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Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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AstraZeneca

Status and phase

Enrolling
Phase 2

Conditions

Endometrial Cancer
Gastric Cancer
Biliary Tract Cancer
Urothelial Cancer
Metastatic Castration-resistant Prostate Cancer
Ovarian Cancer
Colorectal Cancer

Treatments

Drug: Carboplatin
Drug: Leucovorin LV
Drug: Bevacizumab
Drug: Datopotamab deruxtecan (Dato-DXd)
Drug: Prednisone/ prednisolone
Drug: Saruparib
Drug: Durvalumab
Drug: 5-Fluorouracil
Drug: Volrustomig
Drug: Capecitabine
Drug: Rilvegostomig

Study type

Interventional

Funder types

Industry

Identifiers

NCT05489211
2022-000776-19 (EudraCT Number)
D926UC00001

Details and patient eligibility

About

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

Full description

This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in various advanced solid tumour types.

This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3), ovarian cancer (Substudy 4), colorectal cancer (CRC) (Substudy 5), urothelial cancer (Substudy 6) and biliary tract cancer (Substudy 7) in the advanced or metastatic setting. Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2 (Gastric Cancer) and Substudy 6 (Urothelial Cancer) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated (for all substudies except Substudy 7).

Enrollment

531 estimated patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Male and female, ≥ 18 years
  • Documented advanced or metastatic malignancy
  • Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing
  • All participants must provide a tumour sample for tissue-based analysis
  • At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease
  • Adequate bone marrow reserve and organ function
  • Minimum life expectancy of 12 weeks
  • At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • All women of childbearing potential must have a negative serum pregnancy test documented during screening
  • Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study
  • Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.
  • Capable of giving signed informed consent
  • Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative

Key Exclusion Criteria:

  • Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol
  • History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent
  • Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved
  • Spinal cord compression or brain metastases unless treated
  • Leptomeningeal carcinomatosis
  • Clinically significant corneal disease
  • Active hepatitis or uncontrolled hepatitis B or C virus infection
  • Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms
  • Known HIV infection that is not well controlled
  • Active TB infection
  • Significant cardiac diseases
  • History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required steroids
  • Has severe pulmonary function compromise
  • Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention
  • Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment
  • Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
  • Prior treatment with TROP2-directed Anti-drug antibody, ADC Antibody-drug conjugate (ADCs), other ADCs with deruxtecan payload
  • Severe hypersensitivity to monoclonal antibodies
  • Pregnant, breastfeeding, planning to become pregnant

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

531 participants in 17 patient groups

Substudy-1A
Experimental group
Description:
Dato-DXd will be evaluated as monotherapy
Treatment:
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-1B
Experimental group
Description:
Dato-Dxd in combination with Durvalumab will be evaluated
Treatment:
Drug: Durvalumab
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-1C
Experimental group
Description:
Dato-Dxd in combination with Saruparib (AZD5305) will be evaluated
Treatment:
Drug: Saruparib
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-1D
Experimental group
Description:
Dato-Dxd in combination with Durvalumab + Saruparib (AZD5305) will be evaluated
Treatment:
Drug: Durvalumab
Drug: Saruparib
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-2A
Experimental group
Description:
Dato-DXd in combination with capecitabine will be evaluated
Treatment:
Drug: Capecitabine
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-2B
Experimental group
Description:
Dato-DXd in combination with 5-FU will be evaluated
Treatment:
Drug: 5-Fluorouracil
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-2C
Experimental group
Description:
Dato-DXd in combination with chemotherapy (capecitabine or 5-FU) + volrustomig (MEDI5752) will be evaluated
Treatment:
Drug: Volrustomig
Drug: Capecitabine
Drug: 5-Fluorouracil
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-3A
Experimental group
Description:
Dato-DXd will be evaluated as monotherapy
Treatment:
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-3B
Experimental group
Description:
Dato-DXd in combination with Saruparib (AZD5305) will be evaluated
Treatment:
Drug: Saruparib
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-3C
Experimental group
Description:
Dato-DXd will be evaluated in combination with prednisone/prednisolone
Treatment:
Drug: Prednisone/ prednisolone
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-4A
Experimental group
Description:
Dato DXd will be evaluated as monotherapy
Treatment:
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-4B
Experimental group
Description:
Dato-DXd in combination with carboplatin followed by Dato-DXd + Saruparib (AZD5305) will be evaluated
Treatment:
Drug: Saruparib
Drug: Datopotamab deruxtecan (Dato-DXd)
Drug: Carboplatin
Substudy-5A
Experimental group
Description:
Dato-DXd will be evaluated as monotherapy
Treatment:
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-5B
Experimental group
Description:
Dato-DXd + 5-FU + LV + bevacizumab OR Dato-DXd + capecitabine + bevacizumab will be evaluated
Treatment:
Drug: Capecitabine
Drug: 5-Fluorouracil
Drug: Bevacizumab
Drug: Datopotamab deruxtecan (Dato-DXd)
Drug: Leucovorin LV
Substudy- 6A
Experimental group
Description:
Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated
Treatment:
Drug: Volrustomig
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy-6B
Experimental group
Description:
Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated
Treatment:
Drug: Rilvegostomig
Drug: Datopotamab deruxtecan (Dato-DXd)
Substudy- 7A
Experimental group
Description:
Dato-DXd will be evaluated as monotherapy
Treatment:
Drug: Datopotamab deruxtecan (Dato-DXd)

Trial contacts and locations

93

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Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

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