodium-dependent phosphate transporter (NaPi2b) by immunohistochemistry (IHC) is required (i.e., IHC 2+ or 3+).

Exclusion Criteria:

Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1.
For ovarian cancer participants only, platinum-based chemotherapy within 6 months prior to Day 1.
For ovarian cancer participants only, platinum treatment with more than two platinum-based chemotherapy regiments or more than four anti-cancer regimens, overall, for the treatment of ovarian cancer.
Palliative radiation within 2 weeks prior to Day 1.
Toxicity (except alopecia and anorexia) from prior therapy or neuropathy of grades > 1.
Evidence of any significant disease or condition that could affect compliance with the protocol or interpretation of results.
Known active infection (except fungal nail infections).
History of liver disease or human immunodeficiency virus (HIV).
Other malignancy within the last 5 years, except for adequately treated or controlled carcinoma in situ of the cervix or skin cancer or primary endometrial cancer of stage \

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital.		Boston	Massachusetts	02114	United States
Dana Farber Cancer Inst.

ID	Term
D000068258	Bevacizumab
D016190	Carboplatin
C000654806	lifastuzumab vedotin

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D056831	Coordination Complexes
D009930	Organic Chemicals