NCT02837991

Brief Summary

This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2016

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
Last Updated

June 4, 2020

Status Verified

November 1, 2018

Enrollment Period

2.5 years

First QC Date

July 13, 2016

Last Update Submit

June 2, 2020

Conditions

Renal Cell Carcinoma (RCC)Clear-cell Renal Cell CarcinomaPapillary Renal Cell CarcinomaKidney NeoplasmsMetastatic Renal Cell CarcinomaOvarian Clear Cell Carcinoma

Keywords

Kidney CancerCelldexDose EscalationOvarian CancerOvarian CarcinomaKidney Diseases

Outcome Measures

Primary Outcomes (2)

  • Dose Escalation - Determine Maximum Tolerated Dose (MTD)

    Determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of CDX-014 (in mg/kg). MTD will be defined as the highest dose-level where DLT (dose-limiting toxicity) occurs in less than 33% of treated patients.

    Within 21 days after first dose.

  • Cohort Expansion - Assess Objective Response Rate (ORR)

    Objective Response Rate (ORR) defined as the proportion of patients who achieve radiographic partial or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.

    Evaluated every 6-9 weeks following treatment initiation until treatment is discontinued or disease progression, up to 5 years.

Study Arms (1)

CDX-014

EXPERIMENTAL

During the treatment phase of the study, patients will receive CDX-014 treatment every 3 weeks (RCC or OCCC) or every 2 weeks (RCC) as long as they remain eligible. Patients may be discontinued from CDX-014 treatment based on the results of disease assessments or if experiencing side effects that make study therapy intolerable. The planned dose of CDX-014 depends on the cohort assigned at enrollment.

Drug: CDX-014

Interventions

CDX-014DRUG
CDX-014

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary renal cell carcinoma or histologically confirmed clear cell ovarian carcinoma.
  • For RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies. For OCCC, at least one line of prior therapy with a platinum and taxane regimen.
  • Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
  • Measureable (target) disease.
  • Must have available tumor tissue for TIM-1 expression testing
  • Life expectancy ≥ 3 months
  • If of childbearing potential (male or female), agrees to use effective contraception during study treatment and for at least 6 months following last treatment dose.

You may not qualify if:

  • Prior therapy containing MMAE
  • Any prior cytotoxic chemotherapy regimen, including antibody drug conjugates for RCC or cytotoxic chemotherapy within 3 weeks of study treatment for OCCC
  • Tyrosine kinase inhibitor (TKI) therapy within 2 weeks or at least 5 half-lives (whichever is longer) prior to planned start of study treatment.
  • Monoclonal antibody therapy within 4 weeks prior to the planned start of study treatment.
  • Radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
  • Major surgery or significant traumatic injury within 4 weeks prior to study entry.
  • Use of other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study treatment.
  • Concurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes or infection), known infection with HIV, Hepatitis B or Hepatitis C.
  • Brain metastases, unless previously treated and asymptomatic and not progressive for 2 months.
  • Significant cardiovascular disease (including congestive heart failure).
  • Other malignancy except for treated and cured basal or squamous cell skin cancer, cured in situ cancers, or other cancer from which the patient has been disease-free for ≥ 3 years.
  • Chronic use of systemic corticosteroid above an accepted physiologic dose (5mg per day of prednisone or equivalent) within 7 days of enrollment except when used as premedication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • McGregor BA, Gordon M, Flippot R, Agarwal N, George S, Quinn DI, Rogalski M, Hawthorne T, Keler T, Choueiri TK. Safety and efficacy of CDX-014, an antibody-drug conjugate directed against T cell immunoglobulin mucin-1 in advanced renal cell carcinoma. Invest New Drugs. 2020 Dec;38(6):1807-1814. doi: 10.1007/s10637-020-00945-y. Epub 2020 May 29.

    PMID: 32472319RESULT

MeSH Terms

Conditions

Carcinoma, Renal CellKidney NeoplasmsOvarian NeoplasmsKidney Diseases

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrologic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 20, 2016

Study Start

June 1, 2016

Primary Completion

November 16, 2018

Study Completion

November 16, 2018

Last Updated

June 4, 2020

Record last verified: 2018-11

Locations

US(5)