A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2 Overexpressing Gastric Cancer (DESTINY-Gastric03) (DG-03)

STATUS

Recruiting
End date

Oct 13, 2023
participants needed

255
sponsor

AstraZeneca

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Updated on 12 October 2022

See if I qualify

fluorouracil

metastasis

oxaliplatin

metastatic adenocarcinoma

capecitabine

pembrolizumab

HER2

trastuzumab

cancer chemotherapy

adenocarcinoma

erbb2

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-positive 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-positive 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.

Details

Condition	Gastric Cancer
Treatment	Capecitabine, cisplatin, Trastuzumab, Pembrolizumab, Oxaliplatin, durvalumab, Fluorouracil (5-Fu), Trastuzumab deruxtecan
Clinical Study Identifier	NCT04379596
Sponsor	AstraZeneca
Last Modified on	12 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Male and female participants must be at least 18 years of age
	Disease Characteristics
	Locally advanced, unresectable, or metastatic disease Pathologically
	documented adenocarcinoma of the stomach, GEJ or esophagus with HER2
	overexpression (IHC 3+ or IHC 2+/ISH+)
	For Part 1, progression on or after at least one prior trastuzumab containing Regimen
	For Part 2, previously untreated for unresectable or metastatic adenocarcinoma
	Has measurable target disease assessed by the Investigator based on RECIST version 1.1
	of the stomach, GEJ or esophagus with HER2 overexpression
	Has protocol defined adequate organ function including cardiac, renal and hepatic function
	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
	History of active primary immunodeficiency, known HIV, active HBV or HCV infection
	Uncontrolled intercurrent illness
	History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
	Lung-specific intercurrent clinically significant severe illnesses
	Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
	Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
	Has spinal cord compression or clinically active central nervous system metastases

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