Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

Experimental: Arm 1A

T-DXd and 5-fluorouracil (5-FU)

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Experimental: Arm 1B

T-DXd and capecitabine

Drug: Capecitabine

Capecitabine: administered orally

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Experimental: Arm 1C

T-DXd and durvalumab

Biological: Durvalumab

Durvalumab: administered as an IV infusion

Other Name: MEDI4736

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Experimental: Arm 1D(b)

T-DXd, capecitabine, and oxaliplatin

Drug: Capecitabine

Capecitabine: administered orally

Drug: Oxaliplatin

Oxaliplatin: administered as an IV infusion

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Experimental: Arm 1E(a)

T-DXd, 5-FU, and durvalumab

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Biological: Durvalumab

Durvalumab: administered as an IV infusion

Other Name: MEDI4736

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Experimental: Arm 1E(b)

T-DXd, capecitabine, and durvalumab

Drug: Capecitabine

Capecitabine: administered orally

Biological: Durvalumab

Durvalumab: administered as an IV infusion

Other Name: MEDI4736

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Active Comparator: Arm 2A

Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Drug: Capecitabine

Capecitabine: administered orally

Drug: Oxaliplatin

Oxaliplatin: administered as an IV infusion

Biological: Trastuzumab

Trastuzumab: administered as an IV infusion

Drug: Cisplatin

Cisplatin: administered as an IV infusion

Experimental: Arm 2B

T-DXd monotherapy

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Experimental: Arm 2C

T-DXd, 5-FU or capecitabine

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Drug: Capecitabine

Capecitabine: administered orally

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Experimental: Arm 2D

T-DXd, 5-FU or capecitabine, and pembrolizumab

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Drug: Capecitabine

Capecitabine: administered orally

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Biological: Pembrolizumab

Pembrolizumab: administered as an IV infusion

Experimental: Arm 2E

T-DXd and pembrolizumab

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Biological: Pembrolizumab

Pembrolizumab: administered as an IV infusion

Experimental: Arm 2F

T-DXd, chemotherapy (FP) and pembrolizumab

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Drug: Capecitabine

Capecitabine: administered orally

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Biological: Pembrolizumab

Pembrolizumab: administered as an IV infusion

Experimental: Arm 3A

T-DXd, FP and BSP (MEDI5752)

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Drug: Capecitabine

Capecitabine: administered orally

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Biological: MEDI5752

MEDI5752: administered as an IV infusion

Experimental: Arm 3B

T-DXd, FP and BSP (MEDI5752)

Drug: Fluorouracil (5-FU)

5-FU: administered as an IV infusion

Drug: Capecitabine

Capecitabine: administered orally

Drug: Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

Other Name: DS-8201a

Biological: MEDI5752

MEDI5752: administered as an IV infusion

Source: View full study details on ClinicalTrials.gov

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