A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• Carboplatin — DRUG
  Carboplatin fixed dose of AUC=6 mg/mL\*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first.
• DNIB0600A — DRUG
  DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.

Study Details

This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab \[Avastin\] in three dose expansion cohorts.

Key Dates

First listed

Nov 26, 2013

Start date

Dec 16, 2013

Status verified

Oct 2017

Primary completion

Nov 9, 2016

Completion

Nov 9, 2016

Study Design

Enrollment

41 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation Cohort: DNIB0600A+Carboplatin
  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.
• Experimental: NSCLC Dose Expansion Cohort: DNIB0600A+Carboplatin
  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.
• Experimental: PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin
  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.
• Experimental: PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin+Bevacizumab
  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.

Primary Outcome Measure

Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Locations (4)

Find similar trials in Boston, MA

Related Studies

• A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
  PHASE3 · Recruiting · AstraZeneca · Mobile, Alabama
• A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
  PHASE2/PHASE3 · Recruiting · AbbVie · Chandler, Arizona