CompletedPhase 1

Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies

United States, Canada48 participantsStarted 2020-11-19

Plain-language summary

The primary purpose of this study is to see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumor malignancies.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Squamous cell carcinoma of the head and neck
✓. Non-small-cell lung carcinoma-adenocarcinoma histology subtype
✓. Pancreatic ductal adenocarcinoma
✓. Cholangiocarcinoma
✓. Colorectal carcinoma (microsatellite stable \[MSS\] and microsatellite instability-high \[MSI-H\] phenotypes)
✓. Gastric carcinoma (includes gastroesophageal carcinoma)
✓. Esophageal carcinoma (includes squamous cell and adenocarcinoma)
✓. Mesothelioma (pleural and peritoneal)

What they're measuring

Part I: To evaluate the incidence, severity and relationship of (S)AEs to establish the MTD/MAD of Sym024 monotherapy.

Timeframe: 28 days

Part II: To evaluate the incidence, severity and relationship of (S)AEs to establish MTD/MAD of Sym024 in combination with Sym021.

Timeframe: 28 days

Part III: To evaluate the incidence, severity and relationship of (S)AEs to further assess safety of Sym024 when administered alone or in combination with Sym021.

Timeframe: 12 months

Trial details

NCT IDNCT04672434

SponsorSymphogen A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-22

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