Back to Trials
NCT04379596PHASE2Recruiting

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

AstraZeneca

Start Date

6/3/2020

Completion Date

6/1/2027

Summary

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

Eligibility Criteria

Age Range: 18 years to 130 years

Inclusion criteria: 1. Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations 2. Disease Characteristics: 1. Locally advanced, unresectable, or metastatic disease based on most recent imaging 2. For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results 3. For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results 3. For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3, Part 4 and Part 5, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3 \[Arm 3A\] and Part 4 \[Arm 4A\]) or HER2-low (Part 3 \[Arm 3B\], Part 4 \[Arm 4B\] and Part 5)) status 4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1 5. Has protocol defined adequate bone marrow and organ function including cardiac, renal and hepatic function 6. If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study. Exclusion criteria: 1. Part 1 to 4: History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection. Part 5: evidence of active, uncontroled HIV, HBV or HCV infection. 2. Uncontrolled intercurrent illness. 3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening. 4. Lung-specific intercurrent clinically significant severe illnesses. 5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. 6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). 7. Has spinal cord compression or clinically active central nervous system metastases.

Interventions

DRUG

Fluorouracil (5-FU)

DRUG

Capecitabine

BIOLOGICAL

Durvalumab

DRUG

Oxaliplatin

BIOLOGICAL

Trastuzumab

DRUG

Trastuzumab deruxtecan

DRUG

Cisplatin

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Volrustomig

BIOLOGICAL

Rilvegostomig

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Gastric Cancer

Locations

Research Site

Santa Monica, California 90404

United States

Research Site

Westwood, Kansas 66205

United States

Research Site

Baltimore, Maryland 21287

United States

Research Site

Boston, Massachusetts 02114

United States

Research Site

Boston, Massachusetts 02215

United States

Research Site

Ann Arbor, Michigan 48109

United States

Research Site

New York, New York 10065

United States

Research Site

Durham, North Carolina 27710

United States

Research Site

Houston, Texas 77090

United States

Research Site

Fairfax, Virginia 22031

United States

Research Site

Florianópolis, 88020-210

Brazil

Research Site

Londrina, 86015-520

Brazil

Research Site

Natal, 59075-740

Brazil

Research Site

Porto Alegre, 90160-093

Brazil

Research Site

Ribeirão Preto, 14051-140

Brazil

Research Site

Rio de Janeiro, 22793-080

Brazil

Research Site

Santa Maria, 97015-450

Brazil

Research Site

São Jose Do Rio Preto, 15090-000

Brazil

Research Site

São Paulo, 01509-900

Brazil

Research Site

São Paulo, 03102-002

Brazil

Research Site

São Paulo, 045202-001

Brazil

Research Site

Edmonton, Alberta T6G 1Z2

Canada

Research Site

Ottawa, Ontario K1H 8L6

Canada

Research Site

Toronto, Ontario M4N 3M5

Canada

Research Site

Toronto, Ontario M5G 2M9

Canada

Research Site

Montreal, Quebec H4A 3J1

Canada

Research Site

Québec, Quebec G1J 1Z4

Canada

Research Site

Chengdu, 610042

China

Research Site

Guangzhou, 510062

China

Research Site

Guiyang, 550002

China

Research Site

Hangzhou, 310022

China

Research Site

Hefei, 230001

China

Research Site

Hefei, 230601

China

Research Site

Shanghai, 200025

China

Research Site

Shanghai, 200031

China

Research Site

Shanghai, 200032

China

Research Site

Shanghai, 200050

China

Research Site

Shenyang, 110001

China

Research Site

Ürümqi, 830000

China

Research Site

Wuhan, 430000

China

Research Site

Xiamen, 361003

China

Research Site

Zhengzhou, 450008

China

Research Site

Frankfurt, 60488

Germany

Research Site

Frankfurt, 60590

Germany

Research Site

Hamburg, 20249

Germany

Research Site

Leipzig, 04103

Germany

Research Site

Mannheim, 68167

Germany

Research Site

München, 81675

Germany

Research Site

Milan, 20133

Italy

Research Site

Milan, 20162

Italy

Research Site

Naples, 80131

Italy

Research Site

Padova, 35128

Italy

Research Site

Roma, 00168

Italy

Research Site

Verona, 37134

Italy

Research Site

Chūōku, 104-0045

Japan

Research Site

Kashiwa, 277-8577

Japan

Research Site

Kita-gun, 761-0793

Japan

Research Site

Ota-shi, 373-8550

Japan

Research Site

Amsterdam, 1066CX

Netherlands

Research Site

Amsterdam, 1081 HV

Netherlands

Research Site

Utrecht, 3584CG

Netherlands

Research Site

Gdansk, 80-214

Poland

Research Site

Konin, 62-500

Poland

Research Site

Koszalin, 75-581

Poland

Research Site

Krakow, 31-501

Poland

Research Site

Lublin, 20-090

Poland

Research Site

Opole, 45-061

Poland

Research Site

Tomaszów Mazowiecki, 97-200

Poland

Research Site

Warsaw, 02-034

Poland

Research Site

Kostroma, 156005

Russia

Research Site

Moscow, 115478

Russia

Research Site

Moscow, 125284

Russia

Research Site

Moscow, 143423

Russia

Research Site

Moscow, 143442

Russia

Research Site

Novosibirsk, 630099

Russia

Research Site

Saint Petersburg, 195271

Russia

Research Site

Saint Petersburg, 196603

Russia

Research Site

Saint Petersburg, 197022

Russia

Research Site

Saint Petersburg, 197758

Russia

Research Site

Seongnam-si, 13620

South Korea

Research Site

Seoul, 03080

South Korea

Research Site

Seoul, 03722

South Korea

Research Site

Seoul, 05505

South Korea

Research Site

Seoul, 06351

South Korea

Research Site

Barcelona, 08035

Spain

Research Site

Madrid, 28007

Spain

Research Site

Madrid, 28034

Spain

Research Site

Santander, 39008

Spain

Research Site

Seville, 41013

Spain

Research Site

Kaohsiung City, 80756

Taiwan

Research Site

Kaohsiung City, 83301

Taiwan

Research Site

Tainan, 704

Taiwan

Research Site

Taipei, 10002

Taiwan

Research Site

Taipei, 11217

Taiwan

Research Site

Taoyuan, 333

Taiwan

Research Site

Cambridge, CB2 0QQ

United Kingdom

Research Site

Dundee, DD1 9SY

United Kingdom

Research Site

London, NW1 2PG

United Kingdom

Research Site

Manchester, M20 4BX

United Kingdom

Research Site

Sutton, SM2 5PT

United Kingdom