CompletedPhase 1

Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC

United States27 participantsStarted 2013-06-19

Plain-language summary

This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety, tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify the maximum tolerated dose (MTD) when MORAb-066 is administered IV once weekly on a 28-day cycle.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically confirmed diagnosis of breast, colorectal, pancreas, or NSCLC (adenocarcinoma) that is metastatic or unresectable for which there is no effective therapy.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 (see Appendix A).
✓. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓. Subject has recovered (to Grade less than or equal to 1) from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions (described separately below).
✓. Adequate organ system function less than or equal to 2 weeks prior to Day1, defined as follows:
✓. Life expectancy of greater than or equal to 12 weeks.
✓. Female patients of child-bearing potential (see Appendix C), and all male patients must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after their last MORAb-066 administration. A barrier method of contraception must be included.
✓. Patients must be greater than or equal to 18 years of age.

Exclusion criteria

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)

Trial details

NCT IDNCT01761240

SponsorMorphotek

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02-09

Results submitted2022-10-25

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