Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer

Required: RAS wild-type

left-sided colorectal cancer with wild-type RAS/BRAF

Required: BRAF wild-type

left-sided colorectal cancer with wild-type RAS/BRAF

Required: HER2 negative or low expression (negative or low)

HER2-negative or low expression

Excluded: MMR deficient

Subjects with MSI-H or dMMR

Excluded: MSI high

Subjects with MSI-H or dMMR

Cannot have received: systemic chemotherapy

Exception: not previously received systemic chemotherapy (except for left-sided colorectal cancer with wild-type RAS/BRAF); or subjects who have progressed after first-line chemotherapy with or without targeted or immunotherapy

Subjects who have not previously received systemic chemotherapy (except for left-sided colorectal cancer with wild-type RAS/BRAF); or subjects who have progressed after first-line chemotherapy with or without targeted or immunotherapy

Cannot have received: systemic chemotherapy

Exception: for other GI tumors: not previously received systemic chemotherapy; for patients who previously received adjuvant chemotherapy, neoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease with curative intent, if disease progression occurs more than 6 months after the completion of the last treatment, they are eligible

Subjects who have not previously received systemic chemotherapy; for patients who previously received adjuvant chemotherapy, neoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease with curative intent, if disease progression occurs more than 6 months after the completion of the last treatment, they are eligible for this study

Cannot have received: systemic anti-tumor drugs or local anti-tumor therapy

Systemic treatment with anti-tumor drugs, or local anti-tumor therapy within 28 days before starting the study treatment

Cannot have received: local radiotherapy

Exception: palliative radiotherapy for bone metastasis completed more than 2 weeks before baseline tumor assessment is acceptable

Received local radiotherapy within 2 months prior to the first administration of investigational drug (palliative radiotherapy for bone metastasis completed more than 2 weeks before baseline tumor assessment is acceptable)

Cannot have received: non-specific immunomodulatory therapy (interleukins, interferons, thymosin, tumor necrosis factor)

Received non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to the first administration of investigational drug

Cannot have received: investigational drugs or investigational medical devices

Receipt of other investigational drugs or investigational medical devices within 28 days prior to the first administration of the investigational drug