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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphogen A/S

Criteria

Inclusion Criteria:

• Male or female patients, ≥18 years.

• Documented (histologically or cytologically proven), locally advanced or metastatic solid tumor malignancy (must be one of the following):

1. Squamous cell carcinoma of the head and neck

2. Non-small-cell lung carcinoma-adenocarcinoma histology subtype

3. Pancreatic ductal adenocarcinoma

4. Cholangiocarcinoma

5. Colorectal carcinoma (microsatellite stable [MSS] and microsatellite instability-high [MSI-H] phenotypes)

6. Gastric carcinoma (includes gastroesophageal carcinoma)

7. Esophageal carcinoma (includes squamous cell and adenocarcinoma)

8. Mesothelioma (pleural and peritoneal)

• Malignancy that is not currently amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.

• Measurable disease according to RECIST v1.1.

• Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.

• Agreeing to mandatory tumor tissue biopsies (2 total).

• ECOG PS of 0 or 1.

• Adequate organ function as indicated by the following laboratory values.

• Adequate contraception required as appropriate.

Exclusion Criteria:

• Central nervous system (CNS) malignancies.

• Clinically significant cardiovascular disease or condition.

• Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug(s).

• Active uncontrolled bleeding or a known bleeding diathesis.

• Significant ocular disease or condition.

• Significant pulmonary disease or condition.

• Current or recent (within 6 months) significant gastrointestinal disease or condition.

• Active, known or suspected autoimmune disease.

• History of organ transplantation (i.e., stem cell or solid organ transplant).

• Known history of human immunodeficiency virus (HIV) or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

• Any other serious/active/uncontrolled infection.

• History of significant toxicities associated with previous administration of immune checkpoint inhibitors.

• Known or suspected hypersensitivity to any of the excipients of formulated study drug.

• Unresolved >Grade 1 toxicity associated with any prior antineoplastic therapy.

• Inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the first dose of study drug(s).

• Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy).

Therapeutic Exclusions

• Prior therapy with Sym024 or other inhibitors of CD73, CD39 or adenosine receptors ADORA2A, ADORA2B.

• Part II and Part III, prior anti-PD-(L)1 therapy, except for indications where it is approved.

• Any antineoplastic agent for the primary malignancy (standard or investigational) within 4 weeks or 5 elimination half-lives.

• Any other investigational treatments within 2 weeks prior to the first dose of study drug(s).

• Radiotherapy, with exceptions.

• Live vaccines against infectious diseases 4 weeks prior to the first dose of study drug(s).

• Immunosuppressive or systemic glucocorticoids therapy (>10 mg daily prednisone or equivalent) within 2 weeks prior to the first dose of study drug(s), with exceptions.

• Prophylactic use of hematopoietic growth factors within 1 week prior to the first dose of study drug(s).