TerminatedPhase 1

Safety Study of SEA-CD40 in Cancer Patients

Stopped: Study closed due to portfolio prioritization

United States159 participantsStarted 2015-02-28

Plain-language summary

This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
✕. Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative radiotherapy (to non-CNS disease) within 1 week
✕. Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
✕. Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
✕. Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
✕. History of radiation pneumonitis
✕. Neuropathy Grade 2 or higher
✕. Has received prior therapy with an anti-PD-1, anti-PDL1, or anti-PD-L2 agent, with an agent directed to another stimulatory or co-inhibitory T-cell receptor

What they're measuring

Incidence of adverse events (Parts A-K)

Timeframe: Through 6 weeks following last dose, up to an average of 6 months

Incidence of laboratory abnormalities (Parts A-K)

Timeframe: Through 6 weeks following last dose, up to an average of 6 months

Objective response rate (ORR) per RECIST according to investigator assessment in the efficacy-evaluable population (Part L)

Timeframe: Through 6 weeks following last dose, up to an average of 6 months

Trial details

NCT IDNCT02376699

SponsorSeagen Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-06

View on ClinicalTrials.gov More Carcinoma, Non-Small-Cell Lung trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
✕. Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative radiotherapy (to non-CNS disease) within 1 week
✕. Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
✕. Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
✕. Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
✕. History of radiation pneumonitis
✕. Neuropathy Grade 2 or higher
✕. Has received prior therapy with an anti-PD-1, anti-PDL1, or anti-PD-L2 agent, with an agent directed to another stimulatory or co-inhibitory T-cell receptor

What they're measuring

Incidence of adverse events (Parts A-K)

Timeframe: Through 6 weeks following last dose, up to an average of 6 months

Incidence of laboratory abnormalities (Parts A-K)

Timeframe: Through 6 weeks following last dose, up to an average of 6 months

Objective response rate (ORR) per RECIST according to investigator assessment in the efficacy-evaluable population (Part L)

Timeframe: Through 6 weeks following last dose, up to an average of 6 months