NCT06271837
Recruiting
Phase 2
A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) as Monotherapy or in Combination With Anti-cancer Agents for the Treatment of Patients With Selected HER2-expressing Tumors (DESTINY PanTumor03)
Overview
- Phase
- Phase 2
- Intervention
- Trastuzumab deruxtecan
- Conditions
- Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
- Sponsor
- AstraZeneca
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Confirmed Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2-expressing solid tumors which are not eligible for curative therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age.
- •Locally advanced, unresectable, or metastatic solid tumors based on most recent imaging.
- •HER2 expression.
- •ECOG performance status of 0-
- •Must provide an adequate FFPE tumor sample to centrally determine HER2 status and other correlatives.
- •Has measurable target disease assessed by the investigator based on RECIST 1.
- •Adequate organ function and bone marrow within 14 days before enrollment.
- •Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Capable of giving signed informed consent.
- •Provision of signed and dated written ICF prior to mandatory study-specific procedures, sampling, or analyses.
Exclusion Criteria
- •Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the gastric body or gastroesophageal junction.
- •Has substance abuse or any other medical conditions that may interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
- •A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and concentrated ascites reinfusion therapy.
- •History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
- •Has unresolved toxicities from previous anti cancer therapy.
- •Has any spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
- •Uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals, or active infection including tuberculosis.
- •Active primary immunodeficiency, known uncontrolled active HIV infection, or active Hepatitis B or C infection.
- •Protocol-defined inadequate cardiac function.
- •History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Arms & Interventions
Part 1
HER2 IHC 3+ solid tumors (excluding breast and gastric cancer)
Intervention: Trastuzumab deruxtecan
Part 2 Cohort A
HER2 IHC 2+ solid tumors (excluding breast and gastric cancer)
Intervention: Trastuzumab deruxtecan
Part 2 Cohort B
HER2 IHC 1+ gynecologic cancers
Intervention: Trastuzumab deruxtecan
Part 3
HER2 IHC 3+ or 2+ cervical cancer
Intervention: Trastuzumab deruxtecan
Part 3
HER2 IHC 3+ or 2+ cervical cancer
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Confirmed Objective Response Rate (ORR)
Time Frame: An average of approximately 12 months
Confirmed ORR is the proportion of patients who have a confirmed complete response or confirmed partial response per RECIST 1.1.
Secondary Outcomes
- Progression-free survival (PFS)(An average of approximately 12 months)
- Immunogenicity of T-DXd(An average of approximately 12 months)
- Duration of Response (DoR)(An average of approximately 12 months)
- Disease control rate (DCR)(An average of approximately 12 months)
- Overall survival (OS)(An average of approximately 12 months)
- Occurrence of adverse events (AEs) and serious adverse events (SAEs)(An average of approximately 12 months)
- Pharmacokinetics (PK) of T-DXd(An average of approximately 12 months)
- Confirmed best objective response (BOR)(An average of approximately 12 months)
Study Sites (1)
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